Phase 3
N=118
Correction of Myopia Evaluation Trial 2
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT00320593 ↗Enrolled (actual)
118
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcome: Primary: Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years — 6; 3; 11; 8 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Progressive Addition Lenses (PALs) (Device); Single Vision Lenses (SVLs) (Device)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- Jaeb Center for Health Research
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years |
6; 3; 11; 8; 16; 13 | — |
| PRIMARY Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years |
-0.87; -1.15 | — |
| SECONDARY Distribution of Spherical Equivalent Refractive Error at 3 Years |
0; 1; 2; 1; 18; 14 | — |
| SECONDARY Mean Spherical Equivalent Refractive Error at 3 Years |
-2.41; -2.60 | — |
| SECONDARY Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics |
8; 13; 13; 17; 15; 14 | — |
| SECONDARY Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics |
-1.23; -1.39; -1.11; -1.14; -0.71; -1.19 | — |
| SECONDARY Mean Change in Spherical Equivalent Refractive Error From Baseline to 1 Year |
-0.29; -0.42 | — |
| SECONDARY Mean Change in Spherical Equivalent Refractive Error From Baseline to 2 Years |
-0.58; -0.80 | — |
| SECONDARY Excellent Spectacle Compliance |
72; 90; 60; 76; 60; 71 | — |
Summary
The purpose of the study is to determine if progressive addition lenses (PALs) versus single vision lenses (SVLs) slow the progression of low myopia in children with poor accommodative responses (i.e., large accommodative lags) and near esophoria.
Eligibility Criteria
Inclusion Criteria
- Refractive error determined by cycloplegic autorefraction which meets all of the following:
- Spherical equivalent: -0.50 to -3.00 D in both eyes
- Astigmatism = 2.0 PD) present by alternate prism and cover test (APCT) at near using best refractive correction determined from non-cycloplegic subjective refraction
Exclusion Criteria
- Strabismus present by cover-uncover test at far, near, and/or near with +2.00D over best subjective refraction
- Current or prior use of PALs, bifocals, or contact lenses in either eye (prior or current use of SVLs is allowed)
Data sourced from ClinicalTrials.gov (NCT00320593). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.