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

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

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)2299-2310
Number of pages12
JournalOphthalmology
Volume121
Issue number12
DOIs
StatePublished - Dec 1 2014

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

ASJC Scopus subject areas

  • Ophthalmology

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A randomized trial comparing part-time patching with observation for children 3 to 10 years of age with intermittent exotropia. / Cotter, Susan A.; Mohney, Brian G.; Chandler, Danielle L.; Holmes, Jonathan M.; Repka, Michael X; Melia, Michele; Wallace, David K.; Beck, Roy W.; Birch, Eileen E.; Kraker, Raymond T.; Tamkins, Susanna M.; Miller, Aaron M.; Sala, Nicholas A.; Glaser, Stephen R.

In: Ophthalmology, Vol. 121, No. 12, 01.12.2014, p. 2299-2310.

Research output: Contribution to journalArticle

Cotter, SA, Mohney, BG, Chandler, DL, Holmes, JM, Repka, MX, Melia, M, Wallace, DK, Beck, RW, Birch, EE, Kraker, RT, Tamkins, SM, Miller, AM, Sala, NA & Glaser, SR 2014, 'A randomized trial comparing part-time patching with observation for children 3 to 10 years of age with intermittent exotropia', Ophthalmology, vol. 121, no. 12, pp. 2299-2310. https://doi.org/10.1016/j.ophtha.2014.07.021
Cotter, Susan A. ; Mohney, Brian G. ; Chandler, Danielle L. ; Holmes, Jonathan M. ; Repka, Michael X ; Melia, Michele ; Wallace, David K. ; Beck, Roy W. ; Birch, Eileen E. ; Kraker, Raymond T. ; Tamkins, Susanna M. ; Miller, Aaron M. ; Sala, Nicholas A. ; Glaser, Stephen R. / A randomized trial comparing part-time patching with observation for children 3 to 10 years of age with intermittent exotropia. In: Ophthalmology. 2014 ; Vol. 121, No. 12. pp. 2299-2310.
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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.",
author = "Cotter, {Susan A.} and Mohney, {Brian G.} and Chandler, {Danielle L.} and Holmes, {Jonathan M.} and Repka, {Michael X} and Michele Melia and Wallace, {David K.} and Beck, {Roy W.} and Birch, {Eileen E.} and Kraker, {Raymond T.} and Tamkins, {Susanna M.} and Miller, {Aaron M.} and Sala, {Nicholas A.} and Glaser, {Stephen R.}",
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T1 - A randomized trial comparing part-time patching with observation for children 3 to 10 years of age with intermittent exotropia

AU - Cotter, Susan A.

AU - Mohney, Brian G.

AU - Chandler, Danielle L.

AU - Holmes, Jonathan M.

AU - Repka, Michael X

AU - Melia, Michele

AU - Wallace, David K.

AU - Beck, Roy W.

AU - Birch, Eileen E.

AU - Kraker, Raymond T.

AU - Tamkins, Susanna M.

AU - Miller, Aaron M.

AU - Sala, Nicholas A.

AU - Glaser, Stephen R.

PY - 2014/12/1

Y1 - 2014/12/1

N2 - 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.

AB - 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.

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