Impact of Glasses for Vision Problems on Cognitive Function in Rural Older Adults
ConditionCognition Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-79
SponsorYuju Wu
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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);
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Free Prescription Glasses
DeviceParticipants 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.
Treatment groups
964 Participants
are divided into 2 treatment groupsGroup A: Free Prescription Glasses Intervention groupExperimental treatment 1 intervention
Group B: Prescription-Only Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
**Chinese version of the Global Cognitive Score Scale**
The primary endpoint is the change in cognitive function over three years, which is comprehensively determined using the Chinese version of the Global Cognitive Score Scale-by administering the Chinese version Mini-Mental State Examination (C-MMSE), Beijing version of the Montreal Cognitive Assessment (MoCA), Telephone Interview for Cognitive Status (TICS), Community Screening Instrument for Dementia Interviewee Part (CSI-D), and Number Series Test.
Time frame
Each participant will undergo cognitive assessments at baseline, 12 months, 24 months, and 36 months to evaluate the impact of the intervention on cognitive decline.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yuju Wu
Lead sponsor
Sichuan University
Sponsor institution
Source ClinicalTrials.gov