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Downloaded from Validation of handheld fundus camera with mydriasis for retinal imaging to increase uptake of diabetic retinopathy screening in China ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2020-040196 Article Type: Original research Date Submitted by the 07-May-2020 Author: Complete List of Authors: Liao, Qinghua; Zhongshan Ophthalmic Centre, Sun Yat-sen University Xiao, Baixiang; Zhongshan Ophthalmic Centre, Sun Yat-sen University, The State Key Laboratory of Ophthalmology; Nanchang University Affiliated Eye Hospital, Li, Yanping; Nanchang University affiliated Eye Hospital Weng, Fan; Zhongshan Ophthalmic Centre, Sun Yat-sen University Jin, Ling; Sun Yat-Sen University Zhongshan Ophthalmic Center Wang, Yanfang; Zhongshan Ophthalmic Centre, Sun Yat-sen University Huang, Wenyong; Sun Yat-Sen University Zhongshan Ophthalmic Center Yi, Jinglin; Nanchang University Affiliated Eye Hospital Burton, Matthew J; London School of Hygiene and Tropical Medicine Yip, Jennifer; London School of Hygiene & Tropical Medicine http://bmjopen.bmj.com/ Diabetic retinopathy < DIABETES & ENDOCRINOLOGY, Diabetic Keywords: nephropathy & vascular disease < DIABETES & ENDOCRINOLOGY, OPHTHALMOLOGY on September 27, 2021 by guest. 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Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 23 1 2 3 BMJ Open: first published as 10.1136/bmjopen-2020-040196 on 29 October 2020. Downloaded from 4 Validation of handheld fundus camera with mydriasis for 5 6 7 retinal imaging to increase uptake of diabetic retinopathy 8 9 screening in China 10 11 12 1Qinghua Liao MS, 2, 3Baixiang Xiao MD, 3Yanping Li PhD, 4Fan Weng MS, 2Ling Jin MS, 13 2 2 3 6 6 14 Yanfang Wang MB, Wengyong Huang PhD, Jinglin Yi MD, Matthew Burton PhD, Jennifer 15 L Yip PhD 16 17 18 For peer review only 19 1. 20 Zhenjiang District Hospital, Shaoguan City, China 21 2. The State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-sen 22 University, Guangzhou, China. 23 3. Nanchang University Affiliated Eye Hospital, Nanchang City, China 24 25 4. Yuexiu District Centre of Disease Control, Guangzhou, China 26 5. International Centre for Eye Health, London School of Hygiene & Tropical Medicine, Keppel 27 Street, London WC1E 7HT, United Kingdom 28 29 30 Address for correspondence: Dr. Baixiang Xiao, The State Key Laboratory of Ophthalmology, 31 32 Zhongshan Ophthalmic Centre, Sun Yat-sen University, #54 South Xianlie Road, Guangzhou 33 City, Guangdong Province, China 510060 Tel/Fax: +86 20 8733 4645, Email: 34 35 [email protected] 36 37 Word count: 3993 http://bmjopen.bmj.com/ 38 39 Running head: Validation of handheld fundus camera 40 41 42 Keywords: validation, fundus camera, sensitivity, specificity, diabetic retinopathy, 43 44 45 on September 27, 2021 by guest. Protected copyright. 46 The conflicts of interest: The authors declare that they have no conflicts of interest. 47 48 49 Funding: The study is fully funded by the State Key Laboratory of Ophthalmology, Zhongshan 50 Ophthalmic Centre, Sun Yat-sen University 51 52 Data sharing: Full data is available on the request from the corresponding author. 53 54 55 56 57 58 59 60 1 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 23 BMJ Open 1 2 3 BMJ Open: first published as 10.1136/bmjopen-2020-040196 on 29 October 2020. Downloaded from Contributorship statement: 4 5 6 Q Liao: preliminary draft of the tables and manuscript, data analysis and critical revision of the 7 manuscript. 8 9 10 B Xiao: study design, training of the study teams, monitoring data collection and quality 11 control, data cleaning, analysis as well as manuscript drafting and revision. 12 13 Y Li: Monitoring of grading and valuable contribution to the revision of the manuscript. 14 15 16 F Weng: data collection and valuable contribution to the study design. 17 18 L Jin: statistical analysisFor and peer helpful revision review of the manuscript. only 19 20 Y Wang: data cleaning and valuable contribution to the manuscript drafting. 21 22 23 J Yi, W Huang: valuable contribution to the study design and revision of the manuscript. 24 25 J Yip, M Burton: Substantial contributions to the conception, designing, and revision of the 26 manuscript as well as analysis and interpretation of the data. 27 28 29 30 31 32 33 34 35 36 37 http://bmjopen.bmj.com/ 38 39 40 41 42 43 44 45 on September 27, 2021 by guest. Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 2 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 23 1 2 3 Abstract: BMJ Open: first published as 10.1136/bmjopen-2020-040196 on 29 October 2020. Downloaded from 4 5 6 Objectives: To investigate the clinical validity of using a handheld fundus camera to detect 7 diabetic retinopathy (DR) in China. 8 9 10 Design and settings: Prospective comparison of the handheld fundus camera with the 11 standard validated instrument in detection of DR in hospital and a community screening clinic 12 13 in Guangdong Province, China. 14 15 Participants: Participants aged 18 and over with diabetes who were able to provide informed 16 17 consent and agreed to attend the dilated eye examination with handheld tests and gold 18 standard tests. For peer review only 19 20 21 Primary and secondary outcome measures: Primary outcome was the proportion of those 22 with referable DR (R2 and above) identified by the handheld fundus camera (the index test) 23 compared with the standard camera. Secondary outcome was the comparison of proportion of 24 25 gradable images obtained from each test. 26 27 Results: 28 29 30 In this study, we examined 304 people (608 eyes) with each of the two cameras under 31 mydriasis.