Clinical trial NCT00320593: Correction of Myopia Evaluation Trial 2
Official title: Correction of Myopia Evaluation Trial 2 (COMET2): A Randomized Trial of the Effect of Progressive Addition Lenses Versus Single Vision Lenses on Low Myopia Associated With Large Accommodative Lags and Near Esophoria in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myopia
Keywords: Myopia
Progressive Addition Lenses (PALs)
Single Vision Lenses (SVLs)
Accommodative lags
Near esophoria
Refractive error
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2006-05-03
Enrollment: 118
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Myopia is a significant public health problem that affects at least 34% of children in the United States and a much higher percentage in Asia. It is a predisposing factor for retinal detachment, myopic retinopathy, and glaucoma, thus contributing to loss of vision and blindness. As might be expected for such a prevalent condition, treatment costs are high. If interventions to retard myopia progression are successful, sight-threatening complications might be avoided and costs should be reduced.

The study has been designed as a simple trial that, other than the type of lenses being determined through the randomization process and the addition of accommodation testing using an autorefractor, largely approximates standard clinical practice.

Screening consists of non-cycloplegic procedures of subjective refraction, testing of oculomotor alignment, and testing of accommodative response using the Grand Seiko autorefractor.

Patients who appear to be eligible for the randomized trial will be tested with their eyes dilated to determine whether refractive error in each eye is within the eligibility range for the randomized trial. Patients will be randomized to either progressive addition lenses (PALs) with a +2.00 D addition or to single vision lenses (SVLs). Children will have three years of follow up, with visits every 6 months.

The primary outcome visit is timed 3 years from randomization, with the primary analysis being a comparison of the average change from baseline to 3 years in amount of myopia between children in the single-vision lens group and the children in the progressive-addition lens group. The primary outcome is change in spherical equivalent refractive error (SER) in diopters (D) as measured by cycloplegic autorefraction.

A separate ancillary study nested within the screening process will collect data on two additional methods of measuring accommodation, Monocular Estimate Method (MEM) retinoscopy and Nott retinoscopy. The aim of the ancillary study to help determine whether a simple, effective measure exists that can be easily used by clinicians to identify children with reduced accommodative response who, if they have low myopia and esophoria, might benefit from the treatment with PALs.

Eligibility criteria: Inclusion Criteria:

* Refractive error determined by cycloplegic autorefraction which meets all of the following:

  1. Spherical equivalent: -0.50 to -3.00 D in both eyes
  2. Astigmatism \<= 1.5 D in both eyes
  3. Anisometropia \<= 1.00 D difference between eyes in spherical equivalent
* Visual acuity is at least 20/20 with best subjective refraction in both eyes
* Accommodative response at near (33 cm) is less than 2.0D by non-cycloplegic autorefraction
* Near esophoria (\>= 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)

Primary outcomes:
measure: Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years
timeFrame: Baseline to 3 years
measure: Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years
timeFrame: 3 years
Secondary outcomes:
measure: Distribution of Spherical Equivalent Refractive Error at 3 Years
timeFrame: 3 years
measure: Mean Spherical Equivalent Refractive Error at 3 Years
timeFrame: 3 years
measure: Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics
timeFrame: Baseline to 3 years
measure: Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics
timeFrame: Baseline to 3 years
measure: Mean Change in Spherical Equivalent Refractive Error From Baseline to 1 Year
timeFrame: Baseline to 1 year
measure: Mean Change in Spherical Equivalent Refractive Error From Baseline to 2 Years
timeFrame: Baseline to 2 years
measure: Excellent Spectacle Compliance
timeFrame: Baseline to 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama- Birmingham, School of Optometry
state: Alabama
city: Fullerton
country: United States
facility: Southern California College of Optometry
state: California
city: Bloomington
country: United States
facility: Indiana School of Optometry
state: Indiana
city: Boston
country: United States
facility: New England College of Optometry
state: Massachusetts
city: Columbus
country: United States
facility: Ohio State University College of Optometry
state: Ohio
city: Lancaster
country: United States
facility: Family Eye Group
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania College of Optometry
state: Pennsylvania
city: Houston
country: United States
facility: University of Houston College of Optometry
state: Texas
Study officials:
affiliation: New England College of Optometry
name: Jane E Gwiazda, Ph.D.
role: STUDY_CHAIR
affiliation: University of Alabama at Birmingham School of Optometry
name: Wendy L Marsh-Tootle
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Houston College of Optometry
name: Ruth E Manny
role: PRINCIPAL_INVESTIGATOR
affiliation: New England College of Optometry
name: Erik M Weissberg
role: PRINCIPAL_INVESTIGATOR
affiliation: Family Eye Group
name: David I Silbert
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: Don W Lyon
role: PRINCIPAL_INVESTIGATOR
affiliation: Pennsylvania College of Optometry
name: Mitchell M Scheiman
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Marjean T Kulp
role: PRINCIPAL_INVESTIGATOR
affiliation: Southern California College of Optometry at Marshall B. Ketchum University
name: Susan A Cotter
role: PRINCIPAL_INVESTIGATOR
References:
citation: Correction of Myopia Evaluation Trial 2 Study Group for the Pediatric Eye Disease Investigator Group; Manny RE, Chandler DL, Scheiman MM, Gwiazda JE, Cotter SA, Everett DF, Holmes JM, Hyman LG, Kulp MT, Lyon DW, Marsh-Tootle W, Matta N, Melia BM, Norton TT, Repka MX, Silbert DI, Weissberg EM. Accommodative lag by autorefraction and two dynamic retinoscopy methods. Optom Vis Sci. 2009 Mar;86(3):233-43. doi: 10.1097/OPX.0b013e318197180c.
citation: Correction of Myopia Evaluation Trial 2 Study Group for the Pediatric Eye Disease Investigator Group. Progressive-addition lenses versus single-vision lenses for slowing progression of myopia in children with high accommodative lag and near esophoria. Invest Ophthalmol Vis Sci. 2011 Apr 25;52(5):2749-57. doi: 10.1167/iovs.10-6631.