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NCT05458323: CLEVER
Cognitive Level Enhancement Through Vision Exams and Refraction
NA trial testing Free near and Distance Vision glasses in Refractive Errors in 820 participants. Currently enrolling.
30 November 2027
Quick facts
| Lead sponsor | Queen's University, Belfast |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 820 |
| Start date | 18 January 2024 |
| Primary completion | 30 November 2027 |
| Estimated completion | 31 December 2028 |
| Sites | 1 location across India |
Drugs / interventions tested
- Free near and Distance Vision glasses
Conditions studied
- Refractive Errors — all drugs for Refractive Errors →
Sponsor
Queen's University, Belfast
Who can join
60 and older, any sex, with Refractive Errors. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Cognitive Level Enhancement through Vision Exams and Refraction (CLEVER): study protocol for a randomised controlled trial.
Marmamula S, Alladi S, Umapathy K, Chan VF, et al · · 2025 · cited 1× · PMID 40156032 · DOI 10.1186/s13063-025-08813-x
Verify or expand the search:
- PubMed search for NCT05458323
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Refractive Errors
Currently open trials in the same condition.
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- NCT07001124 — Comparative Efficacy of Duochrome Test Verse +1 Blur Test in Detecting Refracting Error Across Different Ages · NA · active not recruiting
- NCT06668246 — Performance of Refractometers With Self-adjusting Lenses Compared to Cycloplegia in Children (REFRALENS) · active not recruiting
- NCT05550740 — Repeated Low-Level Red-Light Therapy for Shortening Axial Length · NA · active not recruiting
Other Queen's University, Belfast trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05458323 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Queen's University, Belfast
- Last refreshed: 6 March 2026
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing