Optometry and vision science : official publication of the American Academy of Optometry · 2026
A randomized clinical trial of full-time alternate patching therapy for intermittent exotropia in children.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Jenewein Erin C, Christiansen Stephen P, Zhu Yufeng, Kraker Raymond T, Grigorian Adriana P, Suh Donny W, Summers Allison I, Han Silvia, Rahmani Bahram, Connolly Katie S, Davis Patricia L, Fisher Jennifer H, Javed Yasmin F, Kraus Courtney L, Kurup Sudhi P, Martinson Stacy R, Ollinger Morgan C, Tauscher Robert G, Vricella Marilyn, Beaulieu Wesley T, Pineles Stacy L, Cotter Susan A, Holmes Jonathan M, Weise Katherine K, Pediatric Eye Disease Investigator Group
Аннотация
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.
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.