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Convergence Insufficiency Treatment Study (CITS)

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ClinicalTrials.gov Identifier: NCT01515943
Recruitment Status : Completed
First Posted : January 24, 2012
Results First Posted : August 5, 2016
Last Update Posted : April 12, 2017
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: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Convergence Insufficiency
Interventions Other: Active home-based computer vergence/accommodative therapy
Procedure: Near target push-ups
Other: Placebo home-based computer vergence/accommodative therapy
Procedure: Placebo yoked prism flippers
Enrollment 204
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Computer-based Therapy (CBT) Near Target Push-up (NTP) Placebo
Hide Arm/Group Description

The CBT group will be assigned active home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.

Active home-based computer vergence/accommodative therapy: At enrollment, subjects will be prescribed 15 minutes/day of active home-based computer therapy for 5 days/week during the 12 week treatment phase. Active home-based computer therapy will be provided the Home Therapy System (HTS) computer software and will include both fusional vergence and accommodative therapy. Subjects will perform the computer therapy while wearing red/blue glasses and accommodative therapy will be performed using the HTS accommodative flippers. Please refer to the procedures manual for further details.

Placebo yoked prism flippers: Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5 days/week during the 12 week treatment

The NTP group will be assigned placebo home-based computer vergence/accommodative therapy (5 minutes/day) plus near target push-ups (15 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.

Near target push-ups: At enrollment, subjects will be prescribed 15 minutes/day (3 sessions of 5 minutes each) of near target push-ups (NTP) for 5 days/week during the 12-week treatment phase. An alphabet pencil will be used as the target and an index card placed in the background will provide physiological diplopia control. With the pencil positioned at arm's length directly between the subject's eyes, the subject will slowly bring the pencil toward his/her nose while focusing on the small letter on the pencil. When the subject is no longer able to maintain a single image of the pencil, he/she will slowly move the target away from the nose until the pencil becomes single again. This procedure will be repeated several times.

The placebo group will be assigned placebo home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.

Placebo home-based computer vergence/accommodative therapy: At enrollment, subjects will be prescribed either 5 minutes/day (NTP group) or 15 minutes/day (Placebo group) of placebo home-based computer therapy for 5 days/week during the 12 week treatment phase. Placebo computer-based therapy will be provided by the Home Therapy System (HTS) computer software. The vergence procedures are similar to the active version, however, the tasks will be modified to ensure no demand on the vergence system and no accommodative therapy is included in the placebo version. Please refer to the procedures manual for further details.

Placebo yoked prism flippers: Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5

Period Title: Overall Study
Started 75 85 44
Completed 69 69 31
Not Completed 6 16 13
Arm/Group Title Computer-based Therapy (CBT) Near Target Push-up (NTP) Placebo Total
Hide Arm/Group Description

The CBT group will be assigned active home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.

Active home-based computer vergence/accommodative therapy: At enrollment, subjects will be prescribed 15 minutes/day of active home-based computer therapy for 5 days/week during the 12 week treatment phase. Active home-based computer therapy will be provided the Home Therapy System (HTS) computer software and will include both fusional vergence and accommodative therapy. Subjects will perform the computer therapy while wearing red/blue glasses and accommodative therapy will be performed using the HTS accommodative flippers. Please refer to the procedures manual for further details.

Placebo yoked prism flippers: Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5 days/week during the 12 week treatment

The NTP group will be assigned placebo home-based computer vergence/accommodative therapy (5 minutes/day) plus near target push-ups (15 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.

Near target push-ups: At enrollment, subjects will be prescribed 15 minutes/day (3 sessions of 5 minutes each) of near target push-ups (NTP) for 5 days/week during the 12-week treatment phase. An alphabet pencil will be used as the target and an index card placed in the background will provide physiological diplopia control. With the pencil positioned at arm's length directly between the subject's eyes, the subject will slowly bring the pencil toward his/her nose while focusing on the small letter on the pencil. When the subject is no longer able to maintain a single image of the pencil, he/she will slowly move the target away from the nose until the pencil becomes single again. This procedure will be repeated several times. Please refer to the pr

The placebo group will be assigned placebo home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.

Placebo home-based computer vergence/accommodative therapy: At enrollment, subjects will be prescribed either 5 minutes/day (NTP group) or 15 minutes/day (Placebo group) of placebo home-based computer therapy for 5 days/week during the 12 week treatment phase. Placebo computer-based therapy will be provided by the Home Therapy System (HTS) computer software. The vergence procedures are similar to the active version, however, the tasks will be modified to ensure no demand on the vergence system and no accommodative therapy is included in the placebo version. Please refer to the procedures manual for further details.

Placebo yoked prism flippers: Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5

Total of all reporting groups
Overall Number of Baseline Participants 75 85 44 204
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 85 participants 44 participants 204 participants
<=18 years
75
 100.0%
85
 100.0%
44
 100.0%
204
 100.0%
Between 18 and 65 years
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%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants 85 participants 44 participants 204 participants
12.2  (2.4) 12.6  (2.5) 12.3  (2.3) 12.4  (2.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 85 participants 44 participants 204 participants
Female
46
  61.3%
46
  54.1%
26
  59.1%
118
  57.8%
Male
29
  38.7%
39
  45.9%
18
  40.9%
86
  42.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 75 participants 85 participants 44 participants 204 participants
75 85 44 204
1.Primary Outcome
Title Treatment Group Comparison of the Percentage of Participants Classified as an Overall Success at 12 Weeks - HB-C Versus HB-PU
Hide Description

Pairwise treatment group comparison (HB-C versus HB-PU) of the percentages of participants meeting success criteria using binomial regression adjusting for baseline covariates of CISS score (<28 points vs ≥ 28 points), mean NPC break (<10 cm vs ≥ 10 cm), and mean PFV blur (≥ 15 PD vs <15 PD) using linear contrasts with Bonferroni adjustment for multiple comparisons (Type I error rate = 2.5%).

Overall success was defined as meeting all of the following criteria at 12 weeks:

  1. Convergence Insufficiency Symptom Survey (CISS): 12-week score <16 points and at least 9-point improvement from baseline at 12 weeks
  2. Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763 and a mean 12-week NPC break <6 cm
  3. Positive fusional vergence (PFV) blur: 12-week/baseline mean PFV blur >1.419 and a mean 12-week PFV break >15 pd
Time Frame 12 weeks after randomization (baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was limited to participants who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive).
Arm/Group Title Computer-based Therapy (CBT) Near Target Push-up (NTP) Placebo
Hide Arm/Group Description:
Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
Overall Number of Participants Analyzed 69 69 31
Measure Type: Count of Participants
Unit of Measure: Participants
16
  23.2%
15
  21.7%
5
  16.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Computer-based Therapy (CBT), Near Target Push-up (NTP)
Comments The primary outcome was success at 12 weeks. The sample size was computed to have 90% power to detect a treatment group difference between the HB-C versus HB-PU groups, assuming true population success percentages of 30% and 15% for the HB-C and HB-PU groups, respectively, with a type I error rate of 2.5%. The treatment group comparison was adjusted for baseline covariates of CISS score (<28 points vs ≥28 points), mean NPC break (<10 cm vs ≥10 cm) and mean PFV blur (≥15 pd vs <15 pd).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments Linear contrasts performed with a type I error rate of 2.5% based on a Bonferroni adjustment (overall type I error rate of 5% for 2 pairwise treatment group comparisons).
Method Biniomial regression
Comments Adjusted for baseline covariates of CISS score, mean NPC break and mean PFV blur. Linear contrasts performed with Bonferroni adjustment (alpha=0.025)
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -4
Confidence Interval (2-Sided) 97.5%
-19 to 11
Estimation Comments Negative values for the treatment group difference favor the HB-PU group. Results of the treatment group comparison are adjusted for baseline covariates of CISS, mean NPC break and mean PFV blur.
2.Primary Outcome
Title Treatment Group Comparison of the Percentage of Participants Classified as an Overall Success at 12 Weeks - HB-C Versus HB-P
Hide Description

Pairwise treatment group comparison (HB-C versus Placebo) of the percentages of participants meeting success criteria using binomial regression adjusting for baseline covariates of CISS score (<28 points vs ≥ 28 points), mean NPC break (<10 cm vs ≥ 10 cm), and mean PFV blur (≥ 15 PD vs <15 PD) using linear contrasts with Bonferroni adjustment for multiple comparisons.

Overall success was defined as meeting all of the following criteria at 12 weeks:

  1. Convergence Insufficiency Symptom Survey (CISS): 12-week score <16 points and at least 9-point improvement from baseline at 12 weeks
  2. Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763 and a mean 12-week NPC break <6 cm
  3. Positive fusional vergence (PFV) blur: 12-week/baseline mean PFV blur >1.419 and a mean 12-week PFV break >15 pd
Time Frame 12-weeks after randomization (baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was limited to participants who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive).
Arm/Group Title Computer-based Therapy (CBT) Near Target Push-up (NTP) Placebo
Hide Arm/Group Description:
Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
Overall Number of Participants Analyzed 69 69 31
Measure Type: Count of Participants
Unit of Measure: Participants
16
  23.2%
15
  21.7%
5
  16.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Computer-based Therapy (CBT), Placebo
Comments The primary outcome was success at 12 weeks. The sample size was computed to have 90% power to detect a treatment group difference between the HB-C versus HB-P groups, assuming true population success percentages of 30% and 10% for the HB-C and HB-PU groups, respectively, with a type I error rate of 2.5%. The treatment group comparison was adjusted for baseline covariates of CISS score (<28 points vs ≥28 points), mean NPC break (<10 cm vs ≥10 cm) and mean PFV blur (≥15 pd vs <15 pd).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments Linear contrasts performed with a type I error rate of 2.5% based on a Bonferroni adjustment (overall type I error rate of 5% for 2 pairwise treatment group comparisons).
Method Binomial regression
Comments Adjusted for baseline covariates of CISS score, mean NPC break and mean PFV blur. Linear contrasts performed with Bonferroni adjustment (alpha=0.025)
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 5
Confidence Interval (2-Sided) 97.5%
-12 to 22
Estimation Comments Positive values for the treatment group difference favor the HB-C group. Results of the treatment group comparison are adjusted for baseline covariates of CISS, mean NPC break and mean PFV blur.
3.Secondary Outcome
Title Number of Participants Classified as Having Met Success Criteria Based on CI Signs/Symptoms at 12 Weeks by Treatment Group
Hide Description The number of subjects classified as a success based on signs/symptoms at the 12-week visit. Success is based on the Convergency Insufficiency Symptom Survey (CISS) defined as improvement of 9 or more points from baseline and a 12-week score of <16 points.
Time Frame 12 weeks after randomization (baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was limited to participants who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.
Arm/Group Title Computer-based Therapy (CBT) Near Target Push-up (NTP) Placebo
Hide Arm/Group Description:
Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
Overall Number of Participants Analyzed 69 69 31
Measure Type: Number
Unit of Measure: participants
28 25 11
4.Secondary Outcome
Title Number of Participants Classified as Having Met Success Criteria Based on the Mean NPC Break at 12 Weeks by Treatment Group
Hide Description The number of subjects who are classified as a success based on the mean NPC break at the 12-week visit. Success is based on the mean NPC (near point of convergence) break is defined as having a mean NPC break of <6 cm at 12 weeks and a 12-week to baseline ratio of <0.763 for mean NPC break.
Time Frame 12 weeks after randomization (baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was limited to participants who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.
Arm/Group Title Computer-based Therapy (CBT) Near Target Push-up (NTP) Placebo
Hide Arm/Group Description:
Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
Overall Number of Participants Analyzed 69 69 31
Measure Type: Number
Unit of Measure: participants
33 33 11
5.Secondary Outcome
Title Number of Participants Classified as Having Met Success Criteria Based on the Mean PFV Blur at 12 Weeks by Treatment Group
Hide Description The number of subjects who are classified as a success based on the mean PFV blur at the 12-week visit. Success is based on the mean PFV (positive fusional vergence) blur, defined as having a mean PFV blur of >15 pd at 12 weeks and a 12-week to baseline ratio of >1.419 for mean PFV blur.
Time Frame 12 weeks after randomization (baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was limited to participants who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.
Arm/Group Title Computer-based Therapy (CBT) Near Target Push-up (NTP) Placebo
Hide Arm/Group Description:
Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
Overall Number of Participants Analyzed 69 69 69
Measure Type: Number
Unit of Measure: participants
49 35 16
6.Secondary Outcome
Title Number of Participants Classified as Having Met Success Criteria for Both Clinical Measures at 12 Weeks by Treatment Group
Hide Description

The number of subjects classified as a success based on clinical measures of CI (mean NPC break & mean PFV blur) at the 12-week visit. Clinical success is defined according to whether both criteria (below) are met as follows:

  1. Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763 and a 12-week mean NPC break <6 cm
  2. Positive fusional vergence (PFV) blur: 12-week/baseline mean PFV blur >1.419 and a 12-week mean PFV blur >15 pd
Time Frame 12-weeks after randomization (baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was limited to participants who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.
Arm/Group Title Computer-based Therapy (CBT) Near Target Push-up (NTP) Placebo
Hide Arm/Group Description:
Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
Overall Number of Participants Analyzed 69 69 31
Measure Type: Number
Unit of Measure: participants
30 22 9
7.Secondary Outcome
Title Number of Participants Classified as Having Improved in All 3 Outcomes Measures From Baseline to 12 Weeks by Treatment Group
Hide Description

Improvement in all 3 outcome measures at 12 weeks will be defined as follows:

  1. Convergency Insufficiency Symptom Survey (CISS): Improvement of 9 or more points since baseline
  2. Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763
  3. Positive fusional vergence (PFV) blur: 12-week/ baseline mean PFV blur >1.419

(Note: All 3 criteria must be met in order to be classified as an "improver" at the 12-week primary outcome visit).

Time Frame 12 weeks after randomization (baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was limited to participants who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.
Arm/Group Title Computer-based Therapy (CBT) Near Target Push-up (NTP) Placebo
Hide Arm/Group Description:
Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
Overall Number of Participants Analyzed 69 69 31
Measure Type: Number
Unit of Measure: participants
27 25 10
8.Secondary Outcome
Title Number of Participants Classified as an Overall Success Based on the 3 Outcomes Measures From Baseline to 6 Weeks by Treatment Group
Hide Description

To be considered an overall success, each of the following criteria must be met for the 3 outcome measures at 6 weeks:

  1. Convergence Insufficiency Symptom Survey (CISS): 6-week score <16 points and at least 9-point improvement from baseline at 6 weeks
  2. Near point of convergence (NPC) break: 6-week/baseline mean NPC break <0.763 and a mean 6-week NPC break <6 cm
  3. Positive fusional vergence (PFV) blur: 6-week/baseline mean PFV blur >1.419 and a mean 6-week PFV break >15 pd

(Note: All 3 criteria must be met in order to be classified as an overall success at the 6-week visit).

Time Frame 6 weeks after randomization (baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was limited to participants who completed the 6-week visit within the pre-specified analysis window (4 to <10 weeks). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.
Arm/Group Title Computer-based Therapy (CBT) Near Target Push-up (NTP) Placebo
Hide Arm/Group Description:
Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
Overall Number of Participants Analyzed 66 71 34
Measure Type: Number
Unit of Measure: participants
5 2 1
9.Secondary Outcome
Title Number of Participants Classified as Having Met Success Criteria Based on CI Signs/Symptoms at 6 Weeks by Treatment Group
Hide Description The number of subjects classified as a success based on signs/symptoms at the 6-week visit. Success is based on the Convergency Insufficiency Symptom Survey (CISS) defined as improvement of 9 or more points from baseline and a 6-week score of <16 points.
Time Frame 6 weeks after randomization (baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was limited to participants who completed the 6-week visit within the pre-specified analysis window (4 to <10 weeks). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.
Arm/Group Title Computer-based Therapy (CBT) Near Target Push-up (NTP) Placebo
Hide Arm/Group Description:
Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
Overall Number of Participants Analyzed 66 71 34
Measure Type: Number
Unit of Measure: participants
13 8 8
10.Secondary Outcome
Title Number of Participants Classified as Having Met Success Criteria Based on the Mean NPC Break at 6 Weeks by Treatment Group
Hide Description The number of subjects who are classified as a success based on the mean NPC break at the 6-week visit. Success is based on the mean NPC (near point of convergence) break is defined as having a mean NPC break of <6 cm at 6 weeks and a 6-week to baseline ratio of <0.763 for mean NPC break.
Time Frame 6 weeks after randomization (baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was limited to participants who completed the 6-week visit within the pre-specified analysis window (4 to <10 weeks). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.
Arm/Group Title Computer-based Therapy (CBT) Near Target Push-up (NTP) Placebo
Hide Arm/Group Description:
Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
Overall Number of Participants Analyzed 66 71 34
Measure Type: Number
Unit of Measure: participants
24 20 5
11.Secondary Outcome
Title Number of Participants Classified as Having Met Success Criteria Based on the Mean PFV Blur at 6 Weeks by Treatment Group
Hide Description The number of subjects who are classified as a success based on the mean PFV blur at the 6-week visit. Success is based on the mean PFV (positive fusional vergence) blur, defined as having a mean PFV blur of >15 pd at 6 weeks and a 6-week to baseline ratio of >1.419 for mean PFV blur.
Time Frame 6 weeks after randomization (baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was limited to participants who completed the 6-week visit within the pre-specified analysis window (4 to <10 weeks). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.
Arm/Group Title Computer-based Therapy (CBT) Near Target Push-up (NTP) Placebo
Hide Arm/Group Description:
Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
Overall Number of Participants Analyzed 66 71 34
Measure Type: Number
Unit of Measure: participants
38 23 12
12.Secondary Outcome
Title Number of Participants Classified as Having Met Success Criteria for Both Clinical Measures at 6 Weeks by Treatment Group
Hide Description

The number of subjects classified as a success based on clinical measures of CI (mean NPC break & mean PFV blur) at the 6-week visit. Clinical success is defined according to whether both criteria (below) are met as follows:

  1. Near point of convergence (NPC) break: 6-week/baseline mean NPC break <0.763 and a 6-week mean NPC break <6 cm
  2. Positive fusional vergence (PFV) blur: 6-week/baseline mean PFV blur >1.419 and a 6-week mean PFV blur >15 pd
Time Frame 6-weeks after randomization (baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was limited to participants who completed the 6-week visit within the pre-specified analysis window (4 to <10 weeks). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.
Arm/Group Title Computer-based Therapy (CBT) Near Target Push-up (NTP) Placebo
Hide Arm/Group Description:
Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
Overall Number of Participants Analyzed 66 71 34
Measure Type: Number
Unit of Measure: participants
20 10 3
13.Secondary Outcome
Title Number of Participants Classified as Having Improved in All 3 Outcomes Measures From Baseline to 6 Weeks by Treatment Group
Hide Description

Improvement in all 3 outcome measures at 6 weeks will be defined as follows:

  1. Convergency Insufficiency Symptom Survey (CISS): Improvement of 9 or more points since baseline
  2. Near point of convergence (NPC) break: 6-week/baseline mean NPC break <0.763
  3. Positive fusional vergence (PFV) blur: 6-week/baseline mean PFV blur >1.419

(Note: All 3 criteria must be met in order to be classified as an "improver" at the 6-week visit).

Time Frame 6 weeks after randomization (baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was limited to participants who completed the 6-week visit within the pre-specified analysis window (4 to <10 weeks). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.
Arm/Group Title Computer-based Therapy (CBT) Near Target Push-up (NTP) Placebo
Hide Arm/Group Description:
Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
Overall Number of Participants Analyzed 66 71 34
Measure Type: Number
Unit of Measure: participants
17 13 3
14.Post-Hoc Outcome
Title Number of Participants Classified as an Overall Success at 12 Weeks in the HB-C Group According to Whether or Not the Computer-based Therapy Program Was Completed at 12 Weeks
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This outcome was limited to participants randomly assigned to the HB-C group.

Completion of the home-based computer therapy program was defined as achieving at least 15 stars on the jump vergence therapy).

Overall success was defined as meeting the following criteria for all 3 outcome measures at 12 weeks:

  1. Convergence Insufficiency Symptom Survey (CISS): 12-week score of <16 points and at least a 9-point improvement from baseline at 12 weeks
  2. Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763 and a 12-week mean NPC break <6 cm
  3. Positive fusional vergence (PFV) blur: 12-week/ baseline mean PFV blur > 1.419 and a 12-week mean PFV blur >15 pd
Time Frame 12 weeks after randomization (baseline)
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Hide Analysis Population Description
The analysis was limited to participants who were randomly assigned to the HB-C group who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive).
Arm/Group Title HB-C (Completed Computer-based Therapy Program) HB-C (Did Not Complete Computer-based Therapy Program)
Hide Arm/Group Description:
Participants in the HB-C treatment group who completed the computer vergence/accommodative therapy (CVAT) program at 12 weeks, defined as achieving at least 15 stars for the jump vergence exercise).
Participants in the HB-C treatment group who did not complete the computer vergence/accommodative therapy (CVAT) program at 12 weeks, defined as achieving <15 stars for the jump vergence exercise.
Overall Number of Participants Analyzed 22 47
Measure Type: Number
Unit of Measure: participants
4 12
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HB-C (Completed Computer-based Therapy Program)
Comments For the HB-C group, the association between completion of the computer vergence/accommodative therapy (CVAT) program (defined as achieving at least 15 stars for the jump vergence exercise) and overall success at 12 weeks was evaluated using Bernard's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Bernard's exact test
Comments A p-value was not reported in the manuscript results, but has been included here, reported directly from the analysis.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -7
Confidence Interval (2-Sided) 95%
-27 to 17
Estimation Comments [Not Specified]
Time Frame 12 week primary outcome.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Computer-based Therapy (CBT) Near Target Push-up (NTP) Placebo
Hide Arm/Group Description Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home. Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home. Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
All-Cause Mortality
Computer-based Therapy (CBT) Near Target Push-up (NTP) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Computer-based Therapy (CBT) Near Target Push-up (NTP) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/75 (0.00%)   0/85 (0.00%)   0/44 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Computer-based Therapy (CBT) Near Target Push-up (NTP) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/75 (0.00%)   0/85 (0.00%)   0/44 (0.00%) 

Differential loss to follow-up (HB-C 8%, HB-PU 19%, and HB-P 30%).

Did not formally assess whether participants remained masked to their treatment group during the study.

Assessment of compliance was not completely objective.

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
Layout table for additonal information
Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT01515943    
Other Study ID Numbers: CITS
2U10EY011751 ( U.S. NIH Grant/Contract )
First Submitted: January 19, 2012
First Posted: January 24, 2012
Results First Submitted: May 2, 2016
Results First Posted: August 5, 2016
Last Update Posted: April 12, 2017