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Randomized Controlled Trial
. 2015 Aug;122(8):1718-25.
doi: 10.1016/j.ophtha.2015.04.025. Epub 2015 Jun 11.

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

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Randomized Controlled Trial

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

Pediatric Eye Disease Investigator Group et al. Ophthalmology. .
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Abstract

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 (Δ) or more exodeviation at distance or near by prism and alternate cover test (PACT) but at least 10 Δ 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 Δ 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 Δ versus 24.9 Δ at distance (P = 0.02) and 19.3 Δ versus 17.0 Δ 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.

Conflict of interest statement

Conflict of Interest: No conflicting relationships exist for any author.

Figures

Figure 1
Figure 1. Flow of Participants through Study
aDue to poor cooperation, masked alignment testing could not be completed for 5 participants at the 3-month visit (3 in observation and 2 in patching) and 2 participants at the 6-month visit (1 in each group). bThe observation group includes 1 participant who was lost to follow-up and 2 participants who are continuing in the longer-term study follow-up but did not complete the 6-month visit and therefore are excluded from the analysis. The patching group includes 4 participants who were lost to follow-up and 3 participants who are continuing in the longer-term study follow-up but did not complete the 6-month visit and therefore are excluded from the analysis. cIn the observation group, 2 participants were withdrawn from the study for outcome-related reasons. One child's mother and the pediatrician felt the IXT had resolved. The other child's parents felt their child's eyes were getting worse and wanted surgery. dIn the patching group, parents withdrew 1 child because they were transferring care to another ophthalmologist.

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