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Effects of orthoptic therapy in children with intermittent exotropia after surgery: study protocol for a randomized controlled trial

BACKGROUND: Intermittent exotropia (IXT) is the most common type of exotropia in China. Surgery is usually required to align the eye deviation to maintain or obtain better binocular visual function. However, there is a high rate of exodrift or recurrence in surgically treated patients. Orthoptic the...

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Autores principales: Xu, Meiping, Zheng, Fuhao, Peng, Yiyi, Wang, Chunxiao, Lou, Jiangtao, Yu, Huanyun, Wang, Yuwen, Yu, Xinping
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8996411/
https://www.ncbi.nlm.nih.gov/pubmed/35410367
http://dx.doi.org/10.1186/s13063-022-06246-4
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author Xu, Meiping
Zheng, Fuhao
Peng, Yiyi
Wang, Chunxiao
Lou, Jiangtao
Yu, Huanyun
Wang, Yuwen
Yu, Xinping
author_facet Xu, Meiping
Zheng, Fuhao
Peng, Yiyi
Wang, Chunxiao
Lou, Jiangtao
Yu, Huanyun
Wang, Yuwen
Yu, Xinping
author_sort Xu, Meiping
collection PubMed
description BACKGROUND: Intermittent exotropia (IXT) is the most common type of exotropia in China. Surgery is usually required to align the eye deviation to maintain or obtain better binocular visual function. However, there is a high rate of exodrift or recurrence in surgically treated patients. Orthoptic therapy is sometimes recommended for IXT patients after surgery. However, there is a lack of high-quality randomized controlled trials to prove that orthoptic therapy could be an effective supplement to surgical treatment for IXT patients. The main purpose of this study is to test the clinical effectiveness of orthoptic therapy in long-term stabilization of postoperative IXT patient. This report describes the design and methodology of the Intermittent Exotropia Postoperative Treatment Clinical Trial, which is the first large-sample, blank-controlled, randomized clinical trial. METHODS: A total of 136 IXT patients (aged 7 to 17 years) will be enrolled and assigned to the orthoptic therapy group or blank control group according to a simple randomization scheme. Patients in the orthoptic therapy group will receive at least 2 months of orthoptic therapy, such as anti-suppression, vergence, and accommodation training. Patients in the blank control group will receive only refractive correction. All enrolled patients will need regular follow-up observation until 24 months after surgery. The primary outcome will be the proportion of participants meeting suboptimal surgical outcomes in this 24-month follow-up, which is defined as (1) exodeviation of 10 prism diopters (PD) at distance or near using the simultaneous prism and cover test (SPCT) or (2) loss of 2 or more octaves of stereoacuity from baseline, at any masked follow-up visit examination. The secondary outcomes will be the exodeviation at distance and near using the simultaneous prism and alternate cover test (PACT), magnitude of fusional convergence, stereoacuity, and accommodation. Measurements will be taken at baseline and at the 6-, 12-, 18-, and 24-month follow-ups. DISCUSSION: To the best of our knowledge, this will be the first prospective, randomized controlled study of orthoptic training in IXT patients after surgery. The aim of this work is to confirm the efficacy of orthoptic therapy in reducing the proportion of recurrence among IXT patients after surgery and improving binocular vision function. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1900026891. Registered on 25 October 2019.
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spelling pubmed-89964112022-04-12 Effects of orthoptic therapy in children with intermittent exotropia after surgery: study protocol for a randomized controlled trial Xu, Meiping Zheng, Fuhao Peng, Yiyi Wang, Chunxiao Lou, Jiangtao Yu, Huanyun Wang, Yuwen Yu, Xinping Trials Study Protocol BACKGROUND: Intermittent exotropia (IXT) is the most common type of exotropia in China. Surgery is usually required to align the eye deviation to maintain or obtain better binocular visual function. However, there is a high rate of exodrift or recurrence in surgically treated patients. Orthoptic therapy is sometimes recommended for IXT patients after surgery. However, there is a lack of high-quality randomized controlled trials to prove that orthoptic therapy could be an effective supplement to surgical treatment for IXT patients. The main purpose of this study is to test the clinical effectiveness of orthoptic therapy in long-term stabilization of postoperative IXT patient. This report describes the design and methodology of the Intermittent Exotropia Postoperative Treatment Clinical Trial, which is the first large-sample, blank-controlled, randomized clinical trial. METHODS: A total of 136 IXT patients (aged 7 to 17 years) will be enrolled and assigned to the orthoptic therapy group or blank control group according to a simple randomization scheme. Patients in the orthoptic therapy group will receive at least 2 months of orthoptic therapy, such as anti-suppression, vergence, and accommodation training. Patients in the blank control group will receive only refractive correction. All enrolled patients will need regular follow-up observation until 24 months after surgery. The primary outcome will be the proportion of participants meeting suboptimal surgical outcomes in this 24-month follow-up, which is defined as (1) exodeviation of 10 prism diopters (PD) at distance or near using the simultaneous prism and cover test (SPCT) or (2) loss of 2 or more octaves of stereoacuity from baseline, at any masked follow-up visit examination. The secondary outcomes will be the exodeviation at distance and near using the simultaneous prism and alternate cover test (PACT), magnitude of fusional convergence, stereoacuity, and accommodation. Measurements will be taken at baseline and at the 6-, 12-, 18-, and 24-month follow-ups. DISCUSSION: To the best of our knowledge, this will be the first prospective, randomized controlled study of orthoptic training in IXT patients after surgery. The aim of this work is to confirm the efficacy of orthoptic therapy in reducing the proportion of recurrence among IXT patients after surgery and improving binocular vision function. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1900026891. Registered on 25 October 2019. BioMed Central 2022-04-11 /pmc/articles/PMC8996411/ /pubmed/35410367 http://dx.doi.org/10.1186/s13063-022-06246-4 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Xu, Meiping
Zheng, Fuhao
Peng, Yiyi
Wang, Chunxiao
Lou, Jiangtao
Yu, Huanyun
Wang, Yuwen
Yu, Xinping
Effects of orthoptic therapy in children with intermittent exotropia after surgery: study protocol for a randomized controlled trial
title Effects of orthoptic therapy in children with intermittent exotropia after surgery: study protocol for a randomized controlled trial
title_full Effects of orthoptic therapy in children with intermittent exotropia after surgery: study protocol for a randomized controlled trial
title_fullStr Effects of orthoptic therapy in children with intermittent exotropia after surgery: study protocol for a randomized controlled trial
title_full_unstemmed Effects of orthoptic therapy in children with intermittent exotropia after surgery: study protocol for a randomized controlled trial
title_short Effects of orthoptic therapy in children with intermittent exotropia after surgery: study protocol for a randomized controlled trial
title_sort effects of orthoptic therapy in children with intermittent exotropia after surgery: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8996411/
https://www.ncbi.nlm.nih.gov/pubmed/35410367
http://dx.doi.org/10.1186/s13063-022-06246-4
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