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A Randomized Trial Comparing Part-time Patching with Observation for Intermittent Exotropia in Children 12 to 35
, Brian G Mohney1, Susan A Cotter2
1Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota.
Insights
Part-time patching did not significantly reduce deterioration in young children with intermittent exotropia (IXT). Deterioration was uncommon in both the patching and observation groups over six months.
Area of Science:
- Ophthalmology
- Pediatric ophthalmology
- Strabismus research
Background:
- Intermittent exotropia (IXT) is a common form of strabismus in children.
- The optimal treatment strategy for IXT in very young children remains under investigation.
- Part-time patching is a potential therapeutic approach for managing IXT.
Purpose of the Study:
- To evaluate the effectiveness of part-time patching in treating intermittent exotropia (IXT) in children aged 12 to 35 months.
- To compare the rate of deterioration in IXT between children treated with part-time patching and those under observation.
Main Methods:
- A multicenter, randomized clinical trial was conducted involving 201 children aged 12 to 35 months with untreated IXT.
- Participants were randomly assigned to either observation or part-time patching (3 hours daily for 5 months, followed by 1 month off).
- The primary outcome measure was deterioration, defined as constant exotropia (≥10 prism diopters) at distance and near, or requiring non-protocol treatment.
Main Results:
- Deterioration occurred in 4.6% of the observation group and 2.2% of the patching group (P=0.27) over 6 months.
- Motor deterioration rates were similar between groups (2.3% observation vs. 2.2% patching, P=0.55).
- Mean exodeviation at distance was significantly reduced in the patching group (24.9Δ vs. 27.9Δ, P=0.02), but not at near (17.0Δ vs. 19.3Δ, P=0.10).
Conclusions:
- Deterioration of IXT over 6 months was uncommon in young children, regardless of part-time patching treatment.
- There is insufficient evidence to support the routine use of part-time patching for treating IXT in children aged 12 to 35 months.
- Further research may be needed to identify subgroups that could benefit from patching therapy.
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.
