Three-Year Observation of Children 3 to 10 Years of Age with Untreated Intermittent Exotropia

The Pediatric Eye Disease Investigator Group

Research output: Contribution to journalArticle

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Abstract

Purpose: To describe the course of intermittent exotropia (IXT) in children followed up without treatment for 3 years. Design: Observation arm from randomized trial of short-term occlusion versus observation. Participants: One hundred eighty-three children 3 to 10 years of age with previously untreated IXT and 400 seconds of arc (arcsec) or better near stereoacuity. Methods: Participants were to receive no treatment unless deterioration criteria were met at a follow-up visit occurring at 3 months, 6 months, or 6-month intervals thereafter for 3 years. Main Outcome Measures: The primary outcome was deterioration by 3 years, defined as meeting motor criterion (constant exotropia ≥10 prism diopters [Δ] at distance and near) or near stereoacuity criterion (≥2-octave decrease from best previous measure). For the primary analysis, participants also were considered to have deteriorated if treatment was prescribed without meeting either deterioration criterion. Results: The cumulative probability of protocol-specified deterioration by 3 years was 15% (95% confidence interval, 10%–22%), but that was likely an overestimate, partly because of misclassification. Among 25 deteriorations, 2 met motor deterioration, 11 met stereoacuity deterioration, and 12 started treatment without meeting either criteria (7 for social concern, 1 for diplopia, 4 for other reasons). Among the 132 participants who completed the 3-year visit and had not been treated during the study, only 1 (<1%) met motor or stereoacuity deterioration criteria at 3 years. Of the 4 participants completing the 3-year visit who met deterioration criteria previously and had not started treatment, none still met deterioration criteria. Between the baseline and 3-year examination for these 132 patients, improvement occurred in distance and near stereoacuity (mean improvement, 0.14 and 0.14 logarithm of arcsec; P ≤ 0.001 and P ≤ 0.001, respectively), distance exotropia control (mean improvement, 0.6 points; P ≤ 0.001), and distance exodeviation magnitude (mean improvement, 2.2 Δ; P = 0.002). Conclusions: Among children 3 to 10 years of age with IXT for whom surgery was not considered to be the immediately necessary treatment, stereoacuity deterioration or progression to constant exotropia over 3 years was uncommon, and exotropia control, stereoacuity, and magnitude of deviation remained stable or improved slightly.

Original languageEnglish (US)
JournalOphthalmology
DOIs
StatePublished - Jan 1 2019

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Exotropia
Observation
Therapeutics
Diplopia
Outcome Assessment (Health Care)
Confidence Intervals

ASJC Scopus subject areas

  • Ophthalmology

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Three-Year Observation of Children 3 to 10 Years of Age with Untreated Intermittent Exotropia. / The Pediatric Eye Disease Investigator Group.

In: Ophthalmology, 01.01.2019.

Research output: Contribution to journalArticle

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title = "Three-Year Observation of Children 3 to 10 Years of Age with Untreated Intermittent Exotropia",
abstract = "Purpose: To describe the course of intermittent exotropia (IXT) in children followed up without treatment for 3 years. Design: Observation arm from randomized trial of short-term occlusion versus observation. Participants: One hundred eighty-three children 3 to 10 years of age with previously untreated IXT and 400 seconds of arc (arcsec) or better near stereoacuity. Methods: Participants were to receive no treatment unless deterioration criteria were met at a follow-up visit occurring at 3 months, 6 months, or 6-month intervals thereafter for 3 years. Main Outcome Measures: The primary outcome was deterioration by 3 years, defined as meeting motor criterion (constant exotropia ≥10 prism diopters [Δ] at distance and near) or near stereoacuity criterion (≥2-octave decrease from best previous measure). For the primary analysis, participants also were considered to have deteriorated if treatment was prescribed without meeting either deterioration criterion. Results: The cumulative probability of protocol-specified deterioration by 3 years was 15{\%} (95{\%} confidence interval, 10{\%}–22{\%}), but that was likely an overestimate, partly because of misclassification. Among 25 deteriorations, 2 met motor deterioration, 11 met stereoacuity deterioration, and 12 started treatment without meeting either criteria (7 for social concern, 1 for diplopia, 4 for other reasons). Among the 132 participants who completed the 3-year visit and had not been treated during the study, only 1 (<1{\%}) met motor or stereoacuity deterioration criteria at 3 years. Of the 4 participants completing the 3-year visit who met deterioration criteria previously and had not started treatment, none still met deterioration criteria. Between the baseline and 3-year examination for these 132 patients, improvement occurred in distance and near stereoacuity (mean improvement, 0.14 and 0.14 logarithm of arcsec; P ≤ 0.001 and P ≤ 0.001, respectively), distance exotropia control (mean improvement, 0.6 points; P ≤ 0.001), and distance exodeviation magnitude (mean improvement, 2.2 Δ; P = 0.002). Conclusions: Among children 3 to 10 years of age with IXT for whom surgery was not considered to be the immediately necessary treatment, stereoacuity deterioration or progression to constant exotropia over 3 years was uncommon, and exotropia control, stereoacuity, and magnitude of deviation remained stable or improved slightly.",
author = "{The Pediatric Eye Disease Investigator Group} and Mohney, {Brian G.} and Cotter, {Susan A.} and Chandler, {Danielle L.} and Holmes, {Jonathan M} and Wallace, {David K.} and Tomohiko Yamada and Petersen, {David B.} and Kraker, {Raymond T.} and Morse, {Christie L.} and Melia, {B. Michele} and Rui Wu",
year = "2019",
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language = "English (US)",
journal = "Ophthalmology",
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AU - The Pediatric Eye Disease Investigator Group

AU - Mohney, Brian G.

AU - Cotter, Susan A.

AU - Chandler, Danielle L.

AU - Holmes, Jonathan M

AU - Wallace, David K.

AU - Yamada, Tomohiko

AU - Petersen, David B.

AU - Kraker, Raymond T.

AU - Morse, Christie L.

AU - Melia, B. Michele

AU - Wu, Rui

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Purpose: To describe the course of intermittent exotropia (IXT) in children followed up without treatment for 3 years. Design: Observation arm from randomized trial of short-term occlusion versus observation. Participants: One hundred eighty-three children 3 to 10 years of age with previously untreated IXT and 400 seconds of arc (arcsec) or better near stereoacuity. Methods: Participants were to receive no treatment unless deterioration criteria were met at a follow-up visit occurring at 3 months, 6 months, or 6-month intervals thereafter for 3 years. Main Outcome Measures: The primary outcome was deterioration by 3 years, defined as meeting motor criterion (constant exotropia ≥10 prism diopters [Δ] at distance and near) or near stereoacuity criterion (≥2-octave decrease from best previous measure). For the primary analysis, participants also were considered to have deteriorated if treatment was prescribed without meeting either deterioration criterion. Results: The cumulative probability of protocol-specified deterioration by 3 years was 15% (95% confidence interval, 10%–22%), but that was likely an overestimate, partly because of misclassification. Among 25 deteriorations, 2 met motor deterioration, 11 met stereoacuity deterioration, and 12 started treatment without meeting either criteria (7 for social concern, 1 for diplopia, 4 for other reasons). Among the 132 participants who completed the 3-year visit and had not been treated during the study, only 1 (<1%) met motor or stereoacuity deterioration criteria at 3 years. Of the 4 participants completing the 3-year visit who met deterioration criteria previously and had not started treatment, none still met deterioration criteria. Between the baseline and 3-year examination for these 132 patients, improvement occurred in distance and near stereoacuity (mean improvement, 0.14 and 0.14 logarithm of arcsec; P ≤ 0.001 and P ≤ 0.001, respectively), distance exotropia control (mean improvement, 0.6 points; P ≤ 0.001), and distance exodeviation magnitude (mean improvement, 2.2 Δ; P = 0.002). Conclusions: Among children 3 to 10 years of age with IXT for whom surgery was not considered to be the immediately necessary treatment, stereoacuity deterioration or progression to constant exotropia over 3 years was uncommon, and exotropia control, stereoacuity, and magnitude of deviation remained stable or improved slightly.

AB - Purpose: To describe the course of intermittent exotropia (IXT) in children followed up without treatment for 3 years. Design: Observation arm from randomized trial of short-term occlusion versus observation. Participants: One hundred eighty-three children 3 to 10 years of age with previously untreated IXT and 400 seconds of arc (arcsec) or better near stereoacuity. Methods: Participants were to receive no treatment unless deterioration criteria were met at a follow-up visit occurring at 3 months, 6 months, or 6-month intervals thereafter for 3 years. Main Outcome Measures: The primary outcome was deterioration by 3 years, defined as meeting motor criterion (constant exotropia ≥10 prism diopters [Δ] at distance and near) or near stereoacuity criterion (≥2-octave decrease from best previous measure). For the primary analysis, participants also were considered to have deteriorated if treatment was prescribed without meeting either deterioration criterion. Results: The cumulative probability of protocol-specified deterioration by 3 years was 15% (95% confidence interval, 10%–22%), but that was likely an overestimate, partly because of misclassification. Among 25 deteriorations, 2 met motor deterioration, 11 met stereoacuity deterioration, and 12 started treatment without meeting either criteria (7 for social concern, 1 for diplopia, 4 for other reasons). Among the 132 participants who completed the 3-year visit and had not been treated during the study, only 1 (<1%) met motor or stereoacuity deterioration criteria at 3 years. Of the 4 participants completing the 3-year visit who met deterioration criteria previously and had not started treatment, none still met deterioration criteria. Between the baseline and 3-year examination for these 132 patients, improvement occurred in distance and near stereoacuity (mean improvement, 0.14 and 0.14 logarithm of arcsec; P ≤ 0.001 and P ≤ 0.001, respectively), distance exotropia control (mean improvement, 0.6 points; P ≤ 0.001), and distance exodeviation magnitude (mean improvement, 2.2 Δ; P = 0.002). Conclusions: Among children 3 to 10 years of age with IXT for whom surgery was not considered to be the immediately necessary treatment, stereoacuity deterioration or progression to constant exotropia over 3 years was uncommon, and exotropia control, stereoacuity, and magnitude of deviation remained stable or improved slightly.

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