Srinivas Marmamula, Suvarna Alladi, Keerthana Umapathy, Ving Fai Chan, Graeme MacKenzie, Lynne Lohfeld, Asha Latha Mettla, Sridevi Rayasam, Vijaya K Gothwal, Raja Narayanan, Giridhar Pyda, Harithaa P Chadalavada, Priya Thomas, Lovemore Nyasha Sigwadhi, Augusto Azuara-Blanco, Cliona McDowell, Susan McMullan, Lynn Murphy, Mike Clarke, Joshua R Ehrlich, Bonnielin Sweenor, Ciaran O'Neill, Shashidhar Komaravolu, Pallab K Maulik, G V S Murthy, Keshav Kumar, Anant Nyshadham, Achyuta Adhvaryu, Christopher McCabe, David E Bloom, Jinkook Lee, Frank Lin, Seán Coghlan, Rohit C Khanna, Nathan Congdon
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引用次数: 0
Abstract
Background: Longitudinal observational studies have found an association between vision impairment and accelerated decline in cognition. However, no randomised trials have assessed the possible benefit of vision correction on cognitive change. We present the protocol for a three-year randomised controlled trial designed to assess the impact of spectacles for distance and/or near vision correction on cognitive change among community-dwelling elderly participants in India.
Methods: Cognitive Level Enhancement through Vision Exams and Refraction (CLEVER) is a single-centre, open-label, parallel-group, individually-randomised trial. Participants (760 total, 380 in each arm) aged ≥ 60 years with correctable vision impairment at distance and/or near (presenting visual acuity < 6/18 in the better-seeing eye and improving to > = 6/18 with spectacles and/or presenting near vision worse than N6 at 40 cm and improving to N6 with spectacles), normal hearing (able to repeat at least three out of six words whispered from a 50 cm distance in the better ear) and normal cognition (Hindi Mini-mental Status Examination score > 18/31) will be enrolled. After a comprehensive eye examination, intervention group participants will receive distance, near, or bifocal spectacles, while controls will receive a prescription and spectacles at the end of the trial. The primary outcome will be the three-year change in Longitudinal Aging Study in India-Diagnostic Assessment of Dementia (LASI DAD) global cognitive factor score, with and without adjustment for baseline score, age, gender, education and other potential confounders.
Conclusion: CLEVER is designed to assess the effectiveness of spectacles as a low-cost intervention to prevent or delay cognitive decline.
Trial registration: This trial is registered with ClinicalTrials.gov, number NCT05458323, February 15, 2023.
期刊介绍：
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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