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Trial record 1 of 1 for:    IXT2
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Observation Versus Occlusion Therapy for Intermittent Exotropia (IXT2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01032330
Recruitment Status : Completed
First Posted : December 15, 2009
Results First Posted : May 8, 2019
Last Update Posted : May 19, 2020
Sponsor:
Collaborators:
Pediatric Eye Disease Investigator Group
National Eye Institute (NEI)
Information provided by (Responsible Party):
Jaeb Center for Health Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Exotropia
Intervention Device: occlusion treatment
Enrollment 611
Recruitment Details  
Pre-assignment Details Aside from the two primary cohorts (older and younger), there were 52 patients in a separate exploratory cohort of patients who had little or no stereoacuity (800 or Nil); this cohort is not being reported based on the criteria listed in the protocol.
Arm/Group Title Older Cohort Observation Group Older Cohort Occlusion Therapy Group Younger Cohort Observation Group Younger Cohort Occlusion Therapy Group
Hide Arm/Group Description Older Cohort patients aged 3 to <12 years randomized to the observation group will receive no treatment (other than refractive correction). Occlusion treatment: Older cohort patients aged 3 to <12 years randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion. Younger cohort patients aged 12 to 35 months randomized to the observation group will receive no treatment (other than refractive correction). Occlusion treatment: Younger cohort patients aged 12 to 35 months randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
Period Title: Overall Study
Started 183 175 97 104
Completed 165 151 87 90
Not Completed 18 24 10 14
Arm/Group Title Older Cohort Observation Group Older Cohort Occlusion Therapy Group Younger Cohort Observation Group Younger Cohort Occlusion Therapy Group Total
Hide Arm/Group Description Patients randomized to the observation group will receive no treatment (other than refractive correction). Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion. Patients randomized to the observation group will receive no treatment (other than refractive correction). Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion. Total of all reporting groups
Overall Number of Baseline Participants 183 175 97 104 559
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
<=18 years
183
 100.0%
175
 100.0%
97
 100.0%
104
 100.0%
559
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
6.1  (2.0) 5.9  (2.0) 2.0  (0.54) 2.0  (0.57) 6.0  (2.0)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
3 to <5 years Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
61
  33.3%
68
  38.9%
0
   0.0%
0
   0.0%
129
  23.1%
5 to <7 years Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
67
  36.6%
64
  36.6%
0
   0.0%
0
   0.0%
131
  23.4%
7 to <9 years Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
33
  18.0%
26
  14.9%
0
   0.0%
0
   0.0%
59
  10.6%
9 to <11 years Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
22
  12.0%
17
   9.7%
0
   0.0%
0
   0.0%
39
   7.0%
1 to <1.5 years Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
0
   0.0%
0
   0.0%
22
  22.7%
23
  22.1%
45
   8.1%
1.5 to <2 years Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
0
   0.0%
0
   0.0%
28
  28.9%
18
  17.3%
46
   8.2%
2 to <2.5 years Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
0
   0.0%
0
   0.0%
24
  24.7%
34
  32.7%
58
  10.4%
2.5 to <3 years Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
0
   0.0%
0
   0.0%
23
  23.7%
28
  26.9%
51
   9.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
Female
115
  62.8%
98
  56.0%
58
  59.8%
66
  63.5%
337
  60.3%
Male
68
  37.2%
77
  44.0%
39
  40.2%
38
  36.5%
222
  39.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
112
  61.2%
109
  62.3%
65
  67.0%
60
  57.7%
346
  61.9%
Black/African American Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
23
  12.6%
25
  14.3%
13
  13.4%
14
  13.5%
75
  13.4%
Hispanic or Latino Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
32
  17.5%
22
  12.6%
13
  13.4%
21
  20.2%
88
  15.7%
Other Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
14
   7.7%
13
   7.4%
6
   6.2%
9
   8.7%
42
   7.5%
Unknown/not reported Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
2
   1.1%
6
   3.4%
0
   0.0%
0
   0.0%
8
   1.4%
Average Visual Acuity   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
20/12 or 20/16 Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
21
  11.5%
22
  12.6%
0
   0.0%
0
   0.0%
43
   7.7%
20/20 Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
65
  35.5%
70
  40.0%
0
   0.0%
0
   0.0%
135
  24.2%
20/25 Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
73
  39.9%
45
  25.7%
0
   0.0%
0
   0.0%
118
  21.1%
20/32 Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
17
   9.3%
28
  16.0%
0
   0.0%
0
   0.0%
45
   8.1%
20/40 or worse Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
7
   3.8%
6
   3.4%
0
   0.0%
0
   0.0%
13
   2.3%
[1]
Measure Description: This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
Average Visual Acuity   [1] 
Mean (Standard Deviation)
Unit of measure:  logMAR
Number Analyzed 183 participants 175 participants 0 participants 0 participants 358 participants
0.04  (.09) 0.04  (.10) 0.04  (0.10)
[1]
Measure Analysis Population Description: This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
Interocular difference in visual acuity (lines)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
0 Number Analyzed 183 participants 175 participants 0 participants 0 participants 358 participants
86
  47.0%
85
  48.6%
171
  47.8%
>0 to<1 Number Analyzed 183 participants 175 participants 0 participants 0 participants 358 participants
45
  24.6%
37
  21.1%
82
  22.9%
1 Number Analyzed 183 participants 175 participants 0 participants 0 participants 358 participants
42
  23.0%
43
  24.6%
85
  23.7%
>1 to<2 Number Analyzed 183 participants 175 participants 0 participants 0 participants 358 participants
4
   2.2%
5
   2.9%
9
   2.5%
2 Number Analyzed 183 participants 175 participants 0 participants 0 participants 358 participants
6
   3.3%
1
   0.6%
7
   2.0%
[1]
Measure Analysis Population Description: This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
Interocular difference in visual acuity (lines)   [1] 
Mean (Standard Deviation)
Unit of measure:  logMAR
Number Analyzed 183 participants 175 participants 0 participants 0 participants 358 participants
0.05  (0.06) 0.04  (0.05) 0.04  (0.05)
[1]
Measure Analysis Population Description: This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
Spectacle Wear  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
42
  23.0%
38
  21.7%
5
   5.2%
9
   8.7%
94
  16.8%
Preschool Randot Near Stereoacuity (arcsec)   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
40 Number Analyzed 183 participants 175 participants 0 participants 0 participants 358 participants
75
  41.0%
69
  39.4%
144
  40.2%
60 Number Analyzed 183 participants 175 participants 0 participants 0 participants 358 participants
39
  21.3%
43
  24.6%
82
  22.9%
100 Number Analyzed 183 participants 175 participants 0 participants 0 participants 358 participants
43
  23.5%
25
  14.3%
68
  19.0%
200 Number Analyzed 183 participants 175 participants 0 participants 0 participants 358 participants
19
  10.4%
16
   9.1%
35
   9.8%
400 Number Analyzed 183 participants 175 participants 0 participants 0 participants 358 participants
7
   3.8%
22
  12.6%
29
   8.1%
[1]
Measure Description: Stereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity.
[2]
Measure Analysis Population Description: This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
Preschool Randot Near Stereoacuity (arcsec)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Log arcsec
Number Analyzed 183 participants 175 participants 0 participants 0 participants 358 participants
1.84  (0.27) 1.89  (0.34) 1.87  (0.31)
[1]
Measure Description:

Stereoacuity scores (seconds of arc, or arcsec) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity.

A logarithm base 10 transformation was used to convert stereoacuity scores to the log scale to calculate descriptive statistics (reported as log of seconds of arc, or log arcsec).

[2]
Measure Analysis Population Description: This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
Distance Randot Stereoacuity (arcsec)   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
60 Number Analyzed 183 participants 175 participants 0 participants 0 participants 358 participants
64
  35.0%
77
  44.0%
141
  39.4%
100 Number Analyzed 183 participants 175 participants 0 participants 0 participants 358 participants
39
  21.3%
38
  21.7%
77
  21.5%
200 Number Analyzed 183 participants 175 participants 0 participants 0 participants 358 participants
30
  16.4%
23
  13.1%
53
  14.8%
400 Number Analyzed 183 participants 175 participants 0 participants 0 participants 358 participants
18
   9.8%
20
  11.4%
38
  10.6%
Nil Number Analyzed 183 participants 175 participants 0 participants 0 participants 358 participants
28
  15.3%
16
   9.1%
44
  12.3%
[1]
Measure Description: Stereoacuity scores (seconds of arc, or arcsec) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity.
[2]
Measure Analysis Population Description: This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
Distance Randot Stereoacuity (arcsec)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Log arcsec
Number Analyzed 183 participants 175 participants 0 participants 0 participants 358 participants
2.22  (0.50) 2.12  (0.44) 2.17  (0.47)
[1]
Measure Description:

Stereoacuity scores (seconds of arc, or arcsec) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity.

A logarithm base 10 transformation was used to convert stereoacuity scores to the log scale to calculate descriptive statistics (reported as log of seconds of arc, or log arcsec).

[2]
Measure Analysis Population Description: This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
Exotropia Type   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
Basic
127
  69.4%
119
  68.0%
61
  62.9%
71
  68.3%
378
  67.6%
Convergence insufficiency
5
   2.7%
0
   0.0%
2
   2.1%
1
   1.0%
8
   1.4%
High AC/A
4
   2.2%
7
   4.0%
2
   2.1%
0
   0.0%
13
   2.3%
Pseudodivergence excess
39
  21.3%
39
  22.3%
26
  26.8%
24
  23.1%
128
  22.9%
True divergence excess
7
   3.8%
10
   5.7%
5
   5.2%
8
   7.7%
30
   5.4%
Missing exotropia classification
1
   0.5%
0
   0.0%
1
   1.0%
0
   0.0%
2
   0.4%
[1]
Measure Description: AC/A= accommodative convergence to accommodation ratio
Deviation Type  
Measure Type: Count of Participants
Unit of measure:  Participants
Distance Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
Constant exotropia
9
   4.9%
8
   4.6%
9
   9.3%
3
   2.9%
29
   5.2%
Intermittent exotropia
174
  95.1%
167
  95.4%
88
  90.7%
101
  97.1%
530
  94.8%
Exophoria
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
No Exodeviation
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Near Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
Constant exotropia
1
   0.5%
1
   0.6%
0
   0.0%
0
   0.0%
2
   0.4%
Intermittent exotropia
129
  70.5%
119
  68.0%
69
  71.1%
72
  69.2%
389
  69.6%
Exophoria
49
  26.8%
44
  25.1%
21
  21.6%
21
  20.2%
135
  24.2%
No Exodeviation
4
   2.2%
11
   6.3%
7
   7.2%
11
  10.6%
33
   5.9%
Exotropia (∆) by Simultaneous Prism Cover Test (SPCT)   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Distance Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
0 (no measureable tropia)
48
  26.2%
50
  28.6%
28
  28.9%
41
  39.4%
167
  29.9%
1-9
15
   8.2%
18
  10.3%
8
   8.2%
7
   6.7%
48
   8.6%
10-14
18
   9.8%
12
   6.9%
4
   4.1%
5
   4.8%
39
   7.0%
16-18
30
  16.4%
29
  16.6%
8
   8.2%
13
  12.5%
80
  14.3%
20-25
57
  31.1%
47
  26.9%
30
  30.9%
21
  20.2%
155
  27.7%
30-35
13
   7.1%
15
   8.6%
16
  16.5%
12
  11.5%
56
  10.0%
40-50
2
   1.1%
4
   2.3%
3
   3.1%
3
   2.9%
12
   2.1%
>50
0
   0.0%
0
   0.0%
0
   0.0%
2
   1.9%
2
   0.4%
Near Number Analyzed 183 participants 175 participants 97 participants 103 participants 558 participants
0 (no measureable tropia)
108
  59.0%
108
  61.7%
63
  64.9%
75
  72.8%
354
  63.4%
1-9
23
  12.6%
27
  15.4%
11
  11.3%
8
   7.8%
69
  12.4%
10-14
21
  11.5%
11
   6.3%
4
   4.1%
3
   2.9%
39
   7.0%
16-18
13
   7.1%
12
   6.9%
3
   3.1%
4
   3.9%
32
   5.7%
20-25
14
   7.7%
9
   5.1%
12
  12.4%
9
   8.7%
44
   7.9%
30-35
4
   2.2%
5
   2.9%
3
   3.1%
3
   2.9%
15
   2.7%
40-50
0
   0.0%
3
   1.7%
1
   1.0%
1
   1.0%
5
   0.9%
>50
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: The Simultaneous Prism and Cover Test (SPCT) is performed by covering the fixating eye at the same time the prism is placed in front of the deviating eye. Prism diopters are the measure.
[2]
Measure Analysis Population Description: One participant was missing SPCT at near
Average Exotropia (∆) by SPCT   [1] 
Median (Full Range)
Unit of measure:  Prism Diopters
Distance Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
16
(0 to 45)
16
(0 to 45)
20
(0 to 50)
14
(0 to 50)
16
(0 to 50)
Near Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
0
(0 to 30)
0
(0 to 45)
0
(0 to 45)
0
(0 to 40)
0
(0 to 45)
[1]
Measure Description: The Simultaneous Prism and Cover Test (SPCT) is performed by covering the fixating eye at the same time the prism is placed in front of the deviating eye. Prism diopters are the measure.
Exodeviation (∆) by Prism and Alternate Cover Test (PACT)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Distance Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
No exodeviation (orthophoria)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1-9
0
   0.0%
0
   0.0%
00
   0.0%
0
   0.0%
0
   0.0%
10-14
7
   3.8%
11
   6.3%
0
   0.0%
0
   0.0%
18
   3.2%
16-18
34
  18.6%
33
  18.9%
9
   9.3%
14
  13.5%
90
  16.1%
20-25
101
  55.2%
87
  49.7%
44
  45.4%
44
  42.3%
276
  49.4%
30-35
35
  19.1%
39
  22.3%
39
  40.2%
36
  34.6%
149
  26.7%
40-45
5
   2.7%
5
   2.9%
3
   3.1%
8
   7.7%
21
   3.8%
≥50
1
   0.5%
0
   0.0%
2
   2.1%
2
   1.9%
5
   0.9%
Near Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
No exodeviation (orthophoria)
6
   3.3%
7
   4.0%
9
   9.3%
13
  12.5%
35
   6.3%
1-9
19
  10.4%
31
  17.7%
7
   7.2%
8
   7.7%
65
  11.6%
10-14
49
  26.8%
45
  25.7%
24
  24.7%
15
  14.4%
133
  23.8%
16-18
32
  17.5%
24
  13.7%
9
   9.3%
13
  12.5%
78
  14.0%
20-25
52
  28.4%
48
  27.4%
30
  30.9%
30
  28.8%
160
  28.6%
30-35
21
  11.5%
15
   8.6%
14
  14.4%
18
  17.3%
68
  12.2%
40-45
4
   2.2%
5
   2.9%
3
   3.1%
5
   4.8%
17
   3.0%
≥50
0
   0.0%
0
   0.0%
1
   1.0%
2
   1.9%
3
   0.5%
[1]
Measure Description: The prism and alternate cover test (PACT) is used to measure the angle of strabismus, or deviation, in prism diopters. This is measured separately at distance and at near. Smaller numbers are better because they indicate a smaller angle of deviation.
Average Exodeviation (∆) by PACT   [1] 
Mean (Standard Deviation)
Unit of measure:  Prism Diopters
Distance Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
23.3  (6.7) 23.6  (6.7) 27.4  (7.1) 27.2  (8.2) 24.8  (7.3)
Near Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
18.0  (8.9) 16.7  (9.3) 18.1  (10.8) 19.4  (12.1) 17.8  (10.0)
[1]
Measure Description: The prism and alternate cover test (PACT) is used to measure the angle of strabismus, or deviation, in prism diopters. This is measured separately at distance and at near. Smaller numbers are better because they indicate a smaller angle of deviation.
Exotropia control score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Distance Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
No exodeviation
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
No XT unless dissociated, recovers <1 sec
5
   2.7%
5
   2.9%
2
   2.1%
2
   1.9%
14
   2.5%
No XT unless dissociated, recovers 1-5 sec
34
  18.6%
47
  26.9%
18
  18.6%
27
  26.0%
126
  22.5%
No XT unless dissociated, recovers >5 sec
71
  38.8%
56
  32.0%
38
  39.2%
33
  31.7%
198
  35.4%
XT <50% of 30-seconds
40
  21.9%
37
  21.1%
19
  19.6%
27
  26.0%
123
  22.0%
XT >50% of 30-seconds
21
  11.5%
19
  10.9%
11
  11.3%
11
  10.6%
62
  11.1%
Constant XT
12
   6.6%
11
   6.3%
9
   9.3%
4
   3.8%
36
   6.4%
Near Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
No exodeviation
5
   2.7%
7
   4.0%
3
   3.1%
10
   9.6%
25
   4.5%
No XT unless dissociated, recovers <1 sec
58
  31.7%
58
  33.1%
31
  32.0%
28
  26.9%
175
  31.3%
No XT unless dissociated, recovers 1-5 sec
71
  38.8%
63
  36.0%
30
  30.9%
39
  37.5%
203
  36.3%
No XT unless dissociated, recovers >5 sec
28
  15.3%
26
  14.9%
17
  17.5%
15
  14.4%
86
  15.4%
XT <50% of 30-seconds
18
   9.8%
14
   8.0%
12
  12.4%
11
  10.6%
55
   9.8%
XT >50% of 30-seconds
2
   1.1%
7
   4.0%
4
   4.1%
1
   1.0%
14
   2.5%
Constant XT
1
   0.5%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.2%
[1]
Measure Description:

Numeric values for exotropia control were assigned so that the following categories were created:

Not applicable (no exodeviation) 0: No exotropia unless dissociated, recovers <1 secs (phoria)

  1. No exotropia unless dissociated, recovers 1-5 secs
  2. No exotropia unless dissociated, recovers >5 secs
  3. Exotropia <50% of 30-second observation
  4. Exotropia >50% of 30-second observation
  5. Constant exotropia

Lower scores indicate better control.

Average Exotropia Control Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Distance Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
2.4  (1.2) 2.3  (1.2) 2.5  (1.2) 2.3  (1.1) 2.4  (1.2)
Near Number Analyzed 183 participants 175 participants 97 participants 104 participants 559 participants
1.1  (1.0) 1.1  (1.1) 1.2  (1.2) 1.0  (1.0) 1.1  (1.1)
[1]
Measure Description:

Numeric values for exotropia control were assigned so that the following categories were created:

Not applicable (no exodeviation) 0: No exotropia unless dissociated, recovers <1 secs (phoria)

  1. No exotropia unless dissociated, recovers 1-5 secs
  2. No exotropia unless dissociated, recovers >5 secs
  3. Exotropia <50% of 30-second observation
  4. Exotropia >50% of 30-second observation
  5. Constant exotropia

Lower scores indicate better control.

1.Primary Outcome
Title Deterioration by 6 Months - Older Cohort
Hide Description The primary outcome measure for this study was whether the participant's condition had deteriorated within 6 months after randomization. Deterioration was defined as meeting one or both of the following criteria during a masked examination at either the 3-month or 6-month visit: 1) a constant exotropia (throughout the exam) of 10∆ or greater at distance and near by SPCT, confirmed by a retest, or 2) loss of near stereoacuity of 2 octaves (0.6 log arcsec) or more from the better of a test and retest of Preschool Randot stereoacuity at baseline, confirmed by a retest. In addition, participants were classified as deteriorated for the primary analysis if they started using non-randomized treatment (i.e., any treatment in the observation group; any treatment other than patching in the patching group) without first meeting one of the two protocol-specified deterioration criteria.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Previously untreated children aged 3 to <11 years. The 6-month primary outcome visit was completed by 165 participants (90%) in the observation group, and by 159 participants (91%) in the patching group.
Arm/Group Title Older Cohort Observation Group Older Cohort Occlusion Therapy Group
Hide Arm/Group Description:
Older cohort patients randomized to the observation group will receive no treatment (other than refractive correction).
Occlusion treatment: older cohort patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
Overall Number of Participants Analyzed 165 159
Measure Type: Count of Participants
Unit of Measure: Participants
Formal deterioration criteria met
10
   6.1%
1
   0.6%
Constant exotropia >= 10 PD at distance and near
7
   4.2%
1
   0.6%
Stereoacuity worsening of >= 2 octaves
1
   0.6%
0
   0.0%
Both criteria
0
   0.0%
0
   0.0%
Started treatment w/o meeting criteria
3
   1.8%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Older Cohort Observation Group, Older Cohort Occlusion Therapy Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method One-sided Barnard's Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.054
Confidence Interval (1-Sided) 95%
0.020
Estimation Comments [Not Specified]
2.Primary Outcome
Title Deterioration by 3 Years - Older Cohort
Hide Description The primary outcome measure for this study was whether the participant's condition had deteriorated within 3 years after randomization. Deterioration was defined as meeting one or both of the following criteria during any masked examination between 3 months and 3 years after randomization: 1) a constant exotropia (throughout the exam) of 10∆ or greater at distance and near by SPCT, confirmed by a retest, or 2) loss of near stereoacuity of 2 octaves (0.6 log arcsec) or more from the better of a test and retest of Preschool Randot stereoacuity at baseline, confirmed by a retest. In addition, participants were classified as deteriorated for the primary analysis if they started using non-randomized treatment (i.e., any treatment in the observation group; any treatment other than patching in the patching group) without first meeting one of the two protocol-specified deterioration criteria.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The clinical trial ended after 6 months, after which the purpose of the study was to observe the natural history of patients in the Observation arm. Because only half the occlusion group underwent further occlusion between 6 months and 3 years, the long-term occlusion group data was not felt to be of value, and there are no plans for its analysis.
Arm/Group Title Older Cohort Observation Group Older Cohort Occlusion Therapy Group
Hide Arm/Group Description:
Older cohort patients randomized to the observation group will receive no treatment (other than refractive correction).
This group was not reported on. The clinical trial ended after 6 months, after which the purpose of the study was to observe the natural history of patients in the Observation arm. No data were collected from participants from 6 months to 3 years, and there are no plans for analysis.
Overall Number of Participants Analyzed 183 0
Measure Type: Count of Participants
Unit of Measure: Participants
25 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Older Cohort Observation Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter cumulative probability
Estimated Value .15
Confidence Interval (2-Sided) 95%
.10 to .22
Estimation Comments Kaplan-Meier estimate of cumulative probability of deterioration by 3 years
3.Primary Outcome
Title Deterioration by 6 Months - Younger Cohort
Hide Description The primary outcome measure was deterioration of the intermittent exotropia (IXT) within 6 months after randomization. Motor deterioration was defined as a constant exotropia of 10 D or more at distance and near by SPCT, confirmed by a retest, at either the 3- or 6-month visit.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Previously untreated children aged 12 to 35 months. Motor deterioration was measured by simultaneous prism and cover test.
Arm/Group Title Younger Cohort Observation Group Younger Cohort Occlusion Therapy Group
Hide Arm/Group Description:
Younger cohort patients aged 12 to 35 months randomized to the observation group will receive no treatment (other than refractive correction).
Occlusion treatment: Younger cohort patients aged 12 to 35 months randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
Overall Number of Participants Analyzed 87 90
Measure Type: Count of Participants
Unit of Measure: Participants
Deterioration
4
   4.6%
2
   2.2%
Constant exotropia >= 10 PD at distance and near
2
   2.3%
2
   2.2%
Started nonprotocol tmt w/o motor deterioration
2
   2.3%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Younger Cohort Observation Group, Younger Cohort Occlusion Therapy Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method One-sided Barnard's Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.024
Confidence Interval (2-Sided) 95%
-0.038 to 0.094
Estimation Comments [Not Specified]
4.Primary Outcome
Title Deterioration by 3 Years - Younger Cohort
Hide Description The primary outcome measure was deterioration of the intermittent exotropia (IXT) within 6 months after randomization. Motor deterioration was defined as a constant exotropia of 10 D or more at distance and near by SPCT, confirmed by a retest, during any masked examination between 3 months and 3 years after randomization.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The younger cohort occlusion therapy group was not reported on. The clinical trial ended after 6 months, after which the purpose of the study was to observe the natural history of patients in the Observation arm. No data were collected from participants from 6 months to 3 years, and there are no plans for analysis.
Arm/Group Title Younger Cohort Observation Group Younger Cohort Occlusion Therapy Group
Hide Arm/Group Description:
Younger cohort patients aged 12 to 35 months randomized to the observation group will receive no treatment (other than refractive correction).
This group was not reported on. The clinical trial ended after 6 months, after which the purpose of the study was to observe the natural history of patients in the Observation arm. No data were collected from participants from 6 months to 3 years, and there are no plans for analysis.
Overall Number of Participants Analyzed 97 0
Measure Type: Count of Participants
Unit of Measure: Participants
24
  24.7%
0
5.Secondary Outcome
Title Distance Stereoacuity - 3 Years
Hide Description

Stereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity.

A logarithm base 10 transformation was used to convert stereoacuity scores to the log scale to calculate descriptive statistics (reported as log of seconds of arc, or log arcsec). The stereoacuity at distance is reported at 3 years, as is the change in distance stereoacuity from baseline to 3 years. Both were reported as log of seconds of arc, or log arcsec. For change in stereo, positive change indicates improvement in stereo.

Time Frame Between baseline and 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Since only half the occlusion group underwent further occlusion between 6 months and 3 years, the long-term occlusion group data was not felt to be of value, and there are no plans for its analysis. For the observation group, the number reported is those who completed the 3-Year visit and had not been prescribed treatment anytime during the study.
Arm/Group Title Older Cohort Observation Group Older Cohort Occlusion Group
Hide Arm/Group Description:
Older cohort patients randomized to the observation group will receive no treatment (other than refractive correction).
This group was not reported on. The clinical trial ended after 6 months, after which the purpose of the study was to observe the natural history of patients in the Observation arm. No data were collected from participants from 6 months to 3 years, and there are no plans for analysis.
Overall Number of Participants Analyzed 132 0
Mean (Standard Deviation)
Unit of Measure: log arsec
At 3 Years 2.03  (0.36)
Change between baseline and 3 years 0.14  (0.40)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Older Cohort Observation Group
Comments P-value for the change between baseline and 3 years. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
6.Secondary Outcome
Title Near Stereoacuity - 6 Months
Hide Description

Stereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity.

A logarithm base 10 transformation was used to convert stereoacuity scores to the log scale to calculate descriptive statistics (reported as log of seconds of arc, or log arcsec). The stereoacuity at near is reported at 3 years, as is the change in near stereoacuity from baseline to 3 years. Both were reported as log of seconds of arc, or log arcsec.

Outcome based on initial testing regardless of whether a retest was completed for suspected deterioration. Change is calculated as baseline level minus 6-month level. For change in stereo, positive change indicates improvement in stereo.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Stereoacuity data is missing for 2 observation group participants because it was not tested at the visit at which treatment was started in the absence of meeting deterioration criteria. The 6-month primary outcome visit was completed by 165 participants (90%) in the observation group, and by 159 participants (91%) in the patching group.
Arm/Group Title Older Cohort Observation Group Older Cohort Occlusion Therapy Group
Hide Arm/Group Description:
Older cohort patients randomized to the observation group will receive no treatment (other than refractive correction).
Occlusion treatment: older cohort patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
Overall Number of Participants Analyzed 165 159
Mean (Standard Deviation)
Unit of Measure: log arsec
At 6 months 1.84  (0.33) 1.84  (0.31)
Change between Baseline and 6 months 0.00  (0.32) 0.06  (0.30)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Older Cohort Observation Group, Older Cohort Occlusion Therapy Group
Comments Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome; P values for comparisons of binary outcomes are from logistic regression models adjusting for the baseline level of the outcome.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
7.Secondary Outcome
Title Near Stereoacuity - 3 Years
Hide Description

Stereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity.

A logarithm base 10 transformation was used to convert stereoacuity scores to the log scale to calculate descriptive statistics (reported as log of seconds of arc, or log arcsec). The stereoacuity at near is reported at 3 years, as is the change in near stereoacuity from baseline to 3 years. Both were reported as log of seconds of arc, or log arcsec. For change in stereo, positive change indicates improvement in stereo.

Time Frame between baseline and 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The older cohort occlusion therapy group was not reported on. The clinical trial ended after 6 months, after which the purpose of the study was to observe the natural history of patients in the Observation arm. No data were collected from participants from 6 months to 3 years, and there are no plans for analysis.
Arm/Group Title Older Cohort Observation Group Older Cohort Occlusion Therapy Group
Hide Arm/Group Description:
Older cohort patients randomized to the observation group will receive no treatment (other than refractive correction).
This group was not reported on. The clinical trial ended after 6 months, after which the purpose of the study was to observe the natural history of patients in the Observation arm. No data were collected from participants from 6 months to 3 years, and there are no plans for analysis.
Overall Number of Participants Analyzed 132 0
Mean (Standard Deviation)
Unit of Measure: log arcsec
At 3 Years 1.7  (0.21)
Change between Baseline and 3 Years 0.14  (0.29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Older Cohort Observation Group
Comments P-value for the change between baseline and 3 years. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
8.Secondary Outcome
Title Exotropia Control at Distance - 6 Months
Hide Description

Change in control is calculated as baseline level minus 3-year level, so positive change = improvement. Scale Range: 0 to 5. Improvement in control was defined as an improvement of 3 points based on the 3-point threshold for real change.

Numeric values for exotropia control were assigned so that the following categories were created:

Not applicable (no exodeviation) 0: No exotropia unless dissociated, recovers <1 secs (phoria)

  1. No exotropia unless dissociated, recovers 1-5 secs
  2. No exotropia unless dissociated, recovers >5 secs
  3. Exotropia <50% of 30-second observation
  4. Exotropia >50% of 30-second observation
  5. Constant exotropia

Lower scores indicate better control.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
For the Older Cohort, the 6-month primary outcome visit was completed by 165 participants (90%) in the observation group, and by 159 participants (91%) in the patching group.
Arm/Group Title Older Cohort Observation Group Older Cohort Occlusion Therapy Group Younger Cohort Observation Group Younger Cohort Occlusion Therapy Group
Hide Arm/Group Description:
Patients randomized to the observation group will receive no treatment (other than refractive correction).
Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
Patients randomized to the observation group will receive no treatment (other than refractive correction).
Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
Overall Number of Participants Analyzed 165 159 87 90
Mean (Standard Deviation)
Unit of Measure: score on a scale
At 6 months 2.3  (1.4) 2.0  (1.2) 2.8  (1.3) 2.3  (1.5)
Change between Baseline and 6 months 0.1  (1.4) 0.3  (1.4) -0.3  (1.3) 0.1  (1.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Older Cohort Observation Group, Older Cohort Occlusion Therapy Group
Comments P-value for the change between baseline and 6 months in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Younger Cohort Observation Group, Younger Cohort Occlusion Therapy Group
Comments P-value for the change between baseline and 6 months in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
9.Secondary Outcome
Title Exotropia Control at Distance - 3 Years
Hide Description

Change in control is calculated as baseline level minus 3-year level, so positive change = improvement. Scale Range: 0 to 5. Improvement in control was defined as an improvement of 3 points based on the 3-point threshold for real change.

Numeric values for exotropia control were assigned so that the following categories were created:

Not applicable (no exodeviation) 0: No exotropia unless dissociated, recovers <1 secs (phoria)

  1. No exotropia unless dissociated, recovers 1-5 secs
  2. No exotropia unless dissociated, recovers >5 secs
  3. Exotropia <50% of 30-second observation
  4. Exotropia >50% of 30-second observation
  5. Constant exotropia

Lower scores indicate better control.

Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Since only half the occlusion group underwent further occlusion between 6 months and 3 years, the long-term occlusion group data was not felt to be of value, and there are no plans for its analysis. For the observation groups, the number reported is those who completed the 3-Year visit and had not been prescribed treatment anytime during the study.
Arm/Group Title Older Cohort Observation Group Older Cohort Occlusion Group Younger Cohort Observation Group Younger Cohort Occlusion Group
Hide Arm/Group Description:
Patients randomized to the observation group will receive no treatment (other than refractive correction).
This group was not reported on. The clinical trial ended after 6 months, after which the purpose of the study was to observe the natural history of patients in the Observation arm. No data were collected from participants from 6 months to 3 years, and there are no plans for analysis.
Patients randomized to the observation group will receive no treatment (other than refractive correction).
This group was not reported on. The clinical trial ended after 6 months, after which the purpose of the study was to observe the natural history of patients in the Observation arm. No data were collected from participants from 6 months to 3 years, and there are no plans for analysis.
Overall Number of Participants Analyzed 132 0 53 0
Mean (Standard Deviation)
Unit of Measure: score on a scale
At 3 Years 1.8  (1.4) 2.2  (1.5)
Change between Baseline and 3 Years 0.6  (1.5) 0.2  (1.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Older Cohort Observation Group
Comments P-value for the change between baseline and 3 Years in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Younger Cohort Observation Group
Comments P-value for the change between baseline and 3 Years in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
10.Secondary Outcome
Title Exotropia Control at Near - 6 Months
Hide Description

Change in control is calculated as baseline level minus 3-year level, so positive change = improvement. Scale Range: 0 to 5. Improvement in control was defined as an improvement of 3 points based on the 3-point threshold for real change.

Numeric values for exotropia control were assigned so that the following categories were created:

Not applicable (no exodeviation) 0: No exotropia unless dissociated, recovers <1 secs (phoria)

  1. No exotropia unless dissociated, recovers 1-5 secs
  2. No exotropia unless dissociated, recovers >5 secs
  3. Exotropia <50% of 30-second observation
  4. Exotropia >50% of 30-second observation
  5. Constant exotropia

Lower scores indicate better control.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
For the Older Cohort, the 6-month primary outcome visit was completed by 165 participants (90%) in the observation group, and by 159 participants (91%) in the patching group.
Arm/Group Title Older Cohort Observation Group Older Cohort Occlusion Therapy Group Younger Cohort Observation Group Younger Cohort Occlusion Therapy Group
Hide Arm/Group Description:
Patients randomized to the observation group will receive no treatment (other than refractive correction).
Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
Patients randomized to the observation group will receive no treatment (other than refractive correction).
Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
Overall Number of Participants Analyzed 165 159 87 90
Mean (Standard Deviation)
Unit of Measure: score on a scale
A 6 months 1.2  (1.1) 0.9  (1.1) 1.4  (1.4) 1.1  (1.4)
Change between Baseline and 6 months -0.2  (1.1) 0.1  (1.1) -0.3  (1.1) -0.1  (1.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Older Cohort Observation Group, Older Cohort Occlusion Therapy Group
Comments P-value for the change between baseline and 6 months in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Younger Cohort Observation Group, Younger Cohort Occlusion Therapy Group
Comments P-value for the change between baseline and 6 months in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
11.Secondary Outcome
Title Exotropia Control at Near - 3 Years
Hide Description

Change in control is calculated as baseline level minus 3-year level, so positive change = improvement. Scale Range: 0 to 5. Improvement in control was defined as an improvement of 3 points based on the 3-point threshold for real change.

Numeric values for exotropia control were assigned so that the following categories were created:

Not applicable (no exodeviation) 0: No exotropia unless dissociated, recovers <1 secs (phoria)

  1. No exotropia unless dissociated, recovers 1-5 secs
  2. No exotropia unless dissociated, recovers >5 secs
  3. Exotropia <50% of 30-second observation
  4. Exotropia >50% of 30-second observation
  5. Constant exotropia

Lower scores indicate better control.

Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Since only half the occlusion group underwent further occlusion between 6 months and 3 years, the long-term occlusion group data was not felt to be of value, and there are no plans for its analysis. For the observation groups, the number reported is those who completed the 3-Year visit and had not been prescribed treatment anytime during the study.
Arm/Group Title Older Cohort Observation Group Older Cohort Occlusion Group Younger Cohort Observation Group Younger Cohort Occlusion Group
Hide Arm/Group Description:
Patients randomized to the observation group will receive no treatment (other than refractive correction).
This group was not reported on. The clinical trial ended after 6 months, after which the purpose of the study was to observe the natural history of patients in the Observation arm. No data were collected from participants from 6 months to 3 years, and there are no plans for analysis.
Patients randomized to the observation group will receive no treatment (other than refractive correction).
This group was not reported on. The clinical trial ended after 6 months, after which the purpose of the study was to observe the natural history of patients in the Observation arm. No data were collected from participants from 6 months to 3 years, and there are no plans for analysis.
Overall Number of Participants Analyzed 132 0 53 0
Mean (Standard Deviation)
Unit of Measure: score on a scale
At 3 Years 0.9  (1.1) 1.0  (1.4)
Change between Baseline and 3 Years 0.1  (1.2) 0.1  (1.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Older Cohort Observation Group
Comments P-value for the change between baseline and 3 Years in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Younger Cohort Observation Group
Comments P-value for the change between baseline and 3 Years in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
12.Secondary Outcome
Title PACT Exodeviation at Distance - 6 Months
Hide Description

The prism and alternate cover test (PACT) is used to measure the angle of strabismus, or deviation, in prism diopters. This is measured separately at distance and at near. Smaller numbers are better because they indicate a smaller angle of deviation. For change in PACT, positive change indicates improvement (i.e. decrease in angle over time).

log arcsec = logarithm of seconds of arc; Δ = prism diopter

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
For the Older Cohort, the 6-month primary outcome visit was completed by 165 participants (90%) in the observation group, and by 159 participants (91%) in the patching group.
Arm/Group Title Older Cohort Observation Group Older Cohort Occlusion Therapy Group Younger Cohort Observation Group Younger Cohort Occlusion Therapy Group
Hide Arm/Group Description:
Patients randomized to the observation group will receive no treatment (other than refractive correction).
Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
Patients randomized to the observation group will receive no treatment (other than refractive correction).
Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
Overall Number of Participants Analyzed 165 159 87 90
Mean (Standard Deviation)
Unit of Measure: prism diopters
At 6 months 23.8  (7.8) 22.2  (7.4) 27.9  (8.2) 24.9  (9.4)
Change between Baseline and 6 months -0.3  (6.8) 1.4  (5.8) -0.6  (8.1) 2.0  (8.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Older Cohort Observation Group, Older Cohort Occlusion Therapy Group
Comments P-value for the change between baseline and 6 months in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Younger Cohort Observation Group, Younger Cohort Occlusion Therapy Group
Comments P-value for the change between baseline and 6 months in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
13.Secondary Outcome
Title PACT at Distance - 3 Years
Hide Description

The prism and alternate cover test (PACT) is used to measure the angle of strabismus, or deviation, in prism diopters. This is measured separately at distance and at near. Smaller numbers are better because they indicate a smaller angle of deviation. For change in PACT, positive change indicates improvement (i.e. decrease in angle over time). Improvement in PACT at distance was defined as a decrease of ≥8∆ because this amount exceed the repeatability coefficient of 7.2∆ for PACT angles larger than 20∆ at distance.

log arcsec = logarithm of seconds of arc; Δ = prism diopter

Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Since only half the occlusion group underwent further occlusion between 6 months and 3 years, the long-term occlusion group data was not felt to be of value, and there are no plans for its analysis. For the observation groups, the number reported is those who completed the 3-Year visit and had not been prescribed treatment anytime during the study.
Arm/Group Title Older Cohort Observation Group Older Cohort Occlusion Group Younger Cohort Observation Group Younger Cohort Occlusion Group
Hide Arm/Group Description:
Patients randomized to the observation group will receive no treatment (other than refractive correction).
This group was not reported on. The clinical trial ended after 6 months, after which the purpose of the study was to observe the natural history of patients in the Observation arm. No data were collected from participants from 6 months to 3 years, and there are no plans for analysis.
Patients randomized to the observation group will receive no treatment (other than refractive correction).
This group was not reported on. The clinical trial ended after 6 months, after which the purpose of the study was to observe the natural history of patients in the Observation arm. No data were collected from participants from 6 months to 3 years, and there are no plans for analysis.
Overall Number of Participants Analyzed 132 0 53 0
Mean (Standard Deviation)
Unit of Measure: prism diopters
At 3 Years 21.0  (8.7) 23.4  (9.5)
Change between Baseline and 3 Years 2.2  (8.3) 3.6  (10.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Older Cohort Observation Group
Comments P-value for the change between baseline and 3 Years in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Younger Cohort Observation Group
Comments P-value for the change between baseline and 3 Years in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
14.Secondary Outcome
Title PACT at Near - 6 Months
Hide Description

The prism and alternate cover test (PACT) is used to measure the angle of strabismus, or deviation, in prism diopters. This is measured separately at distance and at near. Smaller numbers are better because they indicate a smaller angle of deviation. For change in PACT, positive change indicates improvement (i.e. decrease in angle over time).

log arcsec = logarithm of seconds of arc; Δ = prism diopter

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
For the Older Cohort, the 6-month primary outcome visit was completed by 165 participants (90%) in the observation group, and by 159 participants (91%) in the patching group.
Arm/Group Title Older Cohort Observation Group Older Cohort Occlusion Therapy Group Younger Cohort Observation Group Younger Cohort Occlusion Therapy Group
Hide Arm/Group Description:
Patients randomized to the observation group will receive no treatment (other than refractive correction).
Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
Patients randomized to the observation group will receive no treatment (other than refractive correction).
Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
Overall Number of Participants Analyzed 165 159 87 90
Mean (Standard Deviation)
Unit of Measure: prism diopters
At 6 months 17.6  (9.6) 15.4  (10.1) 19.3  (9.6) 17.0  (12.2)
Change between Baseline and 6 months 0.5  (7.8) 1.5  (8.0) -1.8  (11.4) 0.9  (12.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Older Cohort Observation Group, Older Cohort Occlusion Therapy Group
Comments P-value for the change between baseline and 6 months in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Younger Cohort Observation Group, Younger Cohort Occlusion Therapy Group
Comments P-value for the change between baseline and 6 months in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
15.Secondary Outcome
Title PACT at Near - 3 Years
Hide Description

The prism and alternate cover test (PACT) is used to measure the angle of strabismus, or deviation, in prism diopters. This is measured separately at distance and at near. Smaller numbers are better because they indicate a smaller angle of deviation. For change in PACT, positive change indicates improvement (i.e. decrease in angle over time).

Improvement in PACT at near was defined as a decrease of ≥13∆ because this amount exceed the repeatability coefficient of 12.8∆ for PACT angles larger than 20∆ at near.

log arcsec = logarithm of seconds of arc; Δ = prism diopter

Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Since only half the occlusion group underwent further occlusion between 6 months and 3 years, the long-term occlusion group data was not felt to be of value, and there are no plans for its analysis. For the observation groups, the number reported is those who completed the 3-Year visit and had not been prescribed treatment anytime during the study.
Arm/Group Title Older Cohort Observation Group Older Cohort Occlusion Group Younger Cohort Observation Group Younger Cohort Occlusion Group
Hide Arm/Group Description:
Patients randomized to the observation group will receive no treatment (other than refractive correction).
This group was not reported on. The clinical trial ended after 6 months, after which the purpose of the study was to observe the natural history of patients in the Observation arm. No data were collected from participants from 6 months to 3 years, and there are no plans for analysis.
Patients randomized to the observation group will receive no treatment (other than refractive correction).
This group was not reported on. The clinical trial ended after 6 months, after which the purpose of the study was to observe the natural history of patients in the Observation arm. No data were collected from participants from 6 months to 3 years, and there are no plans for analysis.
Overall Number of Participants Analyzed 132 0 53 0
Mean (Standard Deviation)
Unit of Measure: prism diopters
At 3 Years 17.0  (10.1) 14.9  (10.3)
Change between Baseline and 3 Years 0.4  (9.3) 2.8  (12.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Older Cohort Observation Group
Comments P-value for the change between baseline and 3 Years in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Younger Cohort Observation Group
Comments P-value for the change between baseline and 3 Years in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Older Cohort Observation Group Older Cohort Occlusion Therapy Group Younger Cohort Observation Group Younger Cohort Occlusion Therapy Group
Hide Arm/Group Description Older Cohort patients aged 3 to <12 years randomized to the observation group will receive no treatment (other than refractive correction). Occlusion treatment: Older cohort patients aged 3 to <12 years randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion. Younger cohort patients aged 12 to 35 months randomized to the observation group will receive no treatment (other than refractive correction). Occlusion treatment: Younger cohort patients aged 12 to 35 months randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
All-Cause Mortality
Older Cohort Observation Group Older Cohort Occlusion Therapy Group Younger Cohort Observation Group Younger Cohort Occlusion Therapy Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/183 (0.00%)   0/175 (0.00%)   0/97 (0.00%)   0/104 (0.00%) 
Hide Serious Adverse Events
Older Cohort Observation Group Older Cohort Occlusion Therapy Group Younger Cohort Observation Group Younger Cohort Occlusion Therapy Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/183 (0.00%)   0/175 (0.00%)   0/97 (0.00%)   0/104 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Older Cohort Observation Group Older Cohort Occlusion Therapy Group Younger Cohort Observation Group Younger Cohort Occlusion Therapy Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/183 (0.00%)   0/175 (0.00%)   0/97 (0.00%)   0/104 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Raymond Kraker, M.S.P.H., Director of PEDIG Coordinating Center
Organization: Jaeb Center for Health Research
Phone: 813-975-8690
EMail: rkraker@jaeb.org
Publications of Results:
Layout table for additonal information
Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT01032330    
Other Study ID Numbers: NEI-146
2U10EY011751 ( U.S. NIH Grant/Contract )
First Submitted: December 11, 2009
First Posted: December 15, 2009
Results First Submitted: April 6, 2017
Results First Posted: May 8, 2019
Last Update Posted: May 19, 2020