Cognitive Level Enhancement Through Vision Exams and Refraction
CLEVER
1 other identifier
interventional
820
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2022
CompletedFirst Posted
Study publicly available on registry
July 14, 2022
CompletedStudy Start
First participant enrolled
January 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
March 6, 2026
March 1, 2026
3.9 years
July 11, 2022
March 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
26-Item Quality of Life
Time point(s) of primary interest: 36 months collected every 12 months - ie at 12, 24 and 36 months
Cost effectiveness
Time point(s) of primary interest: 36 months collected every 12 months - ie at 12, 24 and 36 months
Social interaction/isolation
Time point(s) of primary interest: 36 months collected every 12 months - ie at 12, 24 and 36 months
Self-reported physical activity.
Time point(s) of primary interest: 36 months collected every 12 months - ie at 12, 24 and 36 months
Falls
Time point(s) of primary interest: 36 months collected every 12 months - ie at 12, 24 and 36 months
- +4 more secondary outcomes
Study Arms (2)
Free near and distance glasses
EXPERIMENTALAll 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 into the study. The participants will be asked to choose from an assortment of 20 frames. Participants will be asked to report to the study team member in case of any issue with spectacles or if spectacles are lost or broken. Replacement glasses will be provided in case of broken or lost spectacles whenever required. Participants will undergo annual eye exams and refraction, and change of glasses will be prescribed as needed.
Control-No treatment
NO INTERVENTIONAll participants randomised to the control group will receive a prescription for spectacles and given free near and/or distance glasses as needed at study close out.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Community dwelling
- Residency
- a. Participants must plan to reside in the local area for the study duration
- Presenting vision in the better eye due to uncorrected refractive error
- Impaired distance vision less than 6/18
- Near vision less than N6 at 40 cm
- Willingness
- to participate
- to be randomized
- to adhere to the protocol
You may not qualify if:
- Impaired baseline cognition
- a. HMSE score less than or equal to 18
- Non-refractive causes of vision impairment
- Severely impaired mobility
- immobile
- bedridden
- wheelchair
- using walker
- Severe medical illness likely to limit the life span
- Cancer
- Heart disease
- Stroke
- HIV or AIDS
- Chronic lung disease
- Kidney disease
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Queen's University, Belfastlead
- L.V. Prasad Eye Institutecollaborator
- National Institute of Mental Health and Neuro Sciences, Indiacollaborator
- The George Institutecollaborator
- Johns Hopkins Universitycollaborator
- University of Michigancollaborator
- Clearlycollaborator
- Belfast Health and Social Care Trustcollaborator
Study Sites (1)
L V Prasad Eye Institute
Hyderabad, Telangana, 500086, India
Related Publications (1)
Marmamula S, Alladi S, Umapathy K, Chan VF, MacKenzie G, Lohfeld L, Mettla AL, Rayasam S, Gothwal VK, Narayanan R, Pyda G, Chadalavada HP, Thomas P, Sigwadhi LN, Azuara-Blanco A, McDowell C, McMullan S, Murphy L, Clarke M, Ehrlich JR, Sweenor B, O'Neill C, Komaravolu S, Maulik PK, Murthy GVS, Kumar K, Nyshadham A, Adhvaryu A, McCabe C, Bloom DE, Lee J, Lin F, Coghlan S, Khanna RC, Congdon N. Cognitive Level Enhancement through Vision Exams and Refraction (CLEVER): study protocol for a randomised controlled trial. Trials. 2025 Mar 28;26(1):109. doi: 10.1186/s13063-025-08813-x.
PMID: 40156032RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nathan G Congdon, MD, MPH
Queen's University, Belfast
- PRINCIPAL INVESTIGATOR
Rohit C Khanna, MPH
L.V. Prasad Eye Institute
- PRINCIPAL INVESTIGATOR
Suvarna Alladi, DM
National Institute of Mental Health and Neuro Sciences, India
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 11, 2022
First Posted
July 14, 2022
Study Start
January 18, 2024
Primary Completion (Estimated)
November 30, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
March 6, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- All deidentified IPD will be available from September 2022 (anticipated Trial start date) to September 2035 (inclusive of analysis, publication and archival).
- Access Criteria
- Following publication of the primary and secondary outcomes there may be scope to conduct additional analyses on the data collected. In such instances formal requests for data will need to be made in writing to the Chief Investigator, who will discuss this with the Sponsor. The study will comply with the good practice principles for sharing individual participant data from publicly funded clinical trials and data sharing will be undertaken in accordance with the required regulatory requirements
All Individual Participant Data(IPD) will be stored in anonymised format. The IPD that includes personal identifiable information will be deleted when the data collection process is complete and before the initiation of data analysis. Only de-identified data will be shared with all the researchers for analysis. The primary analysis will be conducted on all outcome data obtained from all enrolled participants as randomised.