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Cited by 70Retinal Imaging and AnalysisRetinal Diseases and TreatmentsOphthalmology and Visual Health Research

Diagnostic test accuracy of diabetic retinopathy screening by physician graders using a hand-held non-mydriatic retinal camera at a tertiary level medical clinic

Open access
Piyasena, Mapa Mudiyanselage Prabhath Nishant, Yip, Jennifer L. Y., MacLeod, David, Kim, Min, Gudlavalleti, Venkata S. Murthy·2019·BMC Ophthalmology
DOI 10.1186/s12886-019-1092-3PMC PMC6454614

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Abstract

BACKGROUND: The evidence on diagnostic test accuracy (DTA) of diabetic retinopathy (DR) screening utilising photographic studies by non-ophthalmologist personnel in low and middle-income country (LMIC) settings is scarce. We aimed to assess DTA of DR screening using a nonmydriatic hand-held digital camera by trained general physicians in a non-ophthalmic setting. METHODS: This study is a validation of a screening intervention. We selected 700 people with diabetes (PwDM) > 18 years of age, not previously screened or treated for DR, presenting at a tertiary medical clinic in Sri Lanka. Two-field retinal imaging was used to capture fundus images before and after pupil dilatation, using a hand-held non-mydriatic (Visuscout 100®-Germany) digital retinal camera. The images were captured and graded by two trained, masked independent physician graders. The DTA of different levels of DR was assessed comparing physician's grading with a retinologist's clinical examination by mydriatic bio-microscopy, according to a locally adopted guideline. RESULTS: Seven hundred eligible PwDM were screened by physician graders. The mean age of participants was 60.8 years (SD ±10.08) and mean duration of DM was 9.9 years (SD ±8.09). Ungradable image proportion in non-mydriatic imaging was 43.4% (either eye-31.3%, both eyes 12.1%). This decreased to 12.8% (either eye-11.6%, both eyes-1.2%) following pupil dilatation. In comparison to detection of any level of DR, a referable level DR (moderate non-proliferative DR and levels above) showed a higher level of DTA. The sensitivity of the defined referable DR was 88.7% (95% CI 81.7-93.8%) for grader 1 (positive predictive value [PPV] 59.1%) and 92.5% (95% CI 86.4-96.5%) for grader 2 (PPV 68%), using mydriatic imaging, after including ungradable images as screen positives. The specificity was 94.9% (95% CI 93.6-96.0%) for grader 1 (negative predictive value [NPV] 99%) and 96.4% (95% CI 95.3-97.3%) for grader 2 (NPV 99.4%). CONCLUSIONS: The Physicians grading of images from a digital hand-held non-mydriatic camera at a medical clinic, with dilatation of pupil of those who have ungradable images, provides a valid modality to identify referable level of DR. This could be a feasible alternative modality to the existing opportunistic screening to improve the access and coverage. TRIAL REGISTRATION: Current Controlled Trials ISRCTN47559703 . Date of Registration 18th March 2019, Retrospectively registered.

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  • Remote grading of retinal images was widely utilized, with 18 out of 30 studies relying on this approach.

    “Remote grading of retinal images is widely utilized, with 18 out of 30 studies relying on this approach [10, 15, 16, 18, 21–27, 29–35, 37]”

    From Diabetic retinopathy screening model in low and middle-income countries: a scoping review (2025) · cites this paper as [26]

    The Methods (page not provided) describe physicians grading retinal images at a tertiary-level medical clinic. They do not establish that the grading was remote, and this single-study paper does not report the cited count of 18 out of 30 studies. (LLM, conf=0.82)

    Experimental — accuracy not yet measured

  • The predominant method for managing remotely graded images was store and forward (14 out of 30 studies), with seven studies adopting real-time processing.

    “The predominant method for managing these remotely graded images is ‘store and forward’ (14 out of 30 studies) [15, 16, 18, 22–24, 26–30, 33, 35, 37], with seven studies adopting the ‘real-time’ processing method [8, 10, 11, 25, 31, 32, 34]”

    From Diabetic retinopathy screening model in low and middle-income countries: a scoping review (2025) · cites this paper as [26]

    The Methods describe physicians capturing and grading retinal images at a medical clinic, while the Discussion mentions digital image storage and retrieval. Neither section reports a tally of 30 studies or identifies this study as using remote store-and-forward or real-time grading (searched: “store-and-forward,” “real-time,” and remote grading). (LLM, conf=0.76)

    Experimental — accuracy not yet measured

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Research works printed but not linked: 1

  1. [2]IDF. International Diabetes Federation Diabetes Atlas - Eighth Edition - 2017. http://www.diabetesatlas.org/resources/2017-atlas.html. Accessed 10 June 2018.

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Authors
Piyasena, M. M. P. N., Yip, J. L. Y., MacLeod, D., Kim, M., & Gudlavalleti, V. S. M.
Affiliations
London School of Hygiene & Tropical Medicine (GB)
ORCID
Venue
BMC Ophthalmology
Publisher
Springer Science and Business Media LLC
Published
2019-04-08
Volume
19
Issue
1
Pages
89-89
ISSN
1471-2415 (ISSN-L)
DOI
10.1186/s12886-019-1092-3
PMC
PMC6454614
OpenAlex
W2945282322
Cited by
70
References
55
Citations by year
2026: 6 · 2025: 14 · 2024: 10 · 2023: 13 · 2022: 9 · 2021: 12 · 2020: 5 · 2019: 1
FWCI
4.46
Type
journal article
Language
en
Open access
Licence
Locations
  • BMC Ophthalmology (publishedVersion, cc-by)
  • Research Square (acceptedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
Queen Elizabeth Diamond Jubilee Trust, coordinated through the Commonwealth Eye Health Consortium - United Kingdom. (ITRCRZC6812)
Topics
  • Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Retinal Imaging and Analysis
  • Health Sciences › Medicine › Ophthalmology › Retinal Diseases and Treatments
  • Health Sciences › Medicine › Ophthalmology › Ophthalmology and Visual Health Research
Keywords
diabetic retinopathy, diabetic retinopathy screening, pupil dilation, diagnostic accuracy, sensitivity and specificity, referable diabetic retinopathy, diabetes mellitus, low- and middle-income countries, Sri Lanka, fundus photography
MeSH terms
Diabetic Retinopathy, Equipment Design, Female, Humans, Image Processing, Computer-Assisted, Male, Middle Aged, Mydriatics, Photography, Physicians, Prospective Studies, Retina, Reproducibility of Results, Vision Screening, Tertiary Care Centers

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