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Cognitive Level Enhancement Through Vision Exams and Refraction

RecruitingNAAges 60 Years - anyAllQueen's University, Belfast
NCT05458323 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The investigators aim to conduct a mixed-method study in which a randomised controlled trial (RCT) and a descriptive qualitative study will be conducted. The RCT aims to determine whether free near and distance glasses provided to residents in Hyderabad, India, aged ≥ 60 years, with under- or un- corrected refractive error and normal baseline hearing and cognition (HMSE \> 18), can improve quality of life, reduce falls, reduce depression, improve social interaction and physical activity cost-effectively over 36 months. The primary qualitative research aim is to a) contextualize the RCT with information on the milieu and culture in which the trial will be conducted; b) provide data on the lived experiences of older adults with reduced vision in the study area, and c) conduct a process evaluation of the trial. The primary outcome measure is the three-year change in cognition measured by L

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📋 Eligibility rules (as published)
Inclusion Criteria 1. Community dwelling 2. Residency a. Participants must plan to reside in the local area for the study duration 3. Presenting vision in the better eye due to uncorrected refractive error 1. Impaired distance vision less than 6/18 2. Near vision less than N6 at 40 cm 4. Willingness 1. to participate 2. to be randomized 3. to adhere to the protocol Exclusion criteria 1. Impaired baseline cognition a. HMSE score less than or equal to 18 2. Non-refractive causes of vision impairment 3. Severely impaired mobility 1. immobile 2. bedridden 3. wheelchair 4. using walker 4. Severe medical illness likely to limit the life span 1. Cancer 2. Heart disease 3. Stroke 4. HIV or AIDS 5. Chronic lung disease 6. Kidney disease 5. Hearing loss assessment 1. self-reported hearing impairment 2. inability to hear 3. fail in whisper test hearing screening(unable to repeat three out of six words)
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What it tests

  • Free near and Distance Vision glasses
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Where

1 site
L V Prasad Eye Institute
Hyderabad, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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