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AMERICAN JOURNAL OF OPHTHALMOLOGY

VOLUME 208

DECEMBER 2019, PAGES 145-159



A RANDOMIZED CLINICAL TRIAL OF IMMEDIATE VERSUS DELAYED GLASSES FOR MODERATE HYPEROPIA IN CHILDREN 3 TO 5 YEARS OF AGE

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.

AMerican Journal of Ophthalmology.jpg

A RANDOMIZED CLINICAL TRIAL OF IMMEDIATE VERSUS DELAYED GLASSES FOR MODERATE HYPEROPIA IN CHILDREN 3 TO 5 YEARS OF AGE

􀀁 PURPOSE: To compare visual acuity (VA) and binocu-larity 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 chil-dren with hyperopia between D3.00D and D6.00D spherical equivalent were randomly assigned to glasses versus observation (with glasses prescribed if deteriorated for subnormal distance VA or near stereoacuity, or man-ifest 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; man-ifest 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 obser-vation for moderately hyperopic 3- to 5-year-old children with normal VA and binocularity, failure for VA or binocularity was not common. With insufficient enroll-ment 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 pre-vent failure for VA and/or binocularity. (Am J Ophthalmol 2019;208:145–159. 2019 Elsevier Inc. All rights reserved.)

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