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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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.
背景：纵向观察研究发现视力损害与认知能力加速下降之间存在关联。然而，没有随机试验评估视力矫正对认知改变的可能益处。我们提出了一项为期三年的随机对照试验的方案，该试验旨在评估眼镜用于远距离和/或近距离视力矫正对印度社区老年人参与者认知变化的影响。方法：通过视力检查和屈光增强认知水平（CLEVER）是一项单中心、开放标签、平行组、个体随机试验。参与者（共760人，每组380人）年龄≥60岁，在远处和/或近处有可矫正视力障碍（戴眼镜时视力为6/18，戴眼镜时近视力低于N6，戴眼镜后视力改善至N6），听力正常（在50厘米处较好的耳朵能重复至少3个单词），认知正常（印地语最低精神状态检查分数为> 18/31）。在进行全面的眼科检查后，干预组参与者将获得远视、近视或双光眼镜，而对照组在试验结束时将获得处方和眼镜。主要结果将是印度纵向老龄化研究（Longitudinal Aging Study in india）痴呆诊断评估（LASI DAD）全球认知因素评分的三年变化，包括基线评分、年龄、性别、教育程度和其他潜在混杂因素的调整。结论：CLEVER旨在评估眼镜作为一种低成本干预措施预防或延缓认知能力下降的有效性。试验注册：该试验已于2023年2月15日在ClinicalTrials.gov注册，编号NCT05458323。
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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