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 Tamkins, Aaron M. Miller, Nicholas A. Sala, Stephen R. Glaser

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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.

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

Cite this

Cotter, S. A., Mohney, B. G., Chandler, D. L., Holmes, J. M., Repka, M. X., Melia, M., ... Glaser, S. R. (2014). A randomized trial comparing part-time patching with observation for children 3 to 10 years of age with intermittent exotropia. Ophthalmology, 121(12), 2299-2310. https://doi.org/10.1016/j.ophtha.2014.07.021

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; 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, S, 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 ; 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.",
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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

AU - Miller, Aaron M.

AU - Sala, Nicholas A.

AU - Glaser, Stephen R.

PY - 2014/12/1

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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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