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

Marjean T. Kulp, Jonathan M. Holmes, Trevano W. Dean, Donny W. Suh, Donny W Suh, David K. Wallace, David B. Petersen, Susan A. Cotter, Ruth E. Manny, Rosanne Superstein, Tawna L. Roberts, John M. Avallone, Deborah R. Fishman, S. Ayse Erzurum, David A. Leske, Alex Christoff

Research output: Contribution to journalArticle

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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).

Original languageEnglish (US)
Pages (from-to)876-887
Number of pages12
JournalOphthalmology
Volume126
Issue number6
DOIs
StatePublished - Jun 1 2019

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Hyperopia
Glass
Randomized Controlled Trials
Strabismus
Observation
Visual Acuity
Mydriatics
Confidence Intervals
Prescriptions
Anisometropia
Astigmatism
Outcome Assessment (Health Care)

ASJC Scopus subject areas

  • Ophthalmology

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A Randomized Clinical Trial of Immediate versus Delayed Glasses for Moderate Hyperopia in 1- and 2-Year-Olds. / Kulp, Marjean T.; Holmes, Jonathan M.; Dean, Trevano W.; Suh, Donny W.; Suh, Donny W; Wallace, David K.; Petersen, David B.; Cotter, Susan A.; Manny, Ruth E.; Superstein, Rosanne; Roberts, Tawna L.; Avallone, John M.; Fishman, Deborah R.; Erzurum, S. Ayse; Leske, David A.; Christoff, Alex.

In: Ophthalmology, Vol. 126, No. 6, 01.06.2019, p. 876-887.

Research output: Contribution to journalArticle

Kulp, MT, Holmes, JM, Dean, TW, Suh, DW, Suh, DW, Wallace, DK, Petersen, DB, Cotter, SA, Manny, RE, Superstein, R, Roberts, TL, Avallone, JM, Fishman, DR, Erzurum, SA, Leske, DA & Christoff, A 2019, 'A Randomized Clinical Trial of Immediate versus Delayed Glasses for Moderate Hyperopia in 1- and 2-Year-Olds', Ophthalmology, vol. 126, no. 6, pp. 876-887. https://doi.org/10.1016/j.ophtha.2018.12.049
Kulp, Marjean T. ; Holmes, Jonathan M. ; Dean, Trevano W. ; Suh, Donny W. ; Suh, Donny W ; Wallace, David K. ; Petersen, David B. ; Cotter, Susan A. ; Manny, Ruth E. ; Superstein, Rosanne ; Roberts, Tawna L. ; Avallone, John M. ; Fishman, Deborah R. ; Erzurum, S. Ayse ; Leske, David A. ; Christoff, Alex. / A Randomized Clinical Trial of Immediate versus Delayed Glasses for Moderate Hyperopia in 1- and 2-Year-Olds. In: Ophthalmology. 2019 ; Vol. 126, No. 6. pp. 876-887.
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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).",
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T1 - A Randomized Clinical Trial of Immediate versus Delayed Glasses for Moderate Hyperopia in 1- and 2-Year-Olds

AU - Kulp, Marjean T.

AU - Holmes, Jonathan M.

AU - Dean, Trevano W.

AU - Suh, Donny W.

AU - Suh, Donny W

AU - Wallace, David K.

AU - Petersen, David B.

AU - Cotter, Susan A.

AU - Manny, Ruth E.

AU - Superstein, Rosanne

AU - Roberts, Tawna L.

AU - Avallone, John M.

AU - Fishman, Deborah R.

AU - Erzurum, S. Ayse

AU - Leske, David A.

AU - Christoff, Alex

PY - 2019/6/1

Y1 - 2019/6/1

N2 - 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).

AB - 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).

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