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

Official title

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

Overview

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.

Interventions

• Device Free Prescription Glasses
  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

Primary outcome measures

• **Chinese version of the Global Cognitive Score Scale** [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.]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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);

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

China · 1 center

• Community health service centers — Ya'an

Identifiers

NCT: NCT06836440 · HXSY-BEC-S2026005

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗