Correction of Myopia Evaluation Trial 2

NCT00320593 | Completed Phase 3 Results DMC

• 3 other identifiers: NEI-1232U10EY0117515U10EY011751
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 8

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.

Conditions

Myopia

Keywords

Myopia; Progressive Addition Lenses (PALs); Single Vision Lenses (SVLs); Accommodative lags; Near esophoria; Refractive error

Outcome Measures

Primary Outcomes (2)

• Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years

  Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is the sphere plus 1/2 the cylinder. For baseline and each time point, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.

  Baseline to 3 years

• Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years

  Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and each time point, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.

  3 years

Secondary Outcomes (7)

• Distribution of Spherical Equivalent Refractive Error at 3 Years

  3 years

• Mean Spherical Equivalent Refractive Error at 3 Years

  3 years

• Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics

  Baseline to 3 years

• Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics

  Baseline to 3 years

• Mean Change in Spherical Equivalent Refractive Error From Baseline to 1 Year

  Baseline to 1 year

Study Arms (2)

Progressive addition lenses (PALs)

ACTIVE COMPARATOR

Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition

Device: Progressive Addition Lenses (PALs)

Single vision lenses (SVLs)

ACTIVE COMPARATOR

Single vision lenses

Device: Single Vision Lenses (SVLs)

Interventions

Progressive Addition Lenses (PALs) DEVICE

Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition

Progressive addition lenses (PALs)

Single Vision Lenses (SVLs) DEVICE

Single vision lenses

Single vision lenses (SVLs)

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Refractive error determined by cycloplegic autorefraction which meets all of the following:
• Spherical equivalent: -0.50 to -3.00 D in both eyes
• Astigmatism \<= 1.5 D in both eyes
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• National Eye Institute (NEI): collaborator

Study Sites (8)

University of Alabama- Birmingham, School of Optometry

Birmingham, Alabama, 35294, United States

Location

Southern California College of Optometry

Fullerton, California, 92831-1699, United States

Location

Indiana School of Optometry

Bloomington, Indiana, 47405, United States

Location

New England College of Optometry

Boston, Massachusetts, 02215-3468, United States

Location

Ohio State University College of Optometry

Columbus, Ohio, 43210-1280, United States

Location

Family Eye Group

Lancaster, Pennsylvania, 17601, United States

Location

Pennsylvania College of Optometry

Philadelphia, Pennsylvania, 19141, United States

Location

University of Houston College of Optometry

Houston, Texas, 77204-2020, United States

Location

Related Publications (3)

• 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.

  PMID: 19214130 RESULT

• 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.

  PMID: 21282579 RESULT

• 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.

  PMID: 36809645 DERIVED

MeSH Terms

Conditions

Myopia; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Raymond Kraker, MSPH
• Organization: Jaeb Center for Health Research

pedig@jaeb.org

813-875-8690

Study Officials

• Jane E Gwiazda, Ph.D.

  New England College of Optometry

  STUDY CHAIR

• Wendy L Marsh-Tootle

  University of Alabama at Birmingham School of Optometry

  PRINCIPAL INVESTIGATOR

• Ruth E Manny

  University of Houston College of Optometry

  PRINCIPAL INVESTIGATOR

• Erik M Weissberg

  New England College of Optometry

  PRINCIPAL INVESTIGATOR

• David I Silbert

  Family Eye Group

  PRINCIPAL INVESTIGATOR

• Don W Lyon

  Indiana University

  PRINCIPAL INVESTIGATOR

• Mitchell M Scheiman

  Pennsylvania College of Optometry

  PRINCIPAL INVESTIGATOR

• Marjean T Kulp

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Susan A Cotter

  Southern California College of Optometry at Marshall B. Ketchum University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2006
• First Posted: May 3, 2006
• Study Start: April 1, 2005
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: July 19, 2016
• Results First Posted: June 21, 2011

Record last verified: 2016-07

Locations

US (8)