An interventional study of Free Prescription Glasses in Cognition Disorders, sponsored by Yuju Wu. Recruiting at 1 site in China. Open to participants aged 60 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Yuju Wu · Not applicable, Interventional, and Prevention
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.
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.
399 studies on the registry are indexed under Cognition Disorders; 74 are open to participants now.
This study's planned enrollment of 964 is above the median of 66 across 272 interventional studies indexed under Cognition Disorders.
Browse Cognition Disorders studies →Yuju Wu is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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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.
Older adults who meet all of the following criteria will be eligible to participate in this study:
Exclusion Criteria:
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.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All 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.
Device: Free Prescription Glasses
All 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.
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.
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.
Time frame: Baseline to 12, 24, and 36 months
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.
Time frame: Baseline to 12, 24, and 36 months
Change in falls risk
Falls risk will be assessed using the prespecified falls-risk assessment included in the study protocol.
Time frame: Baseline to 12, 24, and 36 months
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).
Time frame: Baseline to 12, 24, and 36 months
Change in health-related quality of life
Health-related quality of life will be assessed using the EQ-5D-5L.
Time frame: Baseline to 12, 24, and 36 months
Change in depressive symptoms
Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire (PHQ-9).
Time frame: Baseline to 12, 24, and 36 months
Change in physical activity
Physical activity will be assessed using the short form of the International Physical Activity Questionnaire (IPAQ-SF)
Time frame: Baseline to 12, 24, and 36 months
Change in social network
Social network will be assessed using the Lubben Social Network Scale-6 (LSNS-6)
Time frame: Baseline to 12, 24, and 36 months
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.
Time frame: From baseline through 36 months
Plan to share: 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.
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