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Record W4408969565 · doi:10.1186/s13063-025-08813-x

Cognitive Level Enhancement through Vision Exams and Refraction (CLEVER): study protocol for a randomised controlled trial

2025· article· en· W4408969565 on OpenAlexfundno aff
Srinivas Marmamula, Suvarna Alladi, Keerthana Umapathy, Ving Fai Chan, Graeme MacKenzie, Lynne Lohfeld, Asha Latha Mettla, Sridevi Rayasam, Vijaya K. Gothwal, Raja Narayanan, Pyda Giridhar, Harithaa P. Chadalavada, Priya Thomas, Lovemore Nyasha Sigwadhi, Augusto Azuara‐Blanco, Clíona McDowell, Susan McMullan, Lynn Murphy, Mike Clarke, Joshua R. Ehrlich, Bonnielin Sweenor, Ciarán O’Neill, Shashidhar Komaravolu, Pallab K Maulik, G. V. S. Murthy, Keshav Kumar, Anant Nyshadham, Achyuta Adhvaryu, Christopher McCabe, David E. Bloom, Jinkook Lee, Frank R. Lin, S.F.E. COGHLAN, Rohit Khanna, Nathan Congdon

Bibliographic record

VenueTrials · 2025
Typearticle
Languageen
FieldMedicine
TopicOphthalmology and Visual Impairment Studies
Canadian institutionsnot available
FundersQueen's University BelfastQueen's UniversityWellcome Trust
KeywordsMedicineRandomized controlled trialCognitionObservational studyDementiaVisual acuityProtocol (science)Cognitive declineConfoundingPhysical therapyOptometryOphthalmologyPsychiatryInternal medicineAlternative medicine

Abstract

fetched live from OpenAlex

BACKGROUND: Longitudinal observational studies have found an association between vision impairment and accelerated decline in cognition. However, no randomised trials have assessed the possible benefit of vision correction on cognitive change. We present the protocol for a three-year randomised controlled trial designed to assess the impact of spectacles for distance and/or near vision correction on cognitive change among community-dwelling elderly participants in India. METHODS: Cognitive Level Enhancement through Vision Exams and Refraction (CLEVER) is a single-centre, open-label, parallel-group, individually-randomised trial. Participants (760 total, 380 in each arm) aged ≥ 60 years with correctable vision impairment at distance and/or near (presenting visual acuity < 6/18 in the better-seeing eye and improving to > = 6/18 with spectacles and/or presenting near vision worse than N6 at 40 cm and improving to N6 with spectacles), normal hearing (able to repeat at least three out of six words whispered from a 50 cm distance in the better ear) and normal cognition (Hindi Mini-mental Status Examination score > 18/31) will be enrolled. After a comprehensive eye examination, intervention group participants will receive distance, near, or bifocal spectacles, while controls will receive a prescription and spectacles at the end of the trial. The primary outcome will be the three-year change in Longitudinal Aging Study in India-Diagnostic Assessment of Dementia (LASI DAD) global cognitive factor score, with and without adjustment for baseline score, age, gender, education and other potential confounders. CONCLUSION: CLEVER is designed to assess the effectiveness of spectacles as a low-cost intervention to prevent or delay cognitive decline. TRIAL REGISTRATION: This trial is registered with ClinicalTrials.gov, number NCT05458323, February 15, 2023.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.004
metaresearch head score (Gemma)0.006
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Protocol · Consensus signal: Protocol
Teacher disagreement score0.083
Threshold uncertainty score0.748

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0040.006
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0020.000
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.319
GPT teacher head0.573
Teacher spread0.253 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designRandomized trial
Domainnot available
GenreProtocol

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations2
Published2025
Admission routes1
Has abstractyes

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