A Randomized Trial Comparing Part-time Patching with Observation for Intermittent Exotropia in Children 12 to 35 Months of Age

作者：Mohney Brian G^*; Cotter Susan A; Chandler Danielle L; Holmes Jonathan M; Chen Angela M; Melia Michele; Donahue Sean P; Wallace David K; Kraker Raymond T; Christian Melanie L; Suh Donny W

来源：Ophthalmology, 2015, 122(8): 1718-1725.

DOI：10.1016/j.ophtha.2015.04.025

Purpose: To determine the effectiveness of part-time patching for treating intermittent exotropia (IXT) in young children.
Design: Multicenter, randomized clinical trial.
Participants: Two hundred one children 12 to 35 months of age with untreated IXT meeting the following criteria: (1) IXT at distance OR constant exotropia at distance and either IXT or exophoria at near, and (2) 15-prism diopter (Delta) or more exodeviation at distance or near by prism and alternate cover test (PACT) but at least 10 Delta exodeviation at distance by PACT.
Methods: Participants were assigned randomly to either observation (no treatment for 6 months) or patching prescribed for 3 hours daily for 5 months, followed by 1 month of no patching.
Main Outcome Measures: The primary outcome was deterioration, defined as constant exotropia measuring at least 10 Delta at distance and near or receipt of nonprotocol treatment for IXT.
Results: Of the 177 participants (88%) completing the 6-month primary outcome examination, deterioration occurred in 4.6% (4 of 87) of the participants in the observation group and in 2.2% (2 of 90) of the participants in the patching group (difference, 2.4%; P = 0.27; 95% confidence interval, -3.8% to +9.4%). Motor deterioration occurred in 2.3% (2 of 87) of the observation group and in 2.2% (2 of 90) of the patching group (difference, 0.08%; P = 0.55; 95% confidence interval, -5.8% to +6.1%). For the observation and patching groups, respectively, 6-month mean PACT measurements were 27.9 Delta versus 24.9 Delta at distance (P = 0.02) and 19.3 Delta versus 17.0 Delta at near (P = 0.10); 6-month mean exotropia control scores were 2.8 versus 2.3 points at distance (P = 0.02) and 1.4 versus 1.1 points at near (P = 0.26).
Conclusions: Among children 12 to 35 months of age with previously untreated IXT, deterioration over 6 months was uncommon, with or without patching treatment. There was insufficient evidence to recommend part-time patching for the treatment of IXT in children in this age group.

• 出版日期2015-8