Refractive Errors Clinical Trial
— CLEVEROfficial title:
Cognitive Level Enhancement Through Vision Exams and Refraction: a Randomized Controlled Trial to Assess Impact of Near and Distance Spectacles on Reducing Rates of Cognitive Decline With Aging in Community Dwelling Older People in India
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: Domain-specific cognitive function (orientation, executive function, language/fluency, memory), quality of life (WHOQOL BREF), self-reported visual functioning (INDVFQ), falls, mobility, depression (PHQ9), glasses compliance, cost-effectiveness (total intervention cost per additional quality-adjusted life years(QALY) gained in the intervention group), social interaction/isolation (Social Networking Index, SNI), self-reported physical activity (GPAQ). An additional secondary outcome will be LASI-DAD global cognitive score analysed by excluding any tests determined pre-hoc to depend on visual acuity.
Status | Recruiting |
Enrollment | 760 |
Est. completion date | December 31, 2028 |
Est. primary completion date | November 30, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria 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. Presenting vision in the better eye due to under-corrected refractive error 1. Impaired distance vision less than 6/18 2. Near vision less than N6 at 40 cm 5. Willingness 1. to participate 2. to be randomized 3. to adhere to the protocol Exclusion criteria 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 4. Severe medical illness likely to limit the life span 1. Cancer 2. Heart disease 3. Stroke 4. HIV or AIDS 5. Chronic lung disease 6. Kidney disease 5. Hearing loss assessment 1. self-reported hearing impairment 2. inability to hear 3. fail in whisper test hearing screening(unable to repeat three out of six words) |
Country | Name | City | State |
---|---|---|---|
India | L V Prasad Eye Institute | Hyderabad | Telangana |
Lead Sponsor | Collaborator |
---|---|
Queen's University, Belfast | Belfast Health and Social Care Trust, Clearly, Johns Hopkins University, L.V. Prasad Eye Institute, National Institute of Mental Health and Neuro Sciences, India, The George Institute, University of Michigan |
India,
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* Note: There are 54 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in cognitive score | The metric or method of measurement to be used: LASI-DAD global cognitive score. The best possible score is 360 and the worst possible score is 0. | Time point(s) of primary interest: 36 months collected at 12, 24 and 36 months | |
Secondary | 26-Item Quality of Life | The metric or method of measurement to be used: Quality of Life using WHO BREF questionnaire. Higher scores (for 4 domains) indicate higher quality of life and vice versa (it is a continuum) | Time point(s) of primary interest: 36 months collected every 12 months - ie at 12, 24 and 36 months | |
Secondary | Cost effectiveness | The metric or method of measurement to be used: Cost-effectiveness using Client Service Receipt Inventory | Time point(s) of primary interest: 36 months collected every 12 months - ie at 12, 24 and 36 months | |
Secondary | Social interaction/isolation | The metric or method of measurement to be used: Social Networking Index. The best possible score is 12 and the worst possible score is 0 | Time point(s) of primary interest: 36 months collected every 12 months - ie at 12, 24 and 36 months | |
Secondary | Self-reported physical activity. | The metric or method of measurement to be used: International Physical Activity Questionnaire Self-reported physical activity: International Physical Activity Questionnaire (IPAQ). | Time point(s) of primary interest: 36 months collected every 12 months - ie at 12, 24 and 36 months | |
Secondary | Falls | The metric or method of measurement to be used: Quick Screen for falls Risk. The worst possible score is 7% and the best possible score is 49% | Time point(s) of primary interest: 36 months collected every 12 months - ie at 12, 24 and 36 months | |
Secondary | Depression | The metric or method of measurement to be used: Patient Health Questionnaire, PHQ9. Worst score is 0 and best possible score is 27 | Time point(s) of primary interest: 36 months collected every 12 months - ie at 12, 24 and 36 months | |
Secondary | Glasses compliance | The metric or method of measurement to be used: Use of glasses during follow-up visits. The best possible score is 1 and the worst possible score is 0 | Time point(s) of primary interest: 36 months collected every 12 months - ie at 12, 24 and 36 months | |
Secondary | Visual Function | The metric or method of measurement to be used: Indian VFQ. The measure will be in logits (using Rasch-scaled interval scores) and it is a continuum with positive person scores indicating lower visual functioning and negative scores indicating better visual functioning. | Time point(s) of primary interest: 36 months collected every 12 months - ie at 12, 24 and 36 months | |
Secondary | Domain-specific cognitive function | The metric or method of measurement to be used: Hindi Mental State Examination. The best possible score is 31 and the worst possible score is 0. | Time point(s) of primary interest: 36 months collected every 12 months - ie at 12, 24 and 36 months |
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