An interventional study of Free near and Distance Vision glasses in Refractive Errors, sponsored by Queen's University, Belfast. Active, not recruiting at 1 site in India. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Queen's University, Belfast · Not applicable, Interventional, and Treatment
Among 10 studies in Refractive Errors with a site in India — 2 open to participants now, 3 under way, none of them phase 3. Refractive Errors · India.
Among the 10 studies in Refractive Errors with a site in India, this one is one of 2 that started in 2024, is one of 9 with no phase, and was the 7th registered.
420 studies on the registry are indexed under Refractive Errors; 59 are open to participants now.
This study's enrollment of 821 is above the median of 76 across 301 interventional studies indexed under Refractive Errors.
Browse Refractive Errors studies →2 of the 10 studies in Refractive Errors with a site in India are open now, in 1 country. Each count lists the studies.
Of the 30 Refractive Errors studies recruiting now, 8 (27%) set no upper age limit and 19 (63%) stop at 75 or younger; 16 take children under 18; 18 take healthy volunteers.
This study: 60 Years and older · all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 2 started in 2024.
Median enrollment 682 across the 9 interventional studies, 150 across the 1 observational. Of the 7 that completed or were terminated, 1 (14%) have results posted.
2 of 10 have an industry lead sponsor. The 7 most frequent:
Queen's University, Belfast is the lead sponsor of 117 studies on the registry; 14 are open to participants now.
Queen's University, Belfast has 6 studies filed under Refractive Errors — fewer than ten, so there is no comparison to draw.
2 of the studies in Refractive Errors with a site in India that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06996353London Vision ClinicClinical Data Collection of Myopic Patients After PTK-PRK With CZM MEL 90 Excimer Laser | 2026-11 |
| NCT07333248Seva Canada SocietyStrengthening Community- to- Hospital Eye Care Pathways From Boko Eye Care Center in Rural Assam | 2027-01-31 |
Among the 10 studies in Refractive Errors with a site in India, from their registry updates:
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.
The number of people living with dementia globally will rise from 50 million in 2017 to 131.5 million by 2050. The majority reside in low and middle-income countries (LMICs), where a 223% increase in the burden of dementia is expected from 2015 to 2050. The household cost of caring for demented relatives in India was £2.48 billion in 2013, where total expenses for dementia care will soon consume 0.5% of Gross Domestic Product (GDP). Despite the rapidly-growing burden of dementia in India, only 1 in 10 affected are diagnosed or treated. Proven preventive strategies are desperately needed to close the gap, and could reduce incidence by an estimated 41%, especially early, at the stage of mild cognitive impairment, which itself increases risk of dementia by 23-fold. Existing interventions have predominantly been evaluated in high-income countries (HIC), despite the acknowledged need for prevention in low resource settings. India's national dementia strategy, documented in the Alzheimer's and Related Society of India (ARDSI) Report (2018) and Dementia in India (2020), echo the WHO Dementia Global Action Plan (2017) in prioritising evidence-based approaches to reduce risk.
The elderly, at greatest risk for cognitive disorders, also have the highest prevalence of vision impairment, which affects 2.2 billion persons globally. Growing longitudinal evidence links vision impairment and risk of cognitive decline, with population studies in the United States reporting a 55% increased 9-year risk of new cognitive impairment among visually impaired persons. Longitudinal studies elsewhere in the United States, France, Singapore and China report similar results. While vision impairment is a strong predictor of future cognitive performance, cognition is relatively weakly linked to future visual decline. Both distance impairment and impairment of near vision, a nearly universal part of aging without refractive correction, have been implicated. Observational studies also suggest vision care slows rates of cognitive decline by up to 50%. The association between vision loss and cognitive decline and dementia, while consistent and strong, is not well understood, and various causal pathways have been posited. These include common neurodegenerative or micro vascular aetiology, increased cognitive load, and limited social contact and physical activity due to poor vision, each independently shown to elevate risk of dementia. Studies investigating the role of vision correction in slowing cognitive decline will have a significant impact in developing strategies to reduce the burden of dementia.
Design: single centre, open label, two-arm, parallel group, stratified, interventional randomised trial with a qualitative component Rationale: Despite considerable longitudinal observational evidence, there have been no randomised trials to investigate whether providing near and distance glasses can slow cognitive decline in the elderly. Proof of a causative association between vision correction and the slowing of cognitive decline is needed to potentiate investment in inexpensive vision care for prevention. This requires randomised trials, and none have yet been done.
Study Plan:
Eligibility assessments conducted for 5000-10000 participants. After providing the consent and meeting the eligibility criteria, 820 participants randomised to intervention and control groups.
HbA1C and information about oral health will be collected from the participants in the follow-up visits.
Annual follow-ups for 3 years for both groups. Home visits will be done for those participants who requested a home visit and who otherwise cannot participate.
Cataract follow up: Along with annual visits and the spectacle compliance contacts, follow-up would also be done for those participants who are advised for cataract surgery and efforts would be made to ensure they get the cataract surgery done. This surgery would be done at no cost to the patient.
Lost to follow ups documented with reason for both groups. Missed data for both groups will be analysed as intention to treat (ITT) analysis.
Statistical methods: The change in LASI-DAD global cognitive score between baseline and 36 months will be compared between the intervention and control groups. A linear mixed model will be used to estimate the overall change in LASI-DAD global cognitive score over-time adjusting for potential determinants of change in cognitive status, such as baseline cognitive score, age, gender, education level, occupation, quality of life, depression, social interaction, and physical activity. Restricted maximum likelihood estimation (REML) will be used as the estimation method. If the LASI-DAD global cognitive score is skewed, the log transformation will be used and if the data contains zero, the square root transformations will be done (since the log of zero is undefined). The log transformation is mainly preferred for its ease use and interpretability. The mean change score (and its 95% CI) will be reported for 12 months versus baseline and 24 months versus baseline, and 36 months versus baseline. Significance tests will be two-sided with 5% level of significance and reported using overall Wald p-values for linear regression. All continuous outcomes (INDVFQ, IPAQ, PHQ9, HMSE scores) will be analysed following the same procedure as the main outcome. SNI (categorical ) will be analysed using the multinomial logistic regression. Further details will be provided in the SAP
The trial anticipates two intercurrent events: (i) cataract surgery and (ii) cataract development with refusal of surgery. The primary estimand uses a treatment policy strategy including all patients regardless of cataract status or surgery. The secondary estimand uses a treatment policy for surgery and a hypothetical strategy for refusal, censoring at refusal.
Justification for sample size: Imputing three-year un-intervened decline in the outcome variable (LASI-DAD global score from cross-sectional, age-stratified data, at 29% effect size (from the ACHIEVE study), 502 participants give 90% power at p = 0.05 (two-tailed) based on a two-sample test. With annual follow-up loss of 13% based on estimation from previous studies conducted in India and WHO annual mortality rates in the elderly Indian population (ranging between 10.1 % and 12.7 %) a total of 760 participants is required.
To align with the estimands framework, and to account for intercurrent events that may impact outcome assessment (e.g. loss to follow-up, the development of cataract or competing risks), the sample size was further adjusted. Assuming 7% missing data for the intercurrent events and using the formula by Fang and Jin (2021), 820 total participants are needed across the two study groups. This ensures appropriate power for the primary analysis under a missing-at-random assumption.
With 60% prevalence of uncorrected distance and/or near refractive error, the total number of people needing to be screened is estimated at approximately 1370. However, based on available and other local factors as evident from pre-pilot work, 5,000-10,000 participants may have to be screened for recruiting 820 participants for the trial.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Willingness
Exclusion criteria
Impaired baseline cognition
a. HMSE score less than or equal to 18
Severely impaired mobility
Severe medical illness likely to limit the life span
Hearing loss assessment
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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.
Device: Free near and Distance Vision glasses
All 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.
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.
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 frame: Time point(s) of primary interest: 36 months collected at 12, 24 and 36 months
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 frame: Time point(s) of primary interest: 36 months collected every 12 months - ie at 12, 24 and 36 months
Cost effectiveness
The metric or method of measurement to be used: Cost-effectiveness using Client Service Receipt Inventory
Time frame: Time point(s) of primary interest: 36 months collected every 12 months - ie at 12, 24 and 36 months
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 frame: Time point(s) of primary interest: 36 months collected every 12 months - ie at 12, 24 and 36 months
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 frame: Time point(s) of primary interest: 36 months collected every 12 months - ie at 12, 24 and 36 months
Falls risk
The metric or method of measurement to be used: Quick Screen Clinical Falls Risk Assessment: 12-month probability of falling (%), where higher scores indicate greater risk. The instrument classifies risk into four bands (7%, 13%, 27%, 49%).
Time frame: Time point(s) of primary interest: 36 months collected every 12 months - ie at Baseline, 12, 24 and 36 months
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 frame: Time point(s) of primary interest: 36 months collected every 12 months - ie at 12, 24 and 36 months
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 frame: Time point(s) of primary interest: 36 months collected every 12 months - ie at 12, 24 and 36 months
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 frame: Time point(s) of primary interest: 36 months collected every 12 months - ie at 12, 24 and 36 months
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 frame: Time point(s) of primary interest: 36 months collected every 12 months - ie at 12, 24 and 36 months
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: All deidentified IPD will be available from publication of the primary results until 10 years after the end of the trial.
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
Started Jan 2024 (actual). Primary completion is estimated for Nov 2028, 58 months after the start.
Of 57 non-industry interventional studies with no phase under Refractive Errors, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 47. This study's planned 58 months is above that.
Counting every sponsor, half of 172 studies reached it within 7 months; a quarter within 2 and three quarters within 23.
Primary completion moved once since we started tracking on Sep 25, 2026: Nov 2027 → Nov 2028, on Nov 9, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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