Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Correction of Myopia Evaluation Trial 2 (COMET2)

This study has been completed.
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT00320593
First received: April 28, 2006
Last updated: July 15, 2016
Last verified: July 2016
Results First Received: May 17, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Myopia
Interventions: Device: Progressive Addition Lenses (PALs)
Device: Single Vision Lenses (SVLs)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between April 2005 and March 2007, 118 subjects age 8 to <12 years were enrolled in the study at 8 clinical centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Progressive Addition Lenses (PALs) Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
Single Vision Lenses (SVLs) Standard single vision lenses

Participant Flow:   Overall Study
    Progressive Addition Lenses (PALs)   Single Vision Lenses (SVLs)
STARTED   59   59 
COMPLETED   52 [1]   58 [1] 
NOT COMPLETED   7   1 
Lost to Follow-up                3                0 
Moved to another state                1                0 
Withdrawal by Subject                2                1 
Withdrawal by clinical center                1                0 
[1] Completed defined as completing the 3 year primary outcome exam



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Progressive Addition Lenses (PALs) Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
Single Vision Lenses (SVLs) Standard single vision lenses
Total Total of all reporting groups

Baseline Measures
   Progressive Addition Lenses (PALs)   Single Vision Lenses (SVLs)   Total 
Overall Participants Analyzed 
[Units: Participants]
 59   59   118 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 10.2  (1.1)   10.0  (1.1)   10.1  (1.1) 
[1] Age at enrollment
Age, Customized [1] 
[Units: Participants]
     
8 to <9 years   8   14   22 
9 to <10 years   15   17   32 
10 to <11 years   18   14   32 
11 to <12 years   18   14   32 
[1] Age at enrollment
Gender 
[Units: Participants]
     
Female   36   28   64 
Male   23   31   54 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   28   31   59 
African American   14   10   24 
Hispanic or Latino   10   12   22 
Asian   5   4   9 
Other   2   2   4 
Region of Enrollment 
[Units: Participants]
     
United States   59   59   118 
Spectacle wear (single vision lenses) 
[Units: Participants]
     
Currently   33   33   66 
In past but not currently   4   2   6 
Never   22   24   46 
Average Spherical Equivalent Between the Eyes [1] 
[Units: Participants]
     
-0.75 to -0.99 diopters (D)   8   12   20 
-1.00 to -1.49 D   22   23   45 
-1.50 to -1.99 D   18   14   32 
-2.00 to -2.50 D   11   10   21 
[1] Measured in diopters (D) using cycloplegic refraction sphere, cylinder and axis. In this study, sphere refers to the amount of myopia (nearsightedness) and cylinder the amount of astigmatism at a particular angle from 0 to 180 degrees (axis). Spherical equivalent is defined as the sphere plus 1/2 the cylinder. A spherical equivalent was calculated for each eye for each of the five trials of cycloplegic autorefraction, and the median for each eye was averaged to obtain the spherical equivalent used for analysis.
Average Spherical Equivalent Between the Eyes [1] 
[Units: Diopters]
Mean (Standard Deviation)
 -1.50  (0.45)   -1.45  (0.47)   -1.48  (0.46) 
[1] Measured in diopters (D) using cycloplegic refraction sphere, cylinder, and axis. In this study, sphere refers to the amount of myopia (nearsightedness) and cylinder the amount of astigmatism at a particular angle from 0 to 180 degrees (axis). Spherical equivalent is defined as the sphere plus 1/2 the cylinder. A spherical equivalent was calculated for each eye for each of the five trials of cycloplegic autorefraction, and the median for each eye was averaged to obtain the spherical equivalent used for analysis.
Average J0 Between the Eyes [1] 
[Units: Diopters]
Mean (Standard Deviation)
 -0.02  (0.18)   -0.02  (0.15)   -0.02  (0.16) 
[1] Measured in diopters (D) using cycloplegic refraction sphere, cylinder, and axis. In this study, sphere refers to the amount of myopia (nearsightedness) and cylinder the amount of astigmatism at a particular angle from 0 to 180 degrees (axis). The dioptric power of a Jackson cross cylinder with axis at 0 degrees (J0) is calculated using the power vector approach. A J0 was calculated for each eye for each of the five trials of cycloplegic autorefraction, and the median for each eye was averaged to obtain the J0 used for analysis.
Average J45 Between the Eyes [1] 
[Units: Diopters]
Mean (Standard Deviation)
 0.11  (0.07)   0.10  (0.07)   0.11  (0.07) 
[1] Measured in diopters (D) using cycloplegic refraction sphere, cylinder, and axis. In this study, sphere refers to the amount of myopia (nearsightedness) and cylinder the amount of astigmatism at a particular angle from 0 to 180 degrees (axis). The dioptric power of a Jackson cross cylinder with axis at 45 degrees (J45) is calculated using the power vector approach. A J45 was calculated for each eye for each of the five trials of cycloplegic autorefraction, and the median for each eye was averaged to obtain the J45 used for analysis.
Anisometropia [1] 
[Units: Diopters]
Mean (Standard Deviation)
 0.22  (0.20)   0.21  (0.16)   0.22  (0.18) 
[1] Measured in diopters (D) using cycloplegic refraction sphere, cylinder, and axis. In this study, sphere refers to the amount of myopia (nearsightedness) and cylinder the amount of astigmatism at a particular angle from 0 to 180 degrees (axis). Anisometropia is defined as spherical equivalent in the right eye subtracted by spherical equivalent in the left eye.
Near Esophoria [1] 
[Units: Participants]
     
2 to 5 prism diopters (PD)   33   34   67 
6 to 10 PD   22   21   43 
11 to 15 PD   3   3   6 
16 to 20 PD   1   1   2 
[1] Measured in prism diopters (PD) using the Prism and Alternate Cover Test (PACT) at 33 cm. Esophoria is the tendency of the eyes to deviate inwards when fusion between the eyes is suspended. Near esophoria is an esophoria when viewing close objects.
Near Esophoria [1] 
[Units: Prism diopters]
Mean (Standard Deviation)
 5.8  (3.2)   5.9  (3.4)   5.9  (3.3) 
[1] Measured in prism diopters (PD) using the Prism and Alternate Cover Test (PACT) at 33 cm. Esophoria is the tendency of the eyes to deviate inwards when fusion between the eyes is suspended. Near esophoria is an esophoria when viewing close objects.
Accommodative Lag [1] 
[Units: Participants]
     
0.50 to 0.99 diopters (D)   8   6   14 
1.00 to 1.49 D   26   33   59 
1.50 to 1.99 D   13   16   29 
2.00 D or more   12   4   16 
[1] Measured in diopters (D) using cycloplegic refraction sphere, cylinder, and axis. Sphere refers to the amount of myopia (nearsightedness) and cylinder the amount of astigmatism at a particular angle (axis). Accommodative lag is the average of the median accommodative lag of the five trials of the right eye. To determine the accommodative lag or accommodative lead, the accommodative measurement was added to the 3.00-D demand to result in the accommodative lag or lead. If the value was positive, it indicated accommodative lag; if the number was negative, it indicated accommodative lead.
Accommodative Lag [1] 
[Units: Diopters]
Mean (Standard Deviation)
 1.47  (0.53)   1.40  (0.48)   1.44  (0.50) 
[1] Measured in diopters (D) using cycloplegic refraction sphere, cylinder, and axis. Sphere refers to the amount of myopia (nearsightedness) and cylinder the amount of astigmatism at a particular angle (axis). Accommodative lag is the average of the median accommodative lag of the five trials of the right eye. To determine the accommodative lag or accommodative lead, the accommodative measurement was added to the 3.00-D demand to result in the accommodative lag or lead. If the value was positive, it indicated accommodative lag; if the number was negative, it indicated accommodative lead.
Parental History of Myopia 
[Units: Participants]
     
Neither parent   10   5   15 
One parent   16   10   26 
Both parents   18   20   38 
Missing/unknown   15   24   39 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years   [ Time Frame: Baseline to 3 years ]

2.  Primary:   Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years   [ Time Frame: 3 years ]

3.  Secondary:   Distribution of Spherical Equivalent Refractive Error at 3 Years   [ Time Frame: 3 years ]

4.  Secondary:   Mean Spherical Equivalent Refractive Error at 3 Years   [ Time Frame: 3 years ]

5.  Secondary:   Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics   [ Time Frame: Baseline to 3 years ]

6.  Secondary:   Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics   [ Time Frame: Baseline to 3 years ]

7.  Secondary:   Mean Change in Spherical Equivalent Refractive Error From Baseline to 1 Year   [ Time Frame: Baseline to 1 year ]

8.  Secondary:   Mean Change in Spherical Equivalent Refractive Error From Baseline to 2 Years   [ Time Frame: Baseline to 2 years ]

9.  Secondary:   Excellent Spectacle Compliance   [ Time Frame: Baseline to 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitations include: differential loss to follow up , differential compliance between the groups, power of near addition was not customized in PAL group, and we have no data on whether PAL group was looking through the near addition.


  More Information
  Hide More Information

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:  
Name/Title: Raymond Kraker, MSPH
Organization: Jaeb Center for Health Research
phone: 813-875-8690
e-mail: pedig@jaeb.org


Publications of Results:

Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00320593     History of Changes
Other Study ID Numbers: NEI-123
2U10EY011751 ( US NIH Grant/Contract Award Number )
5U10EY011751 ( US NIH Grant/Contract Award Number )
Study First Received: April 28, 2006
Results First Received: May 17, 2011
Last Updated: July 15, 2016