Erin C Jenewein, Stephen P Christiansen, Yufeng Zhu, Raymond T Kraker, Adriana P Grigorian, Donny W Suh, Allison I Summers, Silvia Han, Bahram Rahmani, Katie S Connolly, Patricia L Davis, Jennifer H Fisher, Yasmin F Javed, Courtney L Kraus, Sudhi P Kurup, Stacy R Martinson, Morgan C Ollinger, Robert G Tauscher, Marilyn Vricella, Wesley T Beaulieu, Stacy L Pineles, Susan A Cotter, Jonathan M Holmes, Katherine K Weise
{"title":"A randomized clinical trial of full-time alternate patching therapy for intermittent exotropia in children.","authors":"Erin C Jenewein, Stephen P Christiansen, Yufeng Zhu, Raymond T Kraker, Adriana P Grigorian, Donny W Suh, Allison I Summers, Silvia Han, Bahram Rahmani, Katie S Connolly, Patricia L Davis, Jennifer H Fisher, Yasmin F Javed, Courtney L Kraus, Sudhi P Kurup, Stacy R Martinson, Morgan C Ollinger, Robert G Tauscher, Marilyn Vricella, Wesley T Beaulieu, Stacy L Pineles, Susan A Cotter, Jonathan M Holmes, Katherine K Weise","doi":"10.1002/ovs2.70015","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>To determine whether 3 months of prescribed full-time alternate patching is more effective than observation for intermittent exotropia (IXT) in children.</p><p><strong>Methods: </strong>We enrolled 73 children aged 3 to <9 years with mean IXT distance control score (3 measures) ≥2 points (on a 0-5 [phoria constant tropia] scale) with at least one score ≥3, 4, or 5 (indicating spontaneous XT over 30-s observation) and a distance exodeviation of 15-50 prism diopters (Δ) by prism and alternate cover test (PACT), with the near deviation not exceeding the distance by > 10Δ. Children were randomly assigned to 3 months full-time patching (all waking hours, 7 days per week, alternating eyes) or observation. The primary outcome was change in mean distance IXT control at 3 months.</p><p><strong>Results: </strong>Baseline mean (SD) distance control for children assigned to full-time patching (N = 36) and observation (N = 37) were 3.6 (0.9) and 3.6 (0.9) points; mean distance PACT was 27Δ (9) and 27Δ (8), respectively. The 3-month visit was completed by 33 (92%) of 36 and 35 (95%) of 37 children assigned to full-time patching and observation. Mean patching adherence was 4.1 h per day (95% CI: 2.8-5.5, N = 20) by participants who returned temperature sensor occlusion dose monitors and 7.4 h per day (95% CI: 5.8-8.9, N = 33) by review of at-home calendars and interviews with parent and child. At 3 months, children in the patching group had greater improvement in mean distance control than the observation group: 0.9 (1.3) versus 0.2 (1.1) points (difference = 0.62 points, 95% CI: 0.04-1.20, p = 0.04). There was also greater improvement in mean distance PACT: 6 (7) versus 2 (7) Δ, difference = 4Δ (95% CI: 1-8, p = 0.02).</p><p><strong>Conclusions: </strong>Three months of prescribed full-time alternate day patching improved distance control and magnitude of IXT in children 3-<9 years, despite mean adherence substantially less than the prescribed full-time regimen. Future studies should evaluate the durability of treatment effects and compare patching to other treatments.</p><p><strong>Trial registration: </strong>Clinicaltrials.Gov, registered 14 July 2022, NCT05462821.</p>","PeriodicalId":520732,"journal":{"name":"Optometry and vision science : official publication of the American Academy of Optometry","volume":"103 2","pages":"e70015"},"PeriodicalIF":1.8000,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Optometry and vision science : official publication of the American Academy of Optometry","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1002/ovs2.70015","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Purpose: To determine whether 3 months of prescribed full-time alternate patching is more effective than observation for intermittent exotropia (IXT) in children.
Methods: We enrolled 73 children aged 3 to <9 years with mean IXT distance control score (3 measures) ≥2 points (on a 0-5 [phoria constant tropia] scale) with at least one score ≥3, 4, or 5 (indicating spontaneous XT over 30-s observation) and a distance exodeviation of 15-50 prism diopters (Δ) by prism and alternate cover test (PACT), with the near deviation not exceeding the distance by > 10Δ. Children were randomly assigned to 3 months full-time patching (all waking hours, 7 days per week, alternating eyes) or observation. The primary outcome was change in mean distance IXT control at 3 months.
Results: Baseline mean (SD) distance control for children assigned to full-time patching (N = 36) and observation (N = 37) were 3.6 (0.9) and 3.6 (0.9) points; mean distance PACT was 27Δ (9) and 27Δ (8), respectively. The 3-month visit was completed by 33 (92%) of 36 and 35 (95%) of 37 children assigned to full-time patching and observation. Mean patching adherence was 4.1 h per day (95% CI: 2.8-5.5, N = 20) by participants who returned temperature sensor occlusion dose monitors and 7.4 h per day (95% CI: 5.8-8.9, N = 33) by review of at-home calendars and interviews with parent and child. At 3 months, children in the patching group had greater improvement in mean distance control than the observation group: 0.9 (1.3) versus 0.2 (1.1) points (difference = 0.62 points, 95% CI: 0.04-1.20, p = 0.04). There was also greater improvement in mean distance PACT: 6 (7) versus 2 (7) Δ, difference = 4Δ (95% CI: 1-8, p = 0.02).
Conclusions: Three months of prescribed full-time alternate day patching improved distance control and magnitude of IXT in children 3-<9 years, despite mean adherence substantially less than the prescribed full-time regimen. Future studies should evaluate the durability of treatment effects and compare patching to other treatments.
Trial registration: Clinicaltrials.Gov, registered 14 July 2022, NCT05462821.
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