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


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.

SUBMITTER: Pediatric Eye Disease Investigator Group 

PROVIDER: S-EPMC4516562 | biostudies-literature | 2015 Aug

REPOSITORIES: biostudies-literature

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Publications

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

Mohney Brian G BG   Cotter Susan A SA   Chandler Danielle L DL   Holmes Jonathan M JM   Chen Angela M AM   Melia Michele M   Donahue Sean P SP   Wallace David K DK   Kraker Raymond T RT   Christian Melanie L ML   Suh Donny W DW  

Ophthalmology 20150611 8


<h4>Purpose</h4>To determine the effectiveness of part-time patching for treating intermittent exotropia (IXT) in young children.<h4>Design</h4>Multicenter, randomized clinical trial.<h4>Participants</h4>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 (P  ...[more]

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