Evidence map›Paper›PMID 36057664›Full record

ArticleEye (London, England)2023

A multi-centre prospective evaluation of THEIA™ to detect diabetic retinopathy (DR) and diabetic macular oedema (DMO) in the New Zealand screening program.

Ehsan Vaghefi, Song Yang, Li Xie, David Han, Aaron Yap, Ole Schmeidel, John Marshall, David Squirrell

Abstract readMulticenter Study
In one paragraph

Article in Eye (London, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Current Trends in AI and Eye Disease Diagnostics.Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists) · 2026
    Review
  3. Article
  4. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Ehsan VaghefiToku Eyes®, Auckland, New Zealand. e.vaghefi@tokueyes.com.ORCID 0000-0002-9482-3168
Song YangToku Eyes®, Auckland, New Zealand.
Li XieToku Eyes®, Auckland, New Zealand.
David HanToku Eyes®, Auckland, New Zealand.
Aaron YapDepartment of Ophthalmology, The University of Auckland, Auckland, New Zealand.
Ole SchmeidelDepartment of Diabetes, Auckland District Health Board, Auckland, New Zealand.
John MarshallInstitute of Ophthalmology, University College of London, London, UK.ORCID 0000-0001-6372-9294
David SquirrellToku Eyes®, Auckland, New Zealand.

Funding

Ministry of Business, Innovation and Employment (MBIE) UOAX1805 - 3715780
6 · The paper itself

Abstract

purposeTo validate the potential application of THEIA™ as clinical decision making assistant in a national screening program.

methodsA total of 900 patients were recruited from either an urban large eye hospital, or a semi-rural optometrist led screening provider, as they were attending their appointment as part of New Zealand Diabetic Eye Screening Programme. The de-identified images were independently graded by three senior specialists, and final results were aggregated using New Zealand grading scheme, which was then converted to referable/non-referable and Healthy/mild/more than mild/sight threatening categories.

resultsTHEIA™ managed to grade all images obtained during the study. Comparing the adjudicated images from the specialist grading team, "ground truth", with the grading by the AI platform in detecting "sight threatening" disease, at the patient level THEIA™ achieved 100% imageability, 100% [98.49-100.00%] sensitivity and [97.02-99.16%] specificity, and negative predictive value of 100%. In other words, THEIA™ did not miss any patients with "more than mild" or "sight threatening" disease. The level of agreement between the clinicians and the aggregated results was (k value: 0.9881, 0.9557, and 0.9175), and the level of agreement between THEIA™ and the aggregated labels was (k value: 0.9515).

conclusionThis multi-centre prospective trial showed that THEIA™ did not miss referable disease when screening for diabetic retinopathy and maculopathy. It also had a very high level of granularity in reporting the disease level. As THEIA™ has been tested on a variety of cameras, operating in a range of clinics (rural/urban, ophthalmologist-led\optometrist-led), we believe that it will be a suitable addition to a public diabetic screening program.

Indexed as

Diabetes MellitusDiabetic RetinopathyMacular EdemaHumansMass ScreeningNew ZealandPredictive Value of Tests

Identifiers

PMID36057664
PMCPMC10219993

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.