NCT00000128

Brief Summary

To test the hypothesis that correction with bifocal spectacle lenses rather than single-vision lenses will slow the progression of myopia in children with near-point esophoria. The primary outcome variable is cycloplegic refraction as measured with an automated refractor. Axial length is measured with ultrasound in order to test the corollary hypothesis that use of bifocals will slow ocular growth in these myopic children. We will also examine the amount of close work performed by subjects and the degree of parental myopia as factors that may influence myopia progression.

Trial Health

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1996

Completed
3.3 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
Last Updated

June 24, 2005

Status Verified

June 1, 2002

First QC Date

September 23, 1999

Last Update Submit

June 23, 2005

Conditions

MyopiaStrabismusEsophoria

Keywords

Near-point Esophoria

Interventions

Bifocal Spectacle LensesDEVICE

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Age GroupsChild (0-17)
Boys must have been between 6 and 12 years of age; girls between 6 and 11 years of age. All children must have had at least 0.5 diopters of myopia in both eyes, near-point esophoria, at least 20/25 acuity in each eye, and 40 seconds of stereopsis and must have been free of ocular disease or systemic disease that may have altered refraction. All subjects were willing to wear bifocal spectacle lenses for 30 months.

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Sponsors & Collaborators

Related Publications (4)

  • Fulk GW, Cyert LA. Can bifocals slow myopia progression? J Am Optom Assoc. 1996 Dec;67(12):749-54.

    PMID: 9286316BACKGROUND

  • Fulk GW; Cyert LA; Parker DE; A 3-year clinical trial of bifocals to slow myopia progression in children with near-point esophoria: Baseline characteristics., Invest Ophthalmol Vis Sci 1997;38(4):S1158

    BACKGROUND

  • Fulk GW, Cyert LA, Parker DE. A randomized trial of the effect of single-vision vs. bifocal lenses on myopia progression in children with esophoria. Optom Vis Sci. 2000 Aug;77(8):395-401. doi: 10.1097/00006324-200008000-00006.

    PMID: 10966065BACKGROUND

  • 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

MeSH Terms

Conditions

MyopiaStrabismusEsotropia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye DiseasesOcular Motility DisordersCranial Nerve DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 23, 1999

First Posted

September 24, 1999

Study Start

June 1, 1996

Last Updated

June 24, 2005

Record last verified: 2002-06