Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2019 Jun;126(6):876-887.
doi: 10.1016/j.ophtha.2018.12.049. Epub 2019 Jan 4.

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

Pediatric Eye Disease Investigator Group; Marjean T Kulp  1 , Jonathan M Holmes  2 , Trevano W Dean  3 , Donny W Suh  4 , Raymond T Kraker  3 , David K Wallace  5 , David B Petersen  6 , Susan A Cotter  7 , Ruth E Manny  8 , Rosanne Superstein  9 , Tawna L Roberts  10 , John M Avallone  11 , Deborah R Fishman  12 , S Ayse Erzurum  13 , David A Leske  2 , Alex Christoff  14
Affiliations
Randomized Controlled Trial

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

Pediatric Eye Disease Investigator Group et al. Ophthalmology. 2019 Jun.

Abstract

Purpose: 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.

Design: Prospective randomized clinical trial.

Participants: 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.

Methods: 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.

Main outcome measures: 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.

Results: 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).

Conclusions: 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).

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest: No conflicting relationships exist for any author.

Figures

Figure 1.
Figure 1.. Visit Completion by Treatment Group.
Diagram showing flow of participants through the study. One participant in the glasses group and one in the observation group completed the 36-month visit but did not complete the required follow-up visit after receiving a new glasses prescription.
Figure 2.
Figure 2.. Kaplan-Meier Estimates of Deterioration in Observation Group
See this image and copyright information in PMC

References

    1. Ip JM, Robaei D, Kifley A, et al. Prevalence of hyperopia and associations with eye findings in 6- and 12-year-olds. Ophthalmology 2008;115(4):678–85 e1. - PubMed
    1. Atkinson J, Braddick O, Bobier B, et al. Two infant vision screening programmes: prediction and prevention of strabismus and amblyopia from photo- and videorefractive screening. Eye (Lond) 1996;10 ( Pt 2):189–98. - PubMed
    1. Ingram RM, Walker C, Wilson JM, et al. Prediction of amblyopia and squint by means of refraction at age 1 year. Br J Ophthalmol 1986;70(1):12–5. - PMC - PubMed
    1. Klimek DL, Cruz OA, Scott WE, Davitt BV. Isoametropic amblyopia due to high hyperopia in children. J AAPOS 2004;8(4):310–3. - PubMed
    1. Ingram RM. Refraction as a basis for screening children for squint and amblyopia. Br J Ophthalmol 1977;61(1):8–15. - PMC - PubMed

Publication types