Cotter Susan A, Mohney Brian G, Chandler Danielle L, Holmes Jonathan M, Repka Michael X, Melia Michele, Wallace David K, Beck Roy W, Birch Eileen E, Kraker Raymond T, Tamkins Susanna M, Miller Aaron M, Sala Nicholas A, Glaser Stephen R
Southern California College of Optometry, Marshall B. Ketchum University, Fullerton, California.
Mayo Clinic, Rochester, Minnesota.
Ophthalmology. 2014 Dec;121(12):2299-310. doi: 10.1016/j.ophtha.2014.07.021. Epub 2014 Sep 16.
To determine the effectiveness of prescribed part-time patching for treatment of intermittent exotropia (IXT) in children.
Multicenter, randomized clinical trial.
Three hundred fifty-eight children 3 to <11 years of age with previously untreated (except for refractive correction) IXT and near stereoacuity of 400 seconds of arc or better were enrolled. Intermittent exotropia met the following criteria: (1) IXT at distance OR constant exotropia at distance and either IXT or exophoria at near; (2) exodeviation (tropia or phoria) of at least 15 prism diopters (PD) at distance or near by prism and alternate cover test (PACT); and (3) exodeviation of at least 10 PD at distance by PACT.
Participants were assigned randomly either to observation (no treatment for 6 months) or to patching for 3 hours daily for 5 months, with a 1-month washout period of no patching before the 6-month primary outcome examination.
The primary outcome was deterioration at either the 3-month or the 6-month follow-up visit, defined as: (1) constant exotropia measuring at least 10 PD at distance and near by simultaneous prism and cover test, and/or (2) near stereoacuity decreased by at least 2 octaves from baseline, both assessed by a masked examiner and confirmed by a retest. Participants who were prescribed any nonrandomized treatment without first meeting either deterioration criteria also were counted as having deteriorated.
Of the 324 participants (91%) completing the 6-month primary outcome examination, deterioration occurred in 10 of the 165 participants (6.1%) in the observation group (3 of these 10 started treatment without meeting deterioration criteria) and in 1 of the 159 participants (0.6%) in the part-time patching group (difference, 5.4%; lower limit of 1-sided exact 95% confidence interval, 2.0%; P = 0.004, 1-sided hypothesis test).
Deterioration of previously untreated childhood IXT over a 6-month period is uncommon with or without patching treatment. Although there is a slightly lower deterioration rate with patching, both management approaches are reasonable for treating children 3 to 10 years of age with IXT.
确定规定的部分时间遮盖疗法治疗儿童间歇性外斜视（IXT）的有效性。
多中心随机临床试验。
招募了358名3至11岁、此前未接受过治疗（除屈光矫正外）的IXT儿童，其近立体视锐度为400角秒或更好。间歇性外斜视符合以下标准：（1）远距离间歇性外斜视或远距离恒定性外斜视，且近距离为间歇性外斜视或外隐斜；（2）通过棱镜交替遮盖试验（PACT），远距离或近距离的外斜度（斜视或隐斜）至少为15棱镜度（PD）；（3）通过PACT，远距离外斜度至少为10 PD。
参与者被随机分配至观察组（6个月不治疗）或每天遮盖3小时、持续5个月的遮盖组，在6个月主要结局检查前有1个月不遮盖的洗脱期。
主要结局为3个月或6个月随访时病情恶化，定义为：（1）通过同时棱镜遮盖试验，远距离和近距离的恒定性外斜视至少为10 PD，和/或（2）近立体视锐度较基线下降至少2个倍频程，均由一名盲法检查者评估并经复测确认。在未首先满足任一病情恶化标准的情况下接受任何非随机治疗的参与者也被计为病情恶化。
在完成6个月主要结局检查的324名参与者（91%）中，观察组165名参与者中有10名（6.1%）病情恶化（这10名中有3名在未满足病情恶化标准时开始治疗），部分时间遮盖组159名参与者中有1名（0.6%）病情恶化（差异为5.4%；单侧精确95%置信区间下限为2.0%；P = 0.004，单侧假设检验）。
无论是否进行遮盖治疗，未经治疗的儿童IXT在6个月内病情恶化均不常见。虽然遮盖疗法的病情恶化率略低，但两种治疗方法对于治疗3至10岁的IXT儿童都是合理的。
