Cognitive Level Enhancement Through Vision Exams and Refraction

Summary

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

• Refractive Errors

Interventions

DEVICE

Free near and Distance Vision glasses

Intervention Description: All participants randomised to the intervention group will be provided with free near and/or distance spectacles based on the results of refraction.Glasses will be provided at the time of enrolment in the study.

Sponsors & Collaborators

• L.V. Prasad Eye Institute

  collaborator OTHER

• National Institute of Mental Health and Neuro Sciences, India

  collaborator OTHER

• The George Institute

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• Clearly

  collaborator OTHER

• Belfast Health and Social Care Trust

  collaborator OTHER

• Queen's University, Belfast

  lead OTHER

Principal Investigators

• Nathan G Congdon, MD, MPH · Queen's University, Belfast

• Rohit C Khanna, MPH · L.V. Prasad Eye Institute

• Suvarna Alladi, DM · National Institute of Mental Health and Neuro Sciences, India

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-18

Primary Completion

2027-11-30

Completion

2028-12-31

Countries

• India

Study Locations