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Original Investigation
March 4, 2021

Overminus Lens Therapy for Children 3 to 10 Years of Age With Intermittent Exotropia: A Randomized Clinical Trial

Author Affiliations
  • 1Southern California College of Optometry at Marshall B. Ketchum University, Fullerton
  • 2Eye Care Associates, Inc, Poland, Ohio
  • 3Jaeb Center for Health Research, Tampa, Florida
  • 4Texas Children's Hospital, Houston
  • 5University of Nebraska Medical Center, Omaha
  • 6State University of New York, College of Optometry, New York
  • 7Nemours Children's Clinic, Jacksonville, Florida
  • 8Houston Eye Associates, The Woodlands, Texas
  • 9Children's Mercy Hospitals and Clinics, Kansas City, Missouri
  • 10Southern College of Optometry, Memphis, Tennessee
  • 11Virginia Pediatric Eye Center, Virginia Beach
  • 12Boston Medical Center, Boston, Massachusetts
  • 13Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio
  • 14Arkansas Children’s Hospital, University of Arkansas Medical Sciences, Little Rock
  • 15Baylor College of Medicine, Houston, Texas
  • 16Ann and Robert H. Lurie Children’s Hospital of Chicago, Chicago, Illinois
  • 17The Eye Specialist Center, LLC, Munster, Indiana
  • 18University of Arizona, Tucson
JAMA Ophthalmol. 2021;139(4):464-476. doi:10.1001/jamaophthalmol.2021.0082
Key Points

Question  Does overminus lens therapy improve distance control in children with intermittent exotropia?

Findings  This randomized clinical trial found that mean distance exotropia control was significantly better among 386 children aged 3 to 10 years treated with overminus spectacles vs nonoverminus spectacles for 12 months; however, after weaning off overminus spectacles, there was little or no difference in distance control between groups. Myopic shift was approximately one-third diopter greater in the overminus than in the nonoverminus group.

Meaning  Overminus lens therapy improved distance exotropia control in children 3 to 10 years of age but was associated with greater myopic shift, and the improved control did not persist after overminus treatment was discontinued.

Abstract

Importance  This is the first large-scale randomized clinical trial evaluating the effectiveness and safety of overminus spectacle therapy for treatment of intermittent exotropia (IXT).

Objective  To evaluate the effectiveness of overminus spectacles to improve distance IXT control.

Design, Setting, and Participants  This randomized clinical trial conducted at 56 clinical sites between January 2017 and January 2019 associated with the Pediatric Eye Disease Investigator Group enrolled 386 children aged 3 to 10 years with IXT, a mean distance control score of 2 or worse, and a refractive error between 1.00 and −6.00 diopters (D). Data analysis was performed from February to December 2020.

Interventions  Participants were randomly assigned to overminus spectacle therapy (−2.50 D for 12 months, then −1.25 D for 3 months, followed by nonoverminus spectacles for 3 months) or to nonoverminus spectacle use.

Main Outcomes and Measures  Primary and secondary outcomes were the mean distance IXT control scores of participants examined after 12 months of treatment (primary outcome) and at 18 months (3 months after treatment ended) assessed by an examiner masked to treatment group. Change in refractive error from baseline to 12 months was compared between groups. Analyses were performed using the intention-to-treat population.

Results  The mean (SD) age of 196 participants randomized to overminus therapy and 190 participants randomized to nonoverminus treatment was 6.3 (2.1) years, and 226 (59%) were female. Mean distance control at 12 months was better in participants treated with overminus spectacles than with nonoverminus spectacles (1.8 vs 2.8 points; adjusted difference, −0.8; 95% CI, −1.0 to −0.5; P < .001). At 18 months, there was little or no difference in mean distance control between overminus and nonoverminus groups (2.4 vs 2.7 points; adjusted difference, −0.2; 95% CI, −0.5 to 0.04; P = .09). Myopic shift from baseline to 12 months was greater in the overminus than the nonoverminus group (−0.42 D vs −0.04 D; adjusted difference, −0.37 D; 95% CI, −0.49 to −0.26 D; P < .001), with 33 of 189 children (17%) in the overminus group vs 2 of 169 (1%) in the nonoverminus group having a shift higher than 1.00 D.

Conclusions and Relevance  Children 3 to 10 years of age had improved distance exotropia control when assessed wearing overminus spectacles after 12 months of overminus treatment; however, this treatment was associated with increased myopic shift. The beneficial effect of overminus lens therapy on distance exotropia control was not maintained after treatment was tapered off for 3 months and children were examined 3 months later.

Trial Registration  ClinicalTrials.gov Identifier: NCT02807350

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