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Randomized Controlled Trial
. 2024 May 1;142(5):417-428.
doi: 10.1001/jamaophthalmol.2024.0276.

Refractive Error Change and Overminus Lens Therapy for Childhood Intermittent Exotropia

Writing Committee for the Pediatric Eye Disease Investigator Group; Pediatric Eye Disease Investigator Group; Angela M Chen  1 , S Ayse Erzurum  2 , Danielle L Chandler  3 , Amra Hercinovic  3 , Rui Wu  3 , Marilyn Vricella  4 , Amy L Waters  5 , Benjamin H Ticho  6 , John W Erickson  7 , Silvia Han  1 , Paula S McDowell  8 , Zhuokai Li  3 , Raymond T Kraker  3 , Jonathan M Holmes  9 , Susan A Cotter  1
Collaborators, Affiliations
Randomized Controlled Trial

Refractive Error Change and Overminus Lens Therapy for Childhood Intermittent Exotropia

Writing Committee for the Pediatric Eye Disease Investigator Group et al. JAMA Ophthalmol. .

Abstract

Importance: Increased myopic shift was found to be associated with 1 year of overminus spectacle treatment for children with intermittent exotropia (IXT). Persistence of myopic shift after discontinuing overminus spectacles is unknown.

Objective: To compare refractive error change over 3 years in children with IXT originally treated with overminus vs nonoverminus spectacles.

Design, setting, and participants: This study was an 18-month extension of the Trial of Overminus Spectacle Therapy for Intermittent Exotropia cohort, which previously randomized children aged 3 to 10 years with IXT and baseline spherical equivalent refractive error (SER) between -6.00 diopters (D) and 1.00 D to overminus spectacles (-2.50 D for 12 months, -1.25 D for 3 months, and nonoverminus for 3 months) or nonoverminus spectacles. Children were recruited from 56 sites from July 2010 to February 2022. Data were analyzed from February 2022 to January 2024.

Interventions: After trial completion at 18 months, participants were followed up at 24 and 36 months. Treatment was at investigator discretion from 18 to 36 months.

Main outcomes and measures: Change in SER (cycloplegic retinoscopy) from baseline to 36 months.

Results: Of 386 children in the Trial of Overminus Spectacle Therapy for Intermittent Exotropia, 223 (57.8%) consented to 18 months of additional follow-up, including 124 of 196 (63.3%) in the overminus treatment group and 99 of 190 (52.1%) in the nonoverminus treatment group. Of 205 children who completed 36-month follow-up, 116 (56.6%) were female, and the mean (SD) age at randomization was 6.2 (2.1) years. Mean (SD) SER change from baseline to 36 months was greater in the overminus group (-0.74 [1.00] D) compared with the nonoverminus group (-0.44 [0.85] D; adjusted difference, -0.36 D; 95% CI, -0.59 to -0.12; P = .003), with 30 of 112 (26.8%) in the overminus group having more than 1 D of myopic shift compared with 14 of 91 (15%) in the nonoverminus group (risk ratio, 1.8; 95% CI, 1.0-3.0). From 12 to 36 months, mean (SD) myopic shift was -0.34 (0.67) D and -0.36 (0.66) D in the overminus and nonoverminus groups, respectively (adjusted difference, -0.001 D; 95% CI, -0.18 to 0.18; P = .99).

Conclusions and relevance: The greater myopic shift observed after 1 year of -2.50-D overminus lens treatment remained at 3 years. Both groups had similar myopic shift during the 2-year period after treatment weaning and cessation. The risk of myopic shift should be discussed with parents when considering overminus lens treatment.

Trial registration: ClinicalTrials.gov Identifier: NCT02807350.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Chandler reported grants from the National Eye Institute during the conduct of the study. Dr Wu reported grants from Jaeb Center for Health Research during the conduct of the study. Dr Vricella reported grants from the National Eye Institute paid to the Jaeb Center for Health Research during the conduct of the study as well as grants from the National Eye Institute outside the submitted work. Dr Waters reported grants and personal fees from the Pediatric Eye Disease Investigator Group during the conduct of the study as well as grants, personal fees, and nonfinancial support from the Pediatric Eye Disease Investigator Group outside the submitted work. Dr McDowell reported reimbursement from the Pediatric Eye Disease Investigator Group and National Institutes of Health during the conduct of the study. Dr Li reported grants from the National Eye Institute during the conduct of the study. Dr Kraker reported grants from the National Eye Institute during the conduct of the study. Dr Holmes reported grants from the National Institutes of Health during the conduct of the study as well as grants from the National Institutes of Health outside the submitted work. Dr Cotter reported grants from the National Eye Institute during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Study Flowchart
aSeven in the overminus group and 4 in the nonoverminus group completed the 24-month visit out of the analysis window (≥630 and ≤899 days from randomization) for the primary analysis. bOne in the overminus group and 3 in the nonoverminus group completed the 30-month visit out of the analysis window (≥900 and ≤1440 days from randomization) for the primary analysis.
Figure 2.
Figure 2.. Mean Change in Spherical Equivalent Refractive Error (SER) by Treatment Group Over 36 Months
The change from baseline in SER (diopters [D]) are shown at each visit by treatment group. Participants in the overminus group received full treatment (spectacles of −2.50 D) from months 0 to 12, half treatment (spectacles of −1.25 D) from months 12 to 15, and no treatment from months 15 to 18. Treatment was at investigator discretion from months 18 to 36 for participants in both the overminus and nonoverminus groups. The number of participants at 18 months was smaller because the cycloplegic refraction was implemented for the remaining 18-month visits after the discontinuation of overminus lenses, which was 2 years and 10 months after the randomized clinical trial commenced (10 months after enrollment ended) after the data and safety monitoring committee observed greater myopic shift over 12 months in the overminus group. Error bars indicate 95% CIs.
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