Actively Recruiting

Phase Not Applicable
Age: 60Years +
All Genders
NCT05458323

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

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Trial Site Locations

Total: 1 location

1

L V Prasad Eye Institute

Hyderabad, Telangana, India, 500086

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here