NCT05458323 Cognitive Level Enhancement Through Vision Exams and Refraction
| NCT ID | NCT05458323 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Queen's University, Belfast |
| Condition | Refractive Errors |
| Study Type | INTERVENTIONAL |
| Enrollment | 820 participants |
| Start Date | 2024-01-18 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 820 participants in total. It began in 2024-01-18 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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. 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)
Contact & Investigator
Nathan G Congdon, MD, MPH
PRINCIPAL INVESTIGATOR
Queen's University, Belfast
Frequently Asked Questions
Who can join the NCT05458323 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Refractive Errors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05458323 currently recruiting?
Yes, NCT05458323 is actively recruiting participants. Contact the research team at n.congdon@qub.ac.uk for enrollment information.
Where is the NCT05458323 trial being conducted?
This trial is being conducted at Hyderabad, India.
Who is sponsoring the NCT05458323 clinical trial?
NCT05458323 is sponsored by Queen's University, Belfast. The principal investigator is Nathan G Congdon, MD, MPH at Queen's University, Belfast. The trial plans to enroll 820 participants.