A randomized trial comparing part-time patching with observation for children 3 to 10 years of age with intermittent exotropia

Abstract

Objective: To determine the effectiveness of prescribed part-time patching for treatment of intermittent exotropia (IXT) in children.

Design: Multicenter, randomized clinical trial.

Participants: 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.

Methods: 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.

Main outcome measures: 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.

Results: 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).

Conclusions: 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.

Figure 1. Flow of Participants through Study

^aFor the 3-month visit, 3 participants in the observation group and 2 participants in the patching group had the visit but did not complete some or all of the masked exam portion. For the 6-month visit, 2 participants in each treatment group had the visit but did not complete some or all of the masked exam portion. ^bIncludes 4 observation group participants and 2 patching group participants who are continuing in longer-term study follow-up but did not complete the 6-month visit and therefore are excluded from the primary analysis. ^cNumber of participants completing the initial masked exam testing at the 6-month visit (i.e. criteria for inclusion in the 6-month analysis), regardless of whether they met deterioration criteria at 3 months. Of these participants, those who met deterioration criteria at the 3-month visit were considered to be deteriorated by 6 months.