AzTrials
AzTrials

Cognition DisordersCLEVERNCT06836440

Impact of Glasses for Vision Problems on Cognitive Function in Rural Older Adults

A study testing Free Prescription Glasses in people with Cognition Disorders, run by Yuju Wu at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aim of this project is to explore whether vision correction can effectively slow cognitive decline in older adults. The primary question it seeks to answer is: Can providing free near and/or distance vision correction glasses to older adults with refractive errors or uncorrected vision, who have normal baseline… Read more about this study

Who is it for?
Ages 60 to 79 yearsHealthy volunteers can take part
Conditions the study is for
Cognition Disorders
What is being tested?
Free Prescription Glasses
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
964 participants
Where
1 siteChina
Study dates
10 Nov 2025to 31 Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 79 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Older adults who meet all of the following criteria will be eligible to participate in this study:
  • Registered as a rural resident (holding rural household registration);
  • Age from 60 to 79 years at the time of enumeration;
  • Resident in the household for > = 3 months and planning to reside in the local area for the trial duration;
  • Distance vision impairment (VI, presenting visual acuity [VA] < 6/12 in the better-seeing eye and improving to ≥ 6/7.5 or better in either eye with spectacle correction) and/or near VI (presenting near VA < 6/12 at 40 cm when measured binocularly and improving to ≥ 6/7.5 or better in either eye with near correction);
  • Independent mobility with or without the support of a walking stick;
  • Chinese version of the Mini-Mental State Examination (C-MMSE) score above the following cut-offs (out of 30): >17 for illiterate participants, >20 for those with primary school education, >22 for those with junior high school education, and >23 for those with high school education or above.
  • Willingness to participate, to be randomized to either study group, and to adhere to the protocol

Who cannot join

  • Presence of glaucoma or visually significant cataract, or a history of surgical treatment for these or other major ocular conditions;
  • Consistent use of prescription spectacles and/or hearing aids;
  • Serious medical illness likely to result in loss to follow-up. Those less severely affected by conditions such as hypertension and/or diabetes will be eligible;
  • Failure on the whispered voice hearing screening test in the better ear (unable to repeat > = 3 out of 6 words whispered from behind the participant at a distance of 50 cm);

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yuju Wu contact

86+18382096899

yujuwu@scu.edu.cn

China1 site, 1 recruiting

  • Community health service centers

    Ya'an, Sichuan, 610065

    Yuju Yingjing County Health Commission, 0835-7623834, yujuwu@scu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: The Impact of Spectacle Intervention for Refractive Error and Presbyopia on Cognitive Function in Rural Older Adults

The aim of this project is to explore whether vision correction can effectively slow cognitive decline in older adults.

The primary question it seeks to answer is: Can providing free near and/or distance vision correction glasses to older adults with refractive errors or uncorrected vision, who have normal baseline cognition and hearing, reduce the rate of cognitive decline over 36 months in a cost-effective manner? Researchers will compare the rate of cognitive decline over 36 months between older adults who receive refractive correction and those who do not.

Read the detailed description

Exploratory subgroup analyses will be conducted to assess whether the intervention effect on cognitive decline differs according to baseline vision correction needs (near vision correction, distance vision correction, or both) and baseline cognitive function. These analyses will be interpreted cautiously due to their exploratory nature.

Being tested
Free Prescription Glasses
Medical subject headings
Cognition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Free Prescription GlassesDevice

    Participants can choose from a variety of frames, and the research team will customize the glasses according to their pupillary distance and prescription. Once the glasses are ready, they will be provided to the participants following standard usage instructions. In case of loss or damage, participants should report it to the project team and will be provided with replacement glasses as needed. Each year, participants in the intervention group will undergo an eye exam to assess changes in vision, and their glasses prescription will be updated if necessary.

Study groups in NCT06836440
Study groupRoleWhat they receive
Free Prescription Glasses Intervention groupExperimentalAll participants randomly assigned to the intervention group will receive free near or distance vision correction glasses based on their refractive error. Participants can choose from a variety of frames, and the research team will customize the glasses according to their pupillary distance and prescription. Once the glasses are ready, they will be provided to the participants following standard usage instructions. In case of loss or damage, participants should report it to the project team and will be provided with replacement glasses as needed. Each year, participants in the intervention group will undergo an eye exam to assess changes in vision, and their glasses prescription will be updated if necessary.
Receives: Device: Free Prescription Glasses
Prescription-Only Control groupNo interventionAll participants randomly assigned to the control group will receive an eyeglass prescription, but free glasses will not be provided during the study. At the end of the study, the research team will provide near or distance vision correction glasses free of charge based on the needs of the control group participants.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in global cognitive function

    The primary outcome will be the change in global cognitive function from baseline to the 36-month follow-up, assessed by the total score of the Chinese version of the Montreal Cognitive Assessment Basic (MoCA-BC) . The MoCA-BC was selected because it minimizes reading and writing requirements and has been widely used in China, allowing for reliable cognitive assessment among individuals who are illiterate or have limited formal education.

    Measured: Baseline to 12, 24, and 36 months

Secondary outcomes (8)

  1. Change in domain-specific cognitive function

    Secondary outcomes include domain-specific cognitive performance derived from a composite cognitive battery based on the China Health and Retirement Longitudinal Study (CHARLS) cognitive assessments. The CHARLS-based cognitive battery comprises a set of task-based cognitive assessments, such as measures of orientation, episodic memory, verbal fluency, and executive function. These tasks rely primarily on oral responses, making them particularly suitable for participants with uncorrected refractive errors, for whom visually demanding tasks may be challenging.

    Measured: Baseline to 12, 24, and 36 months

  2. Change in falls risk

    Falls risk will be assessed using the prespecified falls-risk assessment included in the study protocol.

    Measured: Baseline to 12, 24, and 36 months

  3. Change in vision-related quality of life

    Vision-related quality of life will be assessed using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25).

    Measured: Baseline to 12, 24, and 36 months

  4. Change in health-related quality of life

    Health-related quality of life will be assessed using the EQ-5D-5L.

    Measured: Baseline to 12, 24, and 36 months

  5. Change in depressive symptoms

    Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire (PHQ-9).

    Measured: Baseline to 12, 24, and 36 months

  6. Change in physical activity

    Physical activity will be assessed using the short form of the International Physical Activity Questionnaire (IPAQ-SF)

    Measured: Baseline to 12, 24, and 36 months

  7. Change in social network

    Social network will be assessed using the Lubben Social Network Scale-6 (LSNS-6)

    Measured: Baseline to 12, 24, and 36 months

  8. Cost-effectiveness of the intervention

    Cost-effectiveness will be expressed as the incremental cost per quality-adjusted life year (QALY) gained in the intervention group compared with the control group. Costs will include healthcare service utilization and associated costs assessed using CSRI-adapted items and productivity-related information collected using the WPAI. QALYs will be derived from EQ-5D-5L utility scores.

    Measured: From baseline through 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2025
  2. Study start10 Nov 2025
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
964 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06836440
Sponsor's protocol ID
HXSY-BEC-S2026005
Acronym
CLEVER
Status last verified
Sep 2026
First submitted
12 Feb 2025
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be publicly available due to ethical and privacy considerations. The collected data contain sensitive health information, and sharing individual-level data may pose risks to participant confidentiality. Data will be securely stored and accessed only by authorized members of the research team for purposes approved by the ethics committee.

Publications

  • Lv L, Yang F, Li M, Xiao J, Yang H, Li D, Hu C, Wang Y, Xiao X, Jin L, Li Z, Zhou L, Wu Z, Wang H, Wu Y, Zhou H, Congdon N. Evaluating the effect of spectacle correction for refractive errors and presbyopia on cognitive function in rural older adults in China: protocol for a randomised, parallel-group, superiority trial. BMJ Open. 2026 Oct 7;16(10):e123629. doi: 10.1136/bmjopen-2026-123629.

    PubMed 42843862

Questions about this trial

What is this clinical trial studying?

A study testing Free Prescription Glasses in people with Cognition Disorders, run by Yuju Wu at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yuju Wu (86+18382096899, yujuwu@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in global cognitive function (time frame: Baseline to 12, 24, and 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06836440, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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