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Correction of Myopia Evaluation Trial 2 (COMET2)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT00320593
First received: April 28, 2006
Last updated: January 25, 2012
Last verified: January 2012
Results First Received: May 17, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Myopia
Interventions: Device: Progressive Addition Lenses (PALs)
Device: Single Vision Lenses (SVLs)

  Participant Flow
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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
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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  
Number of Participants  
[units: participants]
  59     59     118  
Age [1]
[units: years]
Mean ± Standard Deviation
  10.2  ± 1.1     10.0  ± 1.1     10.1  ± 1.1  
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  
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 [2]
[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  
Average Spherical Equivalent Between the Eyes [3]
[units: diopters]
Mean ± Standard Deviation
  -1.50  ± 0.45     -1.45  ± 0.47     -1.48  ± 0.46  
Average J0 Between the Eyes [4]
[units: diopters]
Mean ± Standard Deviation
  -0.02  ± 0.18     -0.02  ± 0.15     -0.02  ± 0.16  
Average J45 Between the Eyes [5]
[units: diopters]
Mean ± Standard Deviation
  0.11  ± 0.07     0.10  ± 0.07     0.11  ± 0.07  
Anisometropia [6]
[units: diopters]
Mean ± Standard Deviation
  0.22  ± 0.20     0.21  ± 0.16     0.22  ± 0.18  
Near Esophoria [7]
[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  
Near Esophoria [7]
[units: prism┬ádiopters]
Mean ± Standard Deviation
  5.8  ± 3.2     5.9  ± 3.4     5.9  ± 3.3  
Accommodative Lag [8]
[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  
Accommodative Lag [8]
[units: diopters]
Mean ± Standard Deviation
  1.47  ± 0.53     1.40  ± 0.48     1.44  ± 0.50  
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  
[1] Age at enrollment
[2] 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.
[3] 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.
[4] 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.
[5] 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.
[6] 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.
[7] 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.
[8] 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.



  Outcome Measures
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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
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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
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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:
Other Publications:

Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00320593     History of Changes
Other Study ID Numbers: NEI-123, 2U10EY011751, 5U10EY011751
Study First Received: April 28, 2006
Results First Received: May 17, 2011
Last Updated: January 25, 2012
Health Authority: United States: Federal Government