A Randomized Clinical Trial of Immediate Versus Delayed Glasses for Moderate Hyperopia in Children 3 to 5 Years of Age

Pediatric Eye Disease Investigator Group

Research output: Contribution to journalArticle

Abstract

Purpose: To compare visual acuity (VA) and binocularity outcomes in moderately hyperopic children with normal VA and binocularity assigned to glasses versus observation. Design: Prospective randomized clinical trial (RCT). Methods: One hundred nineteen 3- to 5-year-old children with hyperopia between +3.00D and +6.00D spherical equivalent were randomly assigned to glasses versus observation (with glasses prescribed if deteriorated for subnormal distance VA or near stereoacuity, or manifest strabismus). Follow-up occurred every 6 months. At 3 years, the treatment strategy was classified as “failed” if any of the following were met, both with and without correction: subnormal distance VA or stereoacuity; manifest strabismus; or strabismus surgery during follow-up. Results: Of 84 (71%) children who completed the primary outcome examination, failure occurred in five (12%; 95% confidence interval [CI]: 4%–26%) of 41 assigned to glasses and four (9%; 95% CI: 3%–22%) of 43 assigned to observation (difference = 3%; 95% CI: -12%–18%; P =.72). Deterioration prior to 3 years (requiring glasses per protocol) occurred in 29% (95% CI: 19%–43%) assigned to glasses and 27% (95% CI: 17%–42%) assigned to observation. Conclusions: In an RCT comparing glasses to observation for moderately hyperopic 3- to 5-year-old children with normal VA and binocularity, failure for VA or binocularity was not common. With insufficient enrollment and retention, our study was unable to determine whether immediate glasses prescription reduces failure rate, but low failure rates suggest that immediate glasses prescription for these children may not be needed to prevent failure for VA and/or binocularity.

Original languageEnglish (US)
Pages (from-to)145-159
Number of pages15
JournalAmerican journal of ophthalmology
Volume208
DOIs
StatePublished - Dec 2019

Fingerprint

Hyperopia
Glass
Randomized Controlled Trials
Visual Acuity
Observation
Confidence Intervals
Strabismus
Prescriptions

ASJC Scopus subject areas

  • Ophthalmology

Cite this

A Randomized Clinical Trial of Immediate Versus Delayed Glasses for Moderate Hyperopia in Children 3 to 5 Years of Age. / Pediatric Eye Disease Investigator Group.

In: American journal of ophthalmology, Vol. 208, 12.2019, p. 145-159.

Research output: Contribution to journalArticle

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title = "A Randomized Clinical Trial of Immediate Versus Delayed Glasses for Moderate Hyperopia in Children 3 to 5 Years of Age",
abstract = "Purpose: To compare visual acuity (VA) and binocularity outcomes in moderately hyperopic children with normal VA and binocularity assigned to glasses versus observation. Design: Prospective randomized clinical trial (RCT). Methods: One hundred nineteen 3- to 5-year-old children with hyperopia between +3.00D and +6.00D spherical equivalent were randomly assigned to glasses versus observation (with glasses prescribed if deteriorated for subnormal distance VA or near stereoacuity, or manifest strabismus). Follow-up occurred every 6 months. At 3 years, the treatment strategy was classified as “failed” if any of the following were met, both with and without correction: subnormal distance VA or stereoacuity; manifest strabismus; or strabismus surgery during follow-up. Results: Of 84 (71{\%}) children who completed the primary outcome examination, failure occurred in five (12{\%}; 95{\%} confidence interval [CI]: 4{\%}–26{\%}) of 41 assigned to glasses and four (9{\%}; 95{\%} CI: 3{\%}–22{\%}) of 43 assigned to observation (difference = 3{\%}; 95{\%} CI: -12{\%}–18{\%}; P =.72). Deterioration prior to 3 years (requiring glasses per protocol) occurred in 29{\%} (95{\%} CI: 19{\%}–43{\%}) assigned to glasses and 27{\%} (95{\%} CI: 17{\%}–42{\%}) assigned to observation. Conclusions: In an RCT comparing glasses to observation for moderately hyperopic 3- to 5-year-old children with normal VA and binocularity, failure for VA or binocularity was not common. With insufficient enrollment and retention, our study was unable to determine whether immediate glasses prescription reduces failure rate, but low failure rates suggest that immediate glasses prescription for these children may not be needed to prevent failure for VA and/or binocularity.",
author = "{Pediatric Eye Disease Investigator Group} and Holmes, {Jonathan M.} and Kulp, {Marjean T.} and Dean, {Trevano W.} and Suh, {Donny W.} and Kraker, {Raymond T.} and Wallace, {David K.} and Petersen, {David B.} and Cotter, {Susan A.} and Crouch, {Earl R.} and Lorenzana, {Ingryd J.} and Ticho, {Benjamin H.} and Verderber, {Lisa C.} and Weise, {Katherine K.}",
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AU - Pediatric Eye Disease Investigator Group

AU - Holmes, Jonathan M.

AU - Kulp, Marjean T.

AU - Dean, Trevano W.

AU - Suh, Donny W.

AU - Kraker, Raymond T.

AU - Wallace, David K.

AU - Petersen, David B.

AU - Cotter, Susan A.

AU - Crouch, Earl R.

AU - Lorenzana, Ingryd J.

AU - Ticho, Benjamin H.

AU - Verderber, Lisa C.

AU - Weise, Katherine K.

PY - 2019/12

Y1 - 2019/12

N2 - Purpose: To compare visual acuity (VA) and binocularity outcomes in moderately hyperopic children with normal VA and binocularity assigned to glasses versus observation. Design: Prospective randomized clinical trial (RCT). Methods: One hundred nineteen 3- to 5-year-old children with hyperopia between +3.00D and +6.00D spherical equivalent were randomly assigned to glasses versus observation (with glasses prescribed if deteriorated for subnormal distance VA or near stereoacuity, or manifest strabismus). Follow-up occurred every 6 months. At 3 years, the treatment strategy was classified as “failed” if any of the following were met, both with and without correction: subnormal distance VA or stereoacuity; manifest strabismus; or strabismus surgery during follow-up. Results: Of 84 (71%) children who completed the primary outcome examination, failure occurred in five (12%; 95% confidence interval [CI]: 4%–26%) of 41 assigned to glasses and four (9%; 95% CI: 3%–22%) of 43 assigned to observation (difference = 3%; 95% CI: -12%–18%; P =.72). Deterioration prior to 3 years (requiring glasses per protocol) occurred in 29% (95% CI: 19%–43%) assigned to glasses and 27% (95% CI: 17%–42%) assigned to observation. Conclusions: In an RCT comparing glasses to observation for moderately hyperopic 3- to 5-year-old children with normal VA and binocularity, failure for VA or binocularity was not common. With insufficient enrollment and retention, our study was unable to determine whether immediate glasses prescription reduces failure rate, but low failure rates suggest that immediate glasses prescription for these children may not be needed to prevent failure for VA and/or binocularity.

AB - Purpose: To compare visual acuity (VA) and binocularity outcomes in moderately hyperopic children with normal VA and binocularity assigned to glasses versus observation. Design: Prospective randomized clinical trial (RCT). Methods: One hundred nineteen 3- to 5-year-old children with hyperopia between +3.00D and +6.00D spherical equivalent were randomly assigned to glasses versus observation (with glasses prescribed if deteriorated for subnormal distance VA or near stereoacuity, or manifest strabismus). Follow-up occurred every 6 months. At 3 years, the treatment strategy was classified as “failed” if any of the following were met, both with and without correction: subnormal distance VA or stereoacuity; manifest strabismus; or strabismus surgery during follow-up. Results: Of 84 (71%) children who completed the primary outcome examination, failure occurred in five (12%; 95% confidence interval [CI]: 4%–26%) of 41 assigned to glasses and four (9%; 95% CI: 3%–22%) of 43 assigned to observation (difference = 3%; 95% CI: -12%–18%; P =.72). Deterioration prior to 3 years (requiring glasses per protocol) occurred in 29% (95% CI: 19%–43%) assigned to glasses and 27% (95% CI: 17%–42%) assigned to observation. Conclusions: In an RCT comparing glasses to observation for moderately hyperopic 3- to 5-year-old children with normal VA and binocularity, failure for VA or binocularity was not common. With insufficient enrollment and retention, our study was unable to determine whether immediate glasses prescription reduces failure rate, but low failure rates suggest that immediate glasses prescription for these children may not be needed to prevent failure for VA and/or binocularity.

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