Brian G Mohney1, Susan A Cotter2, Danielle L Chandler3, Jonathan M Holmes4, Angela M Chen2, Michele Melia3, Sean P Donahue5, David K Wallace6, Raymond T Kraker3, Melanie L Christian7, Donny W Suh8. 1. Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota. Electronic address: pedig@jaeb.org. 2. Southern California College of Optometry at Marshall B. Ketchum University, Fullerton, California. 3. Jaeb Center for Health Research, Tampa, Florida. 4. Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota. 5. Vanderbilt Eye Center, Nashville, Tennessee. 6. Duke Eye Center, Durham, North Carolina. 7. Concord Ophthalmologic Associates, Concord, Ohio. 8. Wolfe Clinic, West Des Moines, Iowa.
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.
RCT Entities:
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 participantsin the observation group and in 2.2% (2 of 90) of the participantsin 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 inchildrenin this age group.
Authors: Susan A Cotter; Brian G Mohney; Danielle L Chandler; Jonathan M Holmes; Michael X Repka; Michele Melia; David K Wallace; Roy W Beck; Eileen E Birch; Raymond T Kraker; Susanna M Tamkins; Aaron M Miller; Nicholas A Sala; Stephen R Glaser Journal: Ophthalmology Date: 2014-09-16 Impact factor: 12.079
Authors: Rosanne Superstein; Trevano W Dean; Jonathan M Holmes; Danielle L Chandler; Susan A Cotter; David K Wallace; B Michele Melia; Raymond T Kraker; R Grey Weaver; Brian G Mohney; Sean P Donahue; Eileen E Birch Journal: J AAPOS Date: 2017-06-28 Impact factor: 1.220