Actively Recruiting
Cognitive Level Enhancement Through Vision Exams and Refraction
Led by Queen's University, Belfast · Updated on 2026-03-06
820
Participants Needed
1
Research Sites
258 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
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 LASI- DAD (Longitudinal Aging Study in India(LASI)- Diagnostic Assessment of Dementia(DAD) global cognitive score. Secondary Outcome Measures: Three year change in Quality of Life score measured by WHO QOL-BREF; Visual functioning from the RASCH-scaled version of INDVFQ(Indian Visual Functioning(INDVFQ);self-reported physical activity score measured using IPAQ questionnaire; PHQ9 score; domain specific cognitive score (orientation, executive function, language/fluency, memory) measured by HMSE; Total cost of care including direct and indirect costs; Quality adjusted life years; Incremental Cost Effectiveness Ratio; Number of falls measured by Quick Screen score over the three years; Social network density at 3 years (SNI 1-3 represents a "limited" social network, 4-5 is a "medium" social network, and SNI ≥6 is a "diverse" social network) measured by the SNI score; An additional secondary outcome will be LASI-DAD global cognitive score analysed by excluding any tests determined pre-hoc to depend on visual acuity.
CONDITIONS
Official Title
Cognitive Level Enhancement Through Vision Exams and Refraction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Community dwelling
- Plans to live in the local area for the study duration
- Presenting vision in better eye with uncorrected refractive error: distance vision worse than 6/18 or near vision worse than N6 at 40 cm
- Willing to participate in the study
- Willing to be randomized
- Willing to follow the study protocol
You will not qualify if you...
- Baseline cognitive impairment with HMSE score 18 or below
- Vision impairment caused by non-refractive issues
- Severe mobility problems including being immobile, bedridden, or using a wheelchair or walker
- Serious medical illnesses likely to reduce life span such as cancer, heart disease, stroke, HIV/AIDS, chronic lung disease, or kidney disease
- Hearing loss indicated by self-report, inability to hear, or failing a whisper test
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
L V Prasad Eye Institute
Hyderabad, Telangana, India, 500086
Actively Recruiting
Research Team
N
Nathan G Congdon, MD, MPH
CONTACT
R
Rohit C Khanna, MPH
CONTACT
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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