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Cognitive Level Enhancement Through Vision Exams and Refraction

Eligible age

60+ yrs

Accepts

All genders

Locations

0 states

Healthy volunteers

No

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About this study

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.

Sponsor: Queen's University, Belfast

You may qualify if…

  • 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

You may not qualify if…

  • 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

Source: ClinicalTrials.gov · NCT05458323 · last updated 2026-03-06

Cognitive Level Enhancement Through Vision Exams and Refraction · TrialPath