Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
118 participants
INTERVENTIONAL
2005-04-30
2010-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Progressive addition lenses (PALs)
Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
Progressive Addition Lenses (PALs)
Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
Single vision lenses (SVLs)
Single vision lenses
Single Vision Lenses (SVLs)
Single vision lenses
Interventions
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Progressive Addition Lenses (PALs)
Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
Single Vision Lenses (SVLs)
Single vision lenses
Eligibility Criteria
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Inclusion Criteria
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
* Current or prior use of PALs, bifocals, or contact lenses in either eye (prior or current use of SVLs is allowed)
8 Years
11 Years
ALL
No
Sponsors
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National Eye Institute (NEI)
NIH
Jaeb Center for Health Research
OTHER
Responsible Party
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Principal Investigators
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Jane E Gwiazda, Ph.D.
Role: STUDY_CHAIR
New England College of Optometry
Wendy L Marsh-Tootle
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham School of Optometry
Ruth E Manny
Role: PRINCIPAL_INVESTIGATOR
University of Houston College of Optometry
Erik M Weissberg
Role: PRINCIPAL_INVESTIGATOR
New England College of Optometry
David I Silbert
Role: PRINCIPAL_INVESTIGATOR
Family Eye Group
Don W Lyon
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Mitchell M Scheiman
Role: PRINCIPAL_INVESTIGATOR
Pennsylvania College of Optometry
Marjean T Kulp
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Susan A Cotter
Role: PRINCIPAL_INVESTIGATOR
Southern California College of Optometry at Marshall B. Ketchum University
Locations
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University of Alabama- Birmingham, School of Optometry
Birmingham, Alabama, United States
Southern California College of Optometry
Fullerton, California, United States
Indiana School of Optometry
Bloomington, Indiana, United States
New England College of Optometry
Boston, Massachusetts, United States
Ohio State University College of Optometry
Columbus, Ohio, United States
Family Eye Group
Lancaster, Pennsylvania, United States
Pennsylvania College of Optometry
Philadelphia, Pennsylvania, United States
University of Houston College of Optometry
Houston, Texas, United States
Countries
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References
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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.
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.
Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.
Other Identifiers
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