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.

Figure 1.

Patient flow though randomized clinical trial of immediate versus delayed glasses for moderate hyperopia in children 3 to 5 years of age. One participant in the glasses group and one in the observation (delayed glasses) group completed the 36-month visit but did not complete the required additional follow-up visit to reassess failure after receiving a new glasses prescription. These participants are not reported as dropped in the figure.

Figure 2.

Estimates of Deterioration Rate in Observation (delayed glasses) Group during a randomized clinical trial of immediate versus delayed glasses for moderate hyperopia in children 3 to 5 years of age

Figure 3A.

Change in Refractive Error from Baseline to 3 Years for Eye with Greater Hyperopia at Baseline in a randomized clinical trial of immediate versus delayed glasses for moderate hyperopia in children 3 to 5 years of age. The top and bottom of each box represents the 75^th and 25^th percentiles of the data, respectively. Group medians are represented by the bold horizontal lines in each box and group means by the filled circles. The bars extending above and below each box represent 1.5 times the interquartile range (difference between the 75^th and 25^th percentiles), or the maximum (or minimum) observed value within the range if not as extreme as the calculated value. Open circles represent reported refractive errors.

Figure 3B.

Change in Refractive Error from Baseline to 3 Years for Eye with Less Hyperopia at Baseline in a randomized clinical trial of immediate versus delayed glasses for moderate hyperopia in children 3 to 5 years of age. The top and bottom of each box represents the 75^th and 25^th percentiles of the data, respectively. Group medians are represented by the bold horizontal lines in each box and group means by the filled circles. The bars extending above and below each box represent 1.5 times the interquartile range (difference between the 75^th and 25^th percentiles), or the maximum (or minimum) observed value within the range if not as extreme as the calculated value. Open circles represent reported refractive errors.