Objective
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-old with untreated IXT meeting the following criteria: 1) IXT at distance OR constant exotropia at distance and either IXT or exophoria at near; 2) ≥15 prism diopter (Δ) exodeviation at distance or near by prism and alternate cover test (PACT) but at least 10Δ exodeviation at distance by PACT.
Methods
Participants were randomly assigned 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 Measure
The primary outcome was deterioration, defined as constant exotropia measuring at least 10Δ at distance and near or receipt of non-protocol 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 (CI) = -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% CI = -5.8% to +6.1%). For the observation and patching groups respectively, 6-month mean PACT measurements were 27.9Δ versus 24.9Δ at distance (P = 0.02) and 19.3Δ versus 17.0Δ at near (P = 0.10); 6-month mean exotropia control scores were 2.8 vs. 2.3 points at distance (P = 0.02), and 1.4 vs. 1.1 points at near (P = 0.26).
Conclusion
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.