NCT00000113

Brief Summary

To evaluate whether progressive addition lenses (PALs) slow the rate of progression of juvenile-onset myopia (nearsightedness) when compared with single vision lenses, as measured by cycloplegic autorefraction. An additional outcome measure is axial length, as measured by A-scan ultrasonography. To describe the natural history of juvenile-onset myopia in a group of children receiving conventional treatment (single vision lenses).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
469

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 1997

Longer than P75 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1997

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 23, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 1999

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2001

Completed
11.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

April 15, 2016

Status Verified

April 1, 2016

Enrollment Period

4.1 years

First QC Date

September 23, 1999

Last Update Submit

April 14, 2016

Conditions

Myopia

Keywords

myopianearsightedness

Outcome Measures

Primary Outcomes (1)

  • Progression of myopia, determined by cycloplegic autorefraction

Secondary Outcomes (1)

  • Axial length measured by A-scan ultrasonography

Study Arms (2)

Progressive Addition Lenses (PALs)

EXPERIMENTAL
Other: Progressive Addition Lenses

Single Vision Lenses

ACTIVE COMPARATOR
Other: single vision lenses

Interventions

Progressive Addition LensesOTHER

Varilux comfort with +2.00 addition

Progressive Addition Lenses (PALs)
single vision lensesOTHER
Single Vision Lenses

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Alabama-Birmingham, School of Optometry

Birmingham, Alabama, 35294-0010, United States

Location

New England College of Optometry

Boston, Massachusetts, 02115, United States

Location

Pennsylvania College of Optometry

Philadelphia, Pennsylvania, 19141-3399, United States

Location

University of Houston, College of Optometry

Houston, Texas, 77204-6052, United States

Location

Related Publications (6)

  • Gwiazda J, Hyman L, Hussein M, Everett D, Norton TT, Kurtz D, Leske MC, Manny R, Marsh-Tootle W, Scheiman M. A randomized clinical trial of progressive addition lenses versus single vision lenses on the progression of myopia in children. Invest Ophthalmol Vis Sci. 2003 Apr;44(4):1492-500. doi: 10.1167/iovs.02-0816.

    PMID: 12657584RESULT

  • Gwiazda JE, Hyman L, Norton TT, Hussein ME, Marsh-Tootle W, Manny R, Wang Y, Everett D; COMET Grouup. Accommodation and related risk factors associated with myopia progression and their interaction with treatment in COMET children. Invest Ophthalmol Vis Sci. 2004 Jul;45(7):2143-51. doi: 10.1167/iovs.03-1306.

    PMID: 15223788RESULT

  • Hyman L, Gwiazda J, Hussein M, Norton TT, Wang Y, Marsh-Tootle W, Everett D. Relationship of age, sex, and ethnicity with myopia progression and axial elongation in the correction of myopia evaluation trial. Arch Ophthalmol. 2005 Jul;123(7):977-87. doi: 10.1001/archopht.123.7.977.

    PMID: 16009841RESULT

  • 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: 36809645DERIVED

  • Deng L, Gwiazda J, Manny RE, Scheiman M, Weissberg E, Fern KD, Weise K; COMET Study Group. Limited change in anisometropia and aniso-axial length over 13 years in myopic children enrolled in the Correction of Myopia Evaluation Trial. Invest Ophthalmol Vis Sci. 2014 Apr 3;55(4):2097-105. doi: 10.1167/iovs.13-13675.

    PMID: 24576881DERIVED

  • Gwiazda J, Deng L, Manny R, Norton TT; COMET Study Group. Seasonal variations in the progression of myopia in children enrolled in the correction of myopia evaluation trial. Invest Ophthalmol Vis Sci. 2014 Feb 4;55(2):752-8. doi: 10.1167/iovs.13-13029.

    PMID: 24408976DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Jane Gwiazda, PhD

    New England College of Optometry

    STUDY CHAIR

  • Leslie Hyman, PhD

    Stony Brook Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 23, 1999

First Posted

September 24, 1999

Study Start

September 1, 1997

Primary Completion

October 1, 2001

Study Completion

September 1, 2013

Last Updated

April 15, 2016

Record last verified: 2016-04

Locations

US(4)