A Randomized Clinical Trial of Immediate versus Delayed Glasses for Moderate Hyperopia in 1- and 2-Year-Olds.


Journal

Ophthalmology
ISSN: 1549-4713
Titre abrégé: Ophthalmology
Pays: United States
ID NLM: 7802443

Informations de publication

Date de publication:
06 2019
Historique:
received: 16 08 2018
revised: 05 12 2018
accepted: 27 12 2018
pubmed: 8 1 2019
medline: 25 1 2020
entrez: 8 1 2019
Statut: ppublish

Résumé

Two strategies were compared for managing moderate hyperopia without manifest strabismus among 1- and 2-year-old children: (1) immediate prescription of glasses versus (2) observation without glasses unless reduced distance visual acuity (VA), reduced stereoacuity, or manifest strabismus. Prospective randomized clinical trial. A total of 130 children aged 1 to 2 years with hyperopia between +3.00 diopters (D) and +6.00 D spherical equivalent (SE) in at least 1 eye, anisometropia ≤1.50 D SE, and astigmatism ≤1.50 D based on cycloplegic refraction and no manifest strabismus. Participants were randomly assigned to glasses (1.00 D less than full cycloplegic hyperopia) versus observation and followed every 6 months for 3 years. Glasses were prescribed to those assigned to observation if they met prespecified deterioration criteria of distance VA or near stereoacuity below age norms, or development of manifest strabismus. At the 3-year primary outcome examination, participants were classified as failing the randomized management regimen if distance VA or stereoacuity was below age norms or manifest strabismus was observed (each with and without correction in trial frames, confirmed by masked retest, irrespective of whether deterioration had occurred previously), or if strabismus surgery had been performed. Of the 106 participants (82%) completing the 3-year primary outcome examination, failure occurred in 11 (21%) of 53 in the glasses group and 18 (34%) of 53 in the observation group (difference = -13%; 95% confidence interval [CI], -31 to 4; P = 0.14). Sixty-two percent (95% CI, 49-74) in the observation group and 34% (95% CI, 23-48) in the glasses group met deterioration criteria (requiring glasses if not wearing). For 1- and 2-year-olds with uncorrected moderate hyperopia (+3.00 D to +6.00 D SE), our estimates of failure, after 3 years of 6-month follow-ups, are inconclusive and consistent with a small to moderate benefit or no benefit of immediate prescription of glasses compared with careful observation (with glasses only if deteriorated).

Identifiants

pubmed: 30615896
pii: S0161-6420(18)32101-8
doi: 10.1016/j.ophtha.2018.12.049
pmc: PMC6534446
mid: NIHMS1521511
pii:
doi:

Types de publication

Comparative Study Journal Article Randomized Controlled Trial Research Support, N.I.H., Extramural

Langues

eng

Sous-ensembles de citation

IM

Pagination

876-887

Subventions

Organisme : NEI NIH HHS
ID : U10 EY011751
Pays : United States
Organisme : NEI NIH HHS
ID : U10 EY018810
Pays : United States
Organisme : NEI NIH HHS
ID : U10 EY023198
Pays : United States
Organisme : NEI NIH HHS
ID : UG1 EY011751
Pays : United States

Informations de copyright

Copyright © 2019 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

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Auteurs

Marjean T Kulp (MT)

College of Optometry, The Ohio State University, Columbus, Ohio. Electronic address: pedig@jaeb.org.

Jonathan M Holmes (JM)

Mayo Clinic, Rochester, Minnesota.

Trevano W Dean (TW)

Jaeb Center for Health Research, Tampa, Florida.

Donny W Suh (DW)

University of Nebraska Medical Center, Omaha, Nebraska.

Raymond T Kraker (RT)

Jaeb Center for Health Research, Tampa, Florida.

David K Wallace (DK)

Indiana University, Indianapolis, Indiana.

David B Petersen (DB)

Rocky Mountain Eye Care Associates, Salt Lake City, Utah.

Susan A Cotter (SA)

Southern California College of Optometry at Marshall B. Ketchum University, Fullerton, California.

Ruth E Manny (RE)

University of Houston College of Optometry, Houston, Texas.

Rosanne Superstein (R)

Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada.

Tawna L Roberts (TL)

Byers Eye Institute, Stanford University, Palo Alto, CA.

John M Avallone (JM)

Ophthalmology Associates of Greater Annapolis, Arnold, Maryland.

Deborah R Fishman (DR)

Pediatric Eye Associates, Wilmette, Illinois.

S Ayse Erzurum (SA)

Eye Care Associates, Inc., Poland, Ohio.

David A Leske (DA)

Mayo Clinic, Rochester, Minnesota.

Alex Christoff (A)

Wilmer Eye Institute, Baltimore, Maryland.

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