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Remote follow-up after cataract surgery (CORE-RCT): study protocol of a randomized controlled trial
BACKGROUND: Cataract surgery has become one of the most performed surgical procedures worldwide. Postoperative management consists of routine clinical examinations to assess post-operative visual function and detect possible adverse events. Due to the low incidence of complications, the majority of...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9885558/ https://www.ncbi.nlm.nih.gov/pubmed/36717799 http://dx.doi.org/10.1186/s12886-023-02779-7 |
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author | Claessens, Janneau L. J. Wanten, Joukje C. Bauer, Noël J. C. Nuijts, Rudy M. M. A. Findl, Oliver Huemer, Josef Imhof, Saskia M. Wisse, Robert P. L. |
author_facet | Claessens, Janneau L. J. Wanten, Joukje C. Bauer, Noël J. C. Nuijts, Rudy M. M. A. Findl, Oliver Huemer, Josef Imhof, Saskia M. Wisse, Robert P. L. |
author_sort | Claessens, Janneau L. J. |
collection | PubMed |
description | BACKGROUND: Cataract surgery has become one of the most performed surgical procedures worldwide. Postoperative management consists of routine clinical examinations to assess post-operative visual function and detect possible adverse events. Due to the low incidence of complications, the majority of clinic visits after cataract surgery are uneventful. Nonetheless, valuable time and hospital resources are consumed. We hypothesize that remote post-operative follow-up involving teleconsultations and self-assessments of visual function and health status, could be a valid alternative to face-to-face clinical examinations in selected patient groups. The practice of remote follow-up after cataract surgery has not yet been evaluated. The aim of this study is to investigate the validity, safety and cost-effectiveness of remote cataract surgery follow-up, and to report on the patients’ experiences with remotely self-assessing visual function. METHODS: This study is a multicenter, open-label, randomized controlled trial. Patients planned for cataract surgery on both eyes, without ocular comorbidities, are eligible for participation. Participants will be allocated (1:1) into one of the two study groups: ‘telemonitoring’ or ‘usual care’. Participants in the ‘telemonitoring’ group will perform in-home assessments after cataract surgery (remote web-based eye exams and digital questionnaires on their own devices). Participants in the ‘usual care’ group will have regular post-operative consultations, according to the study site’s regular practice. Outcome measures include accuracy of the web-based eye exam for assessing visual acuity and refraction, patient-reported outcome measures (visual function and quality of life), adverse events, and cost aspects. DISCUSSION: Investigating remote follow-up after cataract surgery fits the current trends of digitization of health care. We believe that remote self-care can be a promising avenue to comply with the increasing demands of cataract care. This randomized controlled trial provides scientific evidence on this unmet need and delivers the desired insights on (cost)effectiveness of remote follow-up after cataract surgery. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04809402. Date of registration: March 22, 2021. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12886-023-02779-7. |
format | Online Article Text |
id | pubmed-9885558 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-98855582023-01-31 Remote follow-up after cataract surgery (CORE-RCT): study protocol of a randomized controlled trial Claessens, Janneau L. J. Wanten, Joukje C. Bauer, Noël J. C. Nuijts, Rudy M. M. A. Findl, Oliver Huemer, Josef Imhof, Saskia M. Wisse, Robert P. L. BMC Ophthalmol Study Protocol BACKGROUND: Cataract surgery has become one of the most performed surgical procedures worldwide. Postoperative management consists of routine clinical examinations to assess post-operative visual function and detect possible adverse events. Due to the low incidence of complications, the majority of clinic visits after cataract surgery are uneventful. Nonetheless, valuable time and hospital resources are consumed. We hypothesize that remote post-operative follow-up involving teleconsultations and self-assessments of visual function and health status, could be a valid alternative to face-to-face clinical examinations in selected patient groups. The practice of remote follow-up after cataract surgery has not yet been evaluated. The aim of this study is to investigate the validity, safety and cost-effectiveness of remote cataract surgery follow-up, and to report on the patients’ experiences with remotely self-assessing visual function. METHODS: This study is a multicenter, open-label, randomized controlled trial. Patients planned for cataract surgery on both eyes, without ocular comorbidities, are eligible for participation. Participants will be allocated (1:1) into one of the two study groups: ‘telemonitoring’ or ‘usual care’. Participants in the ‘telemonitoring’ group will perform in-home assessments after cataract surgery (remote web-based eye exams and digital questionnaires on their own devices). Participants in the ‘usual care’ group will have regular post-operative consultations, according to the study site’s regular practice. Outcome measures include accuracy of the web-based eye exam for assessing visual acuity and refraction, patient-reported outcome measures (visual function and quality of life), adverse events, and cost aspects. DISCUSSION: Investigating remote follow-up after cataract surgery fits the current trends of digitization of health care. We believe that remote self-care can be a promising avenue to comply with the increasing demands of cataract care. This randomized controlled trial provides scientific evidence on this unmet need and delivers the desired insights on (cost)effectiveness of remote follow-up after cataract surgery. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04809402. Date of registration: March 22, 2021. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12886-023-02779-7. BioMed Central 2023-01-30 /pmc/articles/PMC9885558/ /pubmed/36717799 http://dx.doi.org/10.1186/s12886-023-02779-7 Text en © The Author(s) 2023 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 Claessens, Janneau L. J. Wanten, Joukje C. Bauer, Noël J. C. Nuijts, Rudy M. M. A. Findl, Oliver Huemer, Josef Imhof, Saskia M. Wisse, Robert P. L. Remote follow-up after cataract surgery (CORE-RCT): study protocol of a randomized controlled trial |
title | Remote follow-up after cataract surgery (CORE-RCT): study protocol of a randomized controlled trial |
title_full | Remote follow-up after cataract surgery (CORE-RCT): study protocol of a randomized controlled trial |
title_fullStr | Remote follow-up after cataract surgery (CORE-RCT): study protocol of a randomized controlled trial |
title_full_unstemmed | Remote follow-up after cataract surgery (CORE-RCT): study protocol of a randomized controlled trial |
title_short | Remote follow-up after cataract surgery (CORE-RCT): study protocol of a randomized controlled trial |
title_sort | remote follow-up after cataract surgery (core-rct): study protocol of a randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9885558/ https://www.ncbi.nlm.nih.gov/pubmed/36717799 http://dx.doi.org/10.1186/s12886-023-02779-7 |
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