Cognitive Level Enhancement through Vision Exams and Refraction (CLEVER): study protocol for a randomised controlled trial.
Srinivas Marmamula, Suvarna Alladi, Keerthana Umapathy...
https://pubmed.ncbi.nlm.nih.gov/40156032Actively Recruiting
Phase Not Applicable
Age: 60Years +
All Genders
ID05458323
Cognitive Level Enhancement Through Vision Exams and Refraction: a Randomized Trial Assessing Impact of Free Near and Distance Glasses on Cognitive Decline in Older Adults in India
Led by Queen's University, Belfast · Updated on 2026-03-06
820
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
Q
Queen's University, Belfast
Lead Sponsor
L
L.V. Prasad Eye Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether providing free near and distance glasses to older adults in Hyderabad, India, aged 60 years and above, with under- or uncorrected vision problems can improve their quality of life and slow cognitive decline. This mixed-method study combines a randomized controlled trial (RCT) with a qualitative component to understand the cultural context and lived experiences of participants with reduced vision. The study also aims to assess the impact of vision correction on reducing falls, depression, social isolation, and physical activity over a period of 36 months. Participants are randomly assigned to one of two groups. Those in the intervention group receive free spectacles for near and/or distance vision at the start of the study, with options to choose from 20 frames. They will have annual eye exams and refractions to adjust or replace glasses as needed. The control group receives prescriptions and free glasses only at the end of the study. Cataract surgery is provided at no cost for those recommended during follow-ups. Annual assessments continue for three years, including home visits for participants unable to attend clinic visits. During the study, participants undergo evaluations of cognitive function, quality of life, visual functioning, physical activity, depression, social interactions, cost of care, and number of falls. Researchers use various questionnaires and cognitive tests at baseline and every 12 months until 36 months. The study also tracks compliance with spectacle use and cataract surgery outcomes. Safety and follow-up data, including reasons for any loss to follow-up, are carefully recorded to support comprehensive analysis of the intervention's effects.
CONDITIONS
Brief Title
Cognitive Level Enhancement Through Vision Exams and Refraction
Who Can Participate
Age: 60Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Community dwelling older adults
- Plan to reside in the local area for the study duration
- Presenting vision impairment due to uncorrected refractive error with distance vision worse than 6/18 or near vision less than N6 at 40 cm
- Willing to participate, be randomized, and follow the study protocol
You will not qualify if you...
- Baseline cognitive impairment with HMSE score 18 or lower
- Vision loss due to causes other than refractive error
- Severe mobility impairment such as being immobile, bedridden, using wheelchair or walker
- Severe medical illnesses likely to limit lifespan including cancer, heart disease, stroke, HIV/AIDS, chronic lung or kidney disease
- Hearing loss as self-reported, inability to hear, or failure on whisper test hearing screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - At enrollment and ongoing as needed
Participants who are randomized to the intervention group receive free near and/or distance vision glasses based on refraction results. Glasses are provided at enrollment. Participants are asked to report any issues or if glasses are lost or broken, with replacements provided as needed.
1 baseline visit with additional visits as needed for glasses replacement
Monitoring
Duration - Annual follow-ups for 3 years
Participants undergo annual eye exams and refraction, with changes in glasses prescribed as needed. The study also includes annual follow-up visits for cognitive and other assessments, with home visits offered for participants unable to attend in person.
Annual visits for up to 3 years with possible home visits
Cataract Follow-up
Duration - Up to 3 years during follow-up
Participants advised for cataract surgery are followed up to support getting surgery done at no cost. Spectacle compliance contacts also occur during follow-up.
Additional follow-up contacts as needed for cataract surgery and spectacle compliance
Trial Site Locations
Total: 1 location
1
L V Prasad Eye Institute
Hyderabad, Telangana, India, 500086
Actively Recruiting
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Research Team
N
Nathan G Congdon, MD, MPH
R
Rohit C Khanna, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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