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To assess impact of near and distance spectacles on reducing rates of cognitive decline with aging in community dwelling older people in India

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 - CLEVER

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/02/040074
Enrollment
760
Registered
2022-02-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z000- Encounter for general adult medical examination

Interventions

Intervention1: Free near and distance glasses: Safely and inexpensively corrected with spectacles, refractive errors are the most common and easily treated cause of vision loss. The correction of near

Sponsors

Queens University Belfast
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: i. (= 60 years at the time of randomisation ii. Community-dwelling iii. Residency: Participants must plan to reside in the local area for the study duration. iv. Impaired distance ( v. Willingness to participate, be randomized and adhere to the protocol

Exclusion criteria

Exclusion criteria: (i) Impaired baseline cognition (HMSE score = 18); (ii) Non-refractive cause(s) of vision impairment; (iii) Severely impaired mobility (immobile/bedridden/wheelchair/using walker) (iv) Severe medical illness including cardiac and hepatic failure, advanced kidney disease, malignancies, major neurological illnesses, major psychiatric conditions and/or other conditions that affect life span or preclude cognitive testing. (v) Hearing loss: Fail in Whisper test hearing screening(Unable to repeat three out of six words)

Design outcomes

Primary

MeasureTime frame
(i) Name of the outcome: Change in cognition (ii) The metric or method of measurement to be used: LASI-DAD global cognitive score (iii) Timepoint(s) of primary interest: 36 months Timepoint: (i) Name of the outcome: Change in cognition (ii) The metric or method of measurement to be used: LASI-DAD global cognitive score (iii) Timepoint(s) of primary interest: 36 months

Secondary

MeasureTime frame
Quality of life, Falls, depression, glasses compliance, cost effectiveness, social interaction/isolation, self-reported physical activity. (ii) The metric or method of measurement to be used: Domain-specific cognitive function Quality of life: WHOQOL BREF Falls: Quick screen Depression: PHQ9 Cost effectiveness Eyeglasses adherence: Self report & observation by study personnel Social interaction/isolation: Social Networking Index Self-reported physical activity: International Physical Activity Questionnaire (IPAQ). (iii) Time point(s) of primary interest: 36 months, with primary & secondary outcomes collected every 12 months – ie at 12, 24 & 36 months Timepoint: 1 year, 2 year, 3 year

Countries

India

Contacts

Public ContactDrRohit Khanna

Principal Investigator

rohit@lvpei.org08790855857

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026