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Peer-reviewedCC BY-NC 4.0BMJ Open

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

  • Liang Lv1
  • Fan Yang1
  • Meng Li1
  • Jun Xiao2
  • Houjiang Yang1
  • Dongfeng Li3
  • Chunmei Hu4
  • Yiwen Wang4
  • Xiao Xiao3
  • Ling Jin5
  • Zhanrong Li6
  • Lin Zhou3
5 more authors
  • Zhengzheng Wu3
  • Huan Wang7
  • Yuju Wu1
  • Huan Zhou1
  • Nathan Congdon8,9,10
10 affiliations
  1. 1Department of Health Behavior and Social Medicine, West China School of Public Health and West China Fourth Hospital, Sichuan University, No. 16 South Renmin Road 3 Section, Chengdu 610041, Sichuan, China
  2. 2Sichuan Provincial Centre for Mental Health, Sichuan Provincial People’s Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, Sichuan, China
  3. 3Department of Ophthalmology, Sichuan Provincial People’s Hospital, University of Electronic Science and Technology of China, Chengdu, Sichuan, China
  4. 4Department of Otorhinolaryngology Head and Neck Surgery, Sichuan Provincial People’ s Hospital, University of Electronic Science and Technology of China, Chengdu, Sichuan, China
  5. 5State Key Laboratory of Ophthalmology, ZhongShan Ophthalmic Center Sun Yat-sen University, Guangzhou, China
  6. 6Henan Provincial People’s Hospital, People’s Hospital of Zhengzhou University, Zhengzhou, 450003, PR China
  7. 7616 Jane Stanford way, Encina Hall E503, Stanford University, Stanford, CA, 94305, California, USA
  8. 8Centre for Public Health, Queen's University Belfast (QUB), Belfast, UK
  9. 9Zhongshan Ophthalmic Centre, Sun Yat-Sen University, Guangzhou, China
  10. 10ORBIS, International, NY, New York, USA
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Abstract

Background: Vision impairment and mild cognitive impairment are highly prevalent in ageing rural populations of low- and middle-income countries. Observational studies suggest that vision correction may slow cognitive decline, but robust causal evidence—particularly from rural China—is lacking, despite an ongoing randomised controlled trial (RCT) in India. Our RCT will evaluate whether providing near and/or distance vision correction can slow cognitive decline among older adults in rural China, generating context-specific evidence to guide national policy and global healthy ageing strategies.

Methods: This study is designed as an assessor-blind, parallel-group, individually RCT. A total of 964 participants (482 per arm) aged 60–79 years with correctable refractive error-related visual impairment at distance and/or near (presenting visual acuity <6/12 in the better-seeing eye, improving to ≥6/7.5 in either eye with spectacle and/or near visual acuity <6/12 at 40 cm when measured binocularly, improving to ≥6/7.5 in either eye with spectacle), rural household registration, normal hearing (defined as a hearing threshold <40 dB in at least one ear, assessed using the HearX HearTest) and Mini-Mental State Examination, Second Edition, Simplified Chinese version scores above education-specific cut-offs will be enrolled. After comprehensive eye examinations at township health centres or village clinics, intervention participants will receive distance, near or bifocal spectacles while controls will receive a prescription and spectacles at trial closeout. The primary outcome is the change in global cognitive function from baseline to the 36-month follow-up, assessed using the Chinese version of the Montreal Cognitive Assessment Basic, with and without adjustment for baseline score, age, gender, education and other potential confounders.

Ethics and dissemination: The protocol is approved by the Institutional Review Board of West China School of Public Health and West China Fourth Hospital, Sichuan University, China (approval number: (HXSY-BEC-S2026005)). Results will be published in a peer-reviewed journal and presented at scientific meetings.

Trial registration number: NCT06836440 , 21 April 2025, ( https://clinicaltrials.gov/study/NCT06836440 ).

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Cite

BibTeXRIS
BibTeX
@article{lv2026evaluating,
  title = {{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}},
  author = {Liang Lv and Fan Yang and Meng Li and Jun Xiao and Houjiang Yang and Dongfeng Li and Chunmei Hu and Yiwen Wang and Xiao Xiao and Ling Jin and Zhanrong Li and Lin Zhou and Zhengzheng Wu and Huan Wang and Yuju Wu and Huan Zhou and Nathan Congdon},
  journal = {BMJ Open},
  year = {2026},
  month = oct,
  doi = {10.1136/bmjopen-2026-123629},
  url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-123629},
  note = {CC BY-NC 4.0},
}
RIS
TY  - JOUR
TI  - 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
AU  - Liang Lv
AU  - Fan Yang
AU  - Meng Li
AU  - Jun Xiao
AU  - Houjiang Yang
AU  - Dongfeng Li
AU  - Chunmei Hu
AU  - Yiwen Wang
AU  - Xiao Xiao
AU  - Ling Jin
AU  - Zhanrong Li
AU  - Lin Zhou
AU  - Zhengzheng Wu
AU  - Huan Wang
AU  - Yuju Wu
AU  - Huan Zhou
AU  - Nathan Congdon
PY  - 2026
DA  - 2026/10/07
JO  - BMJ Open
DO  - 10.1136/bmjopen-2026-123629
UR  - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-123629
AB  - Background: Vision impairment and mild cognitive impairment are highly prevalent in ageing rural populations of low- and middle-income countries. Observational studies suggest that vision correction may slow cognitive decline, but robust causal evidence—particularly from rural China—is lacking, despite an ongoing randomised controlled trial (RCT) in India. Our RCT will evaluate whether providing near and/or distance vision correction can slow cognitive decline among older adults in rural China, generating context-specific evidence to guide national policy and global healthy ageing strategies.  Methods: This study is designed as an assessor-blind, parallel-group, individually RCT. A total of 964 participants (482 per arm) aged 60–79 years with correctable refractive error-related visual impairment at distance and/or near (presenting visual acuity <6/12 in the better-seeing eye, improving to ≥6/7.5 in either eye with spectacle and/or near visual acuity <6/12 at 40 cm when measured binocularly, improving to ≥6/7.5 in either eye with spectacle), rural household registration, normal hearing (defined as a hearing threshold <40 dB in at least one ear, assessed using the HearX HearTest) and Mini-Mental State Examination, Second Edition, Simplified Chinese version scores above education-specific cut-offs will be enrolled. After comprehensive eye examinations at township health centres or village clinics, intervention participants will receive distance, near or bifocal spectacles while controls will receive a prescription and spectacles at trial closeout. The primary outcome is the change in global cognitive function from baseline to the 36-month follow-up, assessed using the Chinese version of the Montreal Cognitive Assessment Basic, with and without adjustment for baseline score, age, gender, education and other potential confounders.  Ethics and dissemination: The protocol is approved by the Institutional Review Board of West China School of Public Health and West China Fourth Hospital, Sichuan University, China (approval number: (HXSY-BEC-S2026005)). Results will be published in a peer-reviewed journal and presented at scientific meetings.  Trial registration number: NCT06836440 , 21 April 2025, ( https://clinicaltrials.gov/study/NCT06836440 ).
SN  - 2044-6055
SN  - 2044-6055
ER  -