Remote follow-up after cataract surgery (CORE-RCT): study protocol of a randomized controlled trial
Abstract 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 majo...
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| Format: | Article |
| Language: | English |
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BMC
2023-01-01
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| Series: | BMC Ophthalmology |
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| Online Access: | https://doi.org/10.1186/s12886-023-02779-7 |
| _version_ | 1811171837192699904 |
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| author | Janneau L. J. Claessens Joukje C. Wanten Noël J. C. Bauer Rudy M. M. A. Nuijts Oliver Findl Josef Huemer Saskia M. Imhof Robert P. L. Wisse |
| author_facet | Janneau L. J. Claessens Joukje C. Wanten Noël J. C. Bauer Rudy M. M. A. Nuijts Oliver Findl Josef Huemer Saskia M. Imhof Robert P. L. Wisse |
| author_sort | Janneau L. J. Claessens |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-04-10T17:20:48Z |
| format | Article |
| id | doaj.art-a208468373234792be00c064dd727aee |
| institution | Directory Open Access Journal |
| issn | 1471-2415 |
| language | English |
| last_indexed | 2024-04-10T17:20:48Z |
| publishDate | 2023-01-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Ophthalmology |
| spelling | doaj.art-a208468373234792be00c064dd727aee2023-02-05T12:07:15ZengBMCBMC Ophthalmology1471-24152023-01-012311710.1186/s12886-023-02779-7Remote follow-up after cataract surgery (CORE-RCT): study protocol of a randomized controlled trialJanneau L. J. Claessens0Joukje C. Wanten1Noël J. C. Bauer2Rudy M. M. A. Nuijts3Oliver Findl4Josef Huemer5Saskia M. Imhof6Robert P. L. Wisse7Department of Ophthalmology, University Medical Center UtrechtUniversity Eye Clinic Maastricht, Maastricht University Medical Center+University Eye Clinic Maastricht, Maastricht University Medical Center+University Eye Clinic Maastricht, Maastricht University Medical Center+Vienna Institute for Research in Ocular Surgery, a Karl Landsteiner Institute, Hanusch HospitalVienna Institute for Research in Ocular Surgery, a Karl Landsteiner Institute, Hanusch HospitalDepartment of Ophthalmology, University Medical Center UtrechtDepartment of Ophthalmology, University Medical Center UtrechtAbstract 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.https://doi.org/10.1186/s12886-023-02779-7CataractE-healthTelemedicineRemote careEye careEasee |
| spellingShingle | Janneau L. J. Claessens Joukje C. Wanten Noël J. C. Bauer Rudy M. M. A. Nuijts Oliver Findl Josef Huemer Saskia M. Imhof Robert P. L. Wisse Remote follow-up after cataract surgery (CORE-RCT): study protocol of a randomized controlled trial BMC Ophthalmology Cataract E-health Telemedicine Remote care Eye care Easee |
| 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 | Cataract E-health Telemedicine Remote care Eye care Easee |
| url | https://doi.org/10.1186/s12886-023-02779-7 |
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