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Record W4417405604 · doi:10.1038/s41433-025-04112-6

Development and standardisation of ‘time-in-range’ measurement for clinical endpoints in retinal diseases

2025· review· en· W4417405604 on OpenAlexaff
Luisa Frizziero, Jane Barratt, Chui Ming Gemmy Cheung, A. Korol, Edoardo Midena, James Talks, Miltiadis K. Tsilimbaris, Ian Pearce, Igor Kozak

Bibliographic record

VenueEye · 2025
Typereview
Languageen
FieldMedicine
TopicOphthalmology and Visual Impairment Studies
Canadian institutionsInternational Federation on Ageing
FundersFondazione RomaUniversità degli Studi di Padova
KeywordsClinical endpointVisual acuityEndpoint DeterminationDiseaseRetinalClinical trialSurrogate endpointMEDLINE

Abstract

fetched live from OpenAlex

Clear and updated endpoints are required to measure outcomes of a disease course and/or a therapeutic intervention. The aim of this review is to identify a reliable 'time-in-range' endpoint of clinical outcomes in ocular conditions, with a particular focus on exudative diseases involving the posterior pole of the eye, and to explore possible applications of this endpoint. A PubMed search was carried out pertaining to: 'time-in-range', 'clinical-outcome', 'clinical-endpoint', 'clinical trial', 'metrics', 'retina', 'retinopathy', 'macular-oedema', 'maculopathy', 'ophthalmology', 'visual-function', 'visual acuity end-point' and 'OCT'. The results showed that both functional and morphological endpoints have been used in the evaluation of retinal diseases. At present, the most widely accepted and clinically meaningful marker of ocular disease is 'mean change' in best corrected visual acuity (BCVA). While comparisons to baseline at various timepoints are commonly recommended to evaluate statistical and clinically relevant differences, few metrics capture the disease course continuously over time. In other medical fields, 'time-in-range' has been introduced to provide more complete information on the fluctuations characterising the course of a disease. The application of 'time-in-range' on BCVA in exudative diseases involving the posterior pole seems feasible, reliable and applicable in clinical practice. BCVA 'time-in-range' offers a useful and practical endpoint in retinal diseases, evaluating both visual function at the end of an observation/treatment and fluctuations in disease over time. It may also be applied to other clinical and morphological endpoints in ocular diseases, including macular thickness. This review presents a hypothesis-generating framework proposing 'time-in-range' as a supplementary metric, pending prospective validation.

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)0.001
metaresearch head score (Gemma)0.001
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Other design · Consensus signal: none
GenreCandidate signal: Review · Consensus signal: Review
Teacher disagreement score0.804
Threshold uncertainty score0.526

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0010.001
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
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 head0.201
GPT teacher head0.508
Teacher spread0.306 · 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 designOther design
Domainnot available
GenreReview

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

Citations0
Published2025
Admission routes1
Has abstractyes

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