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Validation of Smartphone Based Retinal Photography for Diabetic Retinopathy Screening
Open accessAbstract
AIM: To evaluate the sensitivity and specificity of "fundus on phone' (FOP) camera, a smartphone based retinal imaging system, as a screening tool for diabetic retinopathy (DR) detection and DR severity in comparison with 7-standard field digital retinal photography. DESIGN: Single-site, prospective, comparative, instrument validation study. METHODS: 301 patients (602 eyes) with type 2 diabetes underwent standard seven-field digital fundus photography with both Carl Zeiss fundus camera and indigenous FOP at a tertiary care diabetes centre in South India. Grading of DR was performed by two independent retina specialists using modified Early Treatment of Diabetic Retinopathy Study grading system. Sight threatening DR (STDR) was defined by the presence of proliferative DR(PDR) or diabetic macular edema. The sensitivity, specificity and image quality were assessed. RESULTS: The mean age of the participants was 53.5 ±9.6 years and mean duration of diabetes 12.5±7.3 years. The Zeiss camera showed that 43.9% had non-proliferative DR(NPDR) and 15.3% had PDR while the FOP camera showed that 40.2% had NPDR and 15.3% had PDR. The sensitivity and specificity for detecting any DR by FOP was 92.7% (95%CI 87.8-96.1) and 98.4% (95%CI 94.3-99.8) respectively and the kappa (ĸ) agreement was 0.90 (95%CI-0.85-0.95 p<0.001) while for STDR, the sensitivity was 87.9% (95%CI 83.2-92.9), specificity 94.9% (95%CI 89.7-98.2) and ĸ agreement was 0.80 (95%CI 0.71-0.89 p<0.001), compared to conventional photography. CONCLUSION: Retinal photography using FOP camera is effective for screening and diagnosis of DR and STDR with high sensitivity and specificity and has substantial agreement with conventional retinal photography.
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“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 [16]
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“Image acquisition was often performed by trained non-physician staff (technicians, optometrists, nurses, paramedics), while final grading was typically carried out by ophthalmologists or retinal specialists (22/30 studies) [8–13, 15, 16, 18, 21, 22, 24, 26, 27, 30–37]”
From Diabetic retinopathy screening model in low and middle-income countries: a scoping review (2025) · cites this paper as [16]
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“Studies using AI software, such as the Iowa Diabetic Retinopathy detection software [15] and EyeArt [21] show high sensitivity up to 95,8% (95% CI 92,9–98,7) and diagnostic accuracy [16].”
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“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 [16]
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“A study conducted in India using the “Fundus on Phone” system also demonstrated lower costs compared to conventional fundus cameras [16].”
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Metadata
- Authors
- Rajalakshmi, R., Arulmalar, S., Usha, M., Prathiba, V., Kareemuddin, K. S., Anjana, R. M., & Mohan, V.
- Affiliations
- Madras Diabetes Research Foundation (IN)
- Corresponding author
- Mohan, Viswanathan
- Venue
- PLOS ONE
- Publisher
- Public Library of Science (PLoS)
- Published
- 2015-09-24
- Volume
- 10
- Issue
- 9
- Pages
- e0138285
- ISSN
- 1932-6203 (ISSN-L)
- PMC
- PMC4581835
- OpenAlex
- W2179023931
- Cited by
- 173
- References
- 30
- Citations by year
- 2026: 10 · 2025: 12 · 2024: 15 · 2023: 13 · 2022: 19 · 2021: 23 · 2020: 39 · 2019: 18 · 2018: 16 · 2017: 4 · 2016: 4
- FWCI
- 6.48
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- PLoS ONE (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Retinal Imaging and Analysis
- Health Sciences › Medicine › Ophthalmology › Ophthalmology and Visual Health Research
- Health Sciences › Medicine › Ophthalmology › Retinal Diseases and Treatments
- Keywords
- diabetic retinopathy, diabetic retinopathy screening, type 2 diabetes, diabetic macular edema, proliferative diabetic retinopathy, diagnostic accuracy, image quality, low-cost screening
- MeSH terms
- Smartphone, Adult, Aged, Diabetic Retinopathy, Female, Humans, Male, Mass Screening, Middle Aged, Photography, Sensitivity and Specificity, Severity of Illness Index, Ophthalmoscopes, Young Adult
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