Validation of handheld fundus camera with mydriasis for retinal imaging of diabetic retinopathy screening in China: a prospective comparison study

Objectives To investigate the clinical validity of using a handheld fundus camera to detect diabetic retinopathy (DR) in China. Design and settings Prospective comparison study of the handheld fundus camera with a standard validated instrument in detection of DR in hospital and a community screening clinic in Guangdong Province, China. Participants Participants aged 18 years and over with diabetes who were able to provide informed consent and agreed to attend the dilated eye examination with handheld tests and a standard desktop camera. Primary and secondary outcome measures Primary outcome was the proportion of those with referable DR (R2 and above) identified by the handheld fundus camera (the index test) compared with the standard camera. Secondary outcome was the comparison of proportion of gradable images obtained from each test. Results In this study, we examined 304 people (608 eyes) with each of the two cameras under mydriasis. The handheld camera detected 119 eyes (19.5%) with some level of DR, 81 (13.3%) of them were referable, while the standard camera detected 132 eyes (21.7%) with some level of DR and 83 (13.7%) were referable. It seems that the standard camera found more eyes with referable DR, although McNemar’s test detected no significant difference between the two cameras. Of the 608 eyes with images obtained by desktop camera, 598 (98.4%) images were of sufficient quality for grading, 12 (1.9%) images were not gradable. By the handheld camera, 590 (97.0%) were gradable and 20 (3.2%) images were not gradable. The two cameras reached high agreement on diagnosis of retinopathy and maculopathy at all the levels of retinopathy. Conclusion Although it could not take the place of standard desktop camera on clinic fundus examination, the handheld fundus camera showed promising role on preliminary DR screening at primary level in China. To ensure quality images, mydriasis is required.

[1]  Q. Meng,et al.  Prevalence and risk factors for diabetic retinopathy in a cross-sectional population-based study from rural southern China: Dongguan Eye Study , 2019, BMJ Open.

[2]  J. Yip,et al.  Diagnostic test accuracy of diabetic retinopathy screening by physician graders using a hand-held non-mydriatic retinal camera at a tertiary level medical clinic , 2019, BMC Ophthalmology.

[3]  Hans Limburg,et al.  Prevalence and causes of blindness and vision impairment: magnitude, temporal trends and projections in South and Central Asia , 2018, British Journal of Ophthalmology.

[4]  P. Scanlon,et al.  Factors determining uptake of diabetic retinopathy screening in Oxfordshire , 2017, Diabetic medicine : a journal of the British Diabetic Association.

[5]  Shan Wang,et al.  Prevalence, Awareness, and Risk Factors of Diabetic Retinopathy among Adults with Known Type 2 Diabetes Mellitus in an Urban Community in China , 2017, Ophthalmic epidemiology.

[6]  Yan Liu,et al.  Prevalence of diabetic retinopathy among 13473 patients with diabetes mellitus in China: a cross-sectional epidemiological survey in six provinces , 2017, BMJ Open.

[7]  Gerald Liew,et al.  A comparison of the causes of blindness certifications in England and Wales in working age adults (16–64 years), 1999–2000 with 2009–2010 , 2014, BMJ Open.

[8]  N. Morlet,et al.  Improving the uptake of screening for diabetic retinopathy , 2013, The Medical journal of Australia.

[9]  Virasakdi Chongsuvivatwong,et al.  Strategies of Digital Fundus Photography for Screening Diabetic Retinopathy in a Diabetic Population in Urban China , 2012, Ophthalmic epidemiology.

[10]  Z. Shan,et al.  Prevalence of Diabetic Retinopathy in Mainland China: A Meta-Analysis , 2012, PloS one.

[11]  Xixi Yan,et al.  Attitudes of physicians, patients, and village health workers toward glaucoma and diabetic retinopathy in rural China: a focus group study. , 2012, Archives of ophthalmology.

[12]  Mingguang He,et al.  Use of eye care services among diabetic patients in urban and rural China. , 2010, Ophthalmology (Rochester, Minn.).

[13]  K. Dou,et al.  Prevalence of diabetes among men and women in China. , 2010, The New England journal of medicine.

[14]  D. Friedman,et al.  Prevalence of diabetic retinopathy in rural China: the Handan Eye Study. , 2009, Ophthalmology.

[15]  P. Boyle,et al.  Screening Uptake in a Well-Established Diabetic Retinopathy Screening Program , 2008, Diabetes Care.

[16]  Apichat Suansilpong,et al.  Accuracy of single-field nonmydriatic digital fundus image in screening for diabetic retinopathy. , 2008, Journal of the Medical Association of Thailand = Chotmaihet thangphaet.

[17]  P. Scanlon,et al.  Comparison of two reference standards in validating two field mydriatic digital photography as a method of screening for diabetic retinopathy , 2003, The British journal of ophthalmology.

[18]  P. Scanlon,et al.  The effectiveness of screening for diabetic retinopathy by digital imaging photography and technician ophthalmoscopy , 2003, Diabetic medicine : a journal of the British Diabetic Association.

[19]  B. Jönsson,et al.  The economic impact of diabetes. , 1998, Diabetes care.

[20]  L T Chylack,et al.  Evaluation of lens opacities classification system III applied at the slitlamp. , 1993, Optometry and vision science : official publication of the American Academy of Optometry.

[21]  Ping Zhang,et al.  Economic impact of Diabetes , 2010 .