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

Brian G. Mohney, Susan A. Cotter, Danielle L. Chandler, Jonathan M Holmes, Angela M. Chen, Michele Melia, Sean P. Donahue, David K. Wallace, Raymond T. Kraker, Melanie L. Christian, Donny W. Suh

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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.

Original languageEnglish (US)
Pages (from-to)1718-1725
Number of pages8
JournalOphthalmology
Volume122
Issue number8
DOIs
StatePublished - Aug 1 2015

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Exotropia
Observation
Confidence Intervals
Therapeutics
Randomized Controlled Trials
Age Groups
Outcome Assessment (Health Care)

ASJC Scopus subject areas

  • Ophthalmology

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A Randomized Trial Comparing Part-time Patching with Observation for Intermittent Exotropia in Children 12 to 35 Months of Age. / Mohney, Brian G.; Cotter, Susan A.; Chandler, Danielle L.; Holmes, Jonathan M; Chen, Angela M.; Melia, Michele; Donahue, Sean P.; Wallace, David K.; Kraker, Raymond T.; Christian, Melanie L.; Suh, Donny W.

In: Ophthalmology, Vol. 122, No. 8, 01.08.2015, p. 1718-1725.

Research output: Contribution to journalArticle

Mohney, BG, Cotter, SA, Chandler, DL, Holmes, JM, Chen, AM, Melia, M, Donahue, SP, Wallace, DK, Kraker, RT, Christian, ML & Suh, DW 2015, 'A Randomized Trial Comparing Part-time Patching with Observation for Intermittent Exotropia in Children 12 to 35 Months of Age', Ophthalmology, vol. 122, no. 8, pp. 1718-1725. https://doi.org/10.1016/j.ophtha.2015.04.025
Mohney, Brian G. ; Cotter, Susan A. ; Chandler, Danielle L. ; Holmes, Jonathan M ; Chen, Angela M. ; Melia, Michele ; Donahue, Sean P. ; Wallace, David K. ; Kraker, Raymond T. ; Christian, Melanie L. ; Suh, Donny W. / A Randomized Trial Comparing Part-time Patching with Observation for Intermittent Exotropia in Children 12 to 35 Months of Age. In: Ophthalmology. 2015 ; Vol. 122, No. 8. pp. 1718-1725.
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title = "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.",
author = "Mohney, {Brian G.} and Cotter, {Susan A.} and Chandler, {Danielle L.} and Holmes, {Jonathan M} and Chen, {Angela M.} and Michele Melia and Donahue, {Sean P.} and Wallace, {David K.} and Kraker, {Raymond T.} and Christian, {Melanie L.} and Suh, {Donny W.}",
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T1 - A Randomized Trial Comparing Part-time Patching with Observation for Intermittent Exotropia in Children 12 to 35 Months of Age

AU - Mohney, Brian G.

AU - Cotter, Susan A.

AU - Chandler, Danielle L.

AU - Holmes, Jonathan M

AU - Chen, Angela M.

AU - Melia, Michele

AU - Donahue, Sean P.

AU - Wallace, David K.

AU - Kraker, Raymond T.

AU - Christian, Melanie L.

AU - Suh, Donny W.

PY - 2015/8/1

Y1 - 2015/8/1

N2 - 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.

AB - 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.

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