Compared non-mydriatic two-field 45° fundus imaging methods with non-mydriatic two ultra-widefield fundus imaging in a large-scale diabetic retinopathy screening_Chinese Journal of Ocular Fundus Diseases

Authors：

Xiao Yuanyuan ¹ , Dan Handong ¹ , Xiao Tianlei ² , Xu Jingxuan ¹ , Wang Wanxiao ¹ , Wang Yange ¹ ,  Song Zongming ¹

1. Zhengzhou University People's Eye Hospital, Henan Eye Hospital, Henan Eye Institution, Henan Provincial People's Hospital, Henan Key Laboratory of Ophthalmology and Visual Science, Henan Key Laboratory of Ophthalmology, Zhengzhou 450003, China;
2. Anyang Institute of Technology School of Computer Science and Information Engineering, Anyang 455000, China;

Corresponding?author：

Song Zongming, Email: szmeyes@126.com

Keywords：

Diabetic retinopathy; Diagnostic imaging; Ultra-widefield fundus imaging

DOI：

10.3760/cma.j.cn511434-20211011-00572

Video：

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Objective To compare the consistency and difference of non-mydriatic two-field 45° ultra-wide field Optos and Clarus500 fundus imaging in a large-scale diabetic retinopathy (DR) screening. Methods A diagnostic methodology study. From November 2020 to August 2021, 526 eyes of 277 patients with type 2 diabetes who diagnosed in Department of Ophthalmology, Henan Provincial People's Hospital were included in the study. Among them, there were 175 males with 328 eyes and 102 females with 198 eyes; the age was 53±10 years old. The same experienced technician performed the non-mydriatic dual-field 45° fundus imaging and the non-mydriatic ultra-wide-angle imaging system Optos, Clarus500 single-field fundus imaging examination on the patient on the same day, and obtained the dual-field 45° fundus image and Optos, Clarus500 single-field fundus image. The Optos and Clarus500 single-field fundus images in the same area as the dual-field 45° fundus image were captured by Photoshop software, and the Optos and Clarus500 dual-field fundus images were obtained. Subsequently, two experienced ophthalmologists performed interpretation and DR grading of the 5 groups of images, respectively. Images with inconsistent grading results were interpreted by a third ophthalmologist and used as the final grading result. In order to avoid the mydriatic dual-field 45° imaging interpretation results as the standard, the consistency and detection rate difference of the two ultra-wide-angle imaging systems in the rapid DR screening results were evaluated. The weighted Kappa (κ) test was used to analyze the consistency of DR diagnosis between dual-field 45° fundus imaging and Optos and Clarus500 fundus imaging; χ² test was used to compare the detection rates of DR between different imaging systems. Results Compared with the dual-field 45° fundus image, the Clarus500 single-field had a higher DR detection rate (χ²=24.965, P＜0.001), and the Optos dual-field fundus image had a lower DR detection rate (χ²=49.559, P＜0.001). Compared with the DR detection rate of dual-field 45° fundus image, Optos single-field fundus image, Clarus500 double-field fundus image had no significant difference (χ²=2.572, 0.649; P=0.109, 0.421). Compared with Optos, Clarus500 single-field and dual-field fundus images DR detection rate, the difference was statistically significant (χ²=43.214, 61.216; P＜0.001). Consistency assessment of DR grading results: dual-field 45° fundus images and Clarus500 dual-field fundus images (κ value=0.932, 95% confidence interval (CI) 0.907-0.956) were highly consistent; dual-field 45° fundus images and Optos single-field fundus images [κ value=0.474, 95%CI 0.417-0.532], Optos dual-field fundus image (κ value=0.495, 95%CI 0.438-0.551), Optos dual-field fundus image (κ value=0.495, 95%CI 0.438-0.551) and Clarus500 dual-field fundus image (κ value=0.452, 95%CI 0.395-0.506) were moderately consistent; dual-field 45°fundus images and Clarus500 single-field fundus images (κ value=0.354, 95%CI 0.303-0.403) and Optos single-field fundus images and Clarus500 single-field fundus images (κ value=0.347, 95%CI 0.287-0.393) showed general agreement. Conclusions Compared with Optos dual-field fundus image, dual-field 45°fundus image and Clarus500 dual-field fundus image have high consistency in the grading results of DR rapid screening. Compared with Optos single-field fundus image, the detection rate of the DR of Clarus500 single-field fundus image is higher.

Citation： Xiao Yuanyuan, Dan Handong, Xiao Tianlei, Xu Jingxuan, Wang Wanxiao, Wang Yange, Song Zongming. Compared non-mydriatic two-field 45° fundus imaging methods with non-mydriatic two ultra-widefield fundus imaging in a large-scale diabetic retinopathy screening. Chinese Journal of Ocular Fundus Diseases, 2022, 38(8): 681-687. doi: 10.3760/cma.j.cn511434-20211011-00572 Copy

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2.	Mohamed Q, Gillies MC, Wong TY. Management of diabetic retinopathy: a systematic review[J]. JAMA, 2007, 298(8): 902-916. DOI: 10.1001/jama.298.8.902.
3.	Wang LZ, Cheung CY, Tapp RJ, et al. Availability and variability in guidelines on diabetic retinopathy screening in Asian countries[J]. Br J Ophthalmol, 2017, 101(10): 1352-1360. DOI: 10.1136/bjophthalmol-2016-310002.
4.	Nguyen HV, Tan GS, Tapp RJ, et al. Cost-effectiveness of a national telemedicine diabetic retinopathy screening program in Singapore[J]. Ophthalmology, 2016, 123(12): 2571-2580. DOI: 10.1016/j.ophtha.2016.08.021.
5.	Scanlon PH. The English National Screening Programme for diabetic retinopathy 2003-2016[J]. Acta Diabetol, 2017, 54(6): 515-525. DOI: 10.1007/s00592-017-0974-1.
6.	Thomas RL, Dunstan FD, Luzio SD, et al. Prevalence of diabetic retinopathy within a national diabetic retinopathy screening service[J]. Br J Ophthalmol, 2015, 99(1): 64-68. DOI: 10.1136/bjophthalmol-2013-304017.
7.	Aldington SJ, Kohner EM, Meuer S, et al. Methodology for retinal photography and assessment of diabetic retinopathy: the EURODIAB IDDM complications study[J]. Diabetologia, 1995, 38(4): 437-444. DOI: 10.1007/BF00410281.
8.	黎曉新, 許迅. 對《與<我國糖尿病視網膜病變篩查的圖像采集及閱片指南(2017年)>作者的商榷》的回復[J]. 中華眼科雜志, 2019, 55(4): 257-258. DOI: 10.3760/cma.j.issn.0412-4081.2019.04.005.Li XX, Xu X. Reply to “Discussion with the authors of guidelines for image collection and film reading for screening diabetic retinopathy in China (2017)”[J]. Chin J Ophthalmol, 2019, 55(4): 257-258. DOI: 10.3760/cma.j.issn.0412-4081.2019.04.005.
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10.	Liegl R, Liegl K, Ceklic L, et al. Nonmydriatic ultra-wide-field scanning laser ophthalmoscopy (Optomap) versus two-field fundus photography in diabetic retinopathy[J]. Ophthalmologica, 2014, 231(1): 31-36. DOI: 10.1159/000355092.
11.	李占峰, 李志清, 劉巨平, 等. 免散瞳超廣角成像系統與免散瞳兩個視野45°數碼成像系統對糖尿病視網膜病變快速篩查結果的評估[J]. 中華眼底病雜志, 2016, 32(3): 243-247. DOI: 10.3760/cma.j.issn.1005-1015.2016.03.004.Li ZF, Li ZQ, Liu JP, et al. Nonmydriatic ultrawide field retinal imaging system and nonmydriatic two-field digital fundus photography system in a large-scale diabetic retinopathy screening[J]. Chin J Ocul Fundus Dis, 2016, 32(3): 243-247. DOI: 10.3760/cma.j.issn.1005-1015.2016.03.004.
12.	中華醫學會糖尿病學分會. 中國2型糖尿病防治指南(2020年版)[J]. 中華糖尿病雜志, 2021, 13(4): 315-409. DOI: 10.3760/cma.j.cn115791-20210221-00095.Diabetes Society of Chinese Medical Association. Chinese guidelines for the prevention and treatment of type 2 diabetes (2020 edition)[J]. Chin J Diabetes Mellitus, 2021, 13(4): 315-409. DOI: 10.3760/cma.j.cn115791-20210221-00095.
13.	中華醫學會眼科學會眼底病學組. 我國糖尿病視網膜病變臨床診療指南(2014年)[J]. 中華眼科雜志, 2014, 50(11): 851-865. DOI: 10.3760/cma.j.issn.0412-4081.2014.11.014.Ocular Fundus Diseases Group of Ophthalmology Society of Chinese Medical Association. Clinical guidelines for diagnosis and treatment of diabetic retinopathy in China (2014)[J]. Chin J Ophthalmol, 2014, 50(11): 851-865. DOI: 10.3760/cma.j.issn.0412-4081.2014.11.014.
14.	Oden NL. Estimating kappa from binocular data[J]. Stat Med, 1991, 10(8): 1303-1311. DOI: 10.1002/sim. 4780100813.
15.	Stefansson E, Bek T, Porta M, et al. Screening and prevention of diabetic blindness[J]. Acta Ophthalmol Scand, 2000, 78(4): 374-385. DOI: 10.1034/j.1600-0420.2000.078004374.
16.	Silva PS, Cavallerano JD, Sun JK, et al. Nonmydriatic ultrawide field retinal imaging compared with dilated standard 7-field 35-mm photography and retinal specialist examination for evaluation of diabetic retinopathy[J]. Am J Ophthalmol, 2012, 154(3): 549-559. DOI: 10.1016/j.ajo.2012.03.019.
17.	Szeto SKH, Wong R, Lok J, et al. Nonmydriatic ultrawide field scanning laser ophthalmoscopy compared with dilated fundal examination for assessment of diabetic retinopathy and diabetic macular oedema in Chinese individuals with diabetes mellitus[J]. Br J Ophthalmol, 2019, 103(9): 1327-1331. DOI: 10.1136/bjophthalmol-2018-311924.
18.	Maruyama-Inoue M, Kitajima Y, Mohamed S, et al. Sensitivity and specificity of high-resolution wide field fundus imaging for detecting neovascular age-related macular degeneration[J/OL]. PLoS One, 2020, 15(8): e0238072[2020-08-21]. https://pubmed.ncbi.nlm.nih.gov/32822418/. DOI: 10.1371/journal.pone.0238072.
19.	鄒海東, 何明光. 積極開展社區糖尿病視網膜病變篩查和早期干預工作[J]. 中華眼科雜志, 2016, 52(11): 801-804. DOI: 10.3760/cma.j.issn.0412-4081.2016.11.001.Zou HD, He MG. Active screening and early intervention of diabetic retinopathy in community service[J]. Chin J Ophthalmol, 2016, 52(11): 801-804. DOI: 10.3760/cma.j.issn.0412-4081.2016.11.001.
20.	彭金娟, 黃建南, 陸麗娜, 等. 糖尿病視網膜病變遠程篩查系統的研究進展[J]. 中華眼科雜志, 2016, 52(11): 868-871. DOI: 10.3760/cma.j.issn.0412-4081.2016.11.014.Peng JJ, Huang JN, Lu Lina, et al. Research advances in diabetic retinopathy telescreening systems[J]. Chin J Ophthalmol, 2016, 52(11): 868-871. DOI: 10.3760/cma.j.issn.0412-4081.2016.11.014.

1. Cheung N, Mitchell P, Wong TY. Diabetic retinopathy[J]. Lancet, 2010, 376(9735): 124-136. DOI: 10.1016/S0140-6736(09)62124-3.
2. Mohamed Q, Gillies MC, Wong TY. Management of diabetic retinopathy: a systematic review[J]. JAMA, 2007, 298(8): 902-916. DOI: 10.1001/jama.298.8.902.
3. Wang LZ, Cheung CY, Tapp RJ, et al. Availability and variability in guidelines on diabetic retinopathy screening in Asian countries[J]. Br J Ophthalmol, 2017, 101(10): 1352-1360. DOI: 10.1136/bjophthalmol-2016-310002.
4. Nguyen HV, Tan GS, Tapp RJ, et al. Cost-effectiveness of a national telemedicine diabetic retinopathy screening program in Singapore[J]. Ophthalmology, 2016, 123(12): 2571-2580. DOI: 10.1016/j.ophtha.2016.08.021.
5. Scanlon PH. The English National Screening Programme for diabetic retinopathy 2003-2016[J]. Acta Diabetol, 2017, 54(6): 515-525. DOI: 10.1007/s00592-017-0974-1.
6. Thomas RL, Dunstan FD, Luzio SD, et al. Prevalence of diabetic retinopathy within a national diabetic retinopathy screening service[J]. Br J Ophthalmol, 2015, 99(1): 64-68. DOI: 10.1136/bjophthalmol-2013-304017.
7. Aldington SJ, Kohner EM, Meuer S, et al. Methodology for retinal photography and assessment of diabetic retinopathy: the EURODIAB IDDM complications study[J]. Diabetologia, 1995, 38(4): 437-444. DOI: 10.1007/BF00410281.
8. 黎曉新, 許迅. 對《與<我國糖尿病視網膜病變篩查的圖像采集及閱片指南(2017年)>作者的商榷》的回復[J]. 中華眼科雜志, 2019, 55(4): 257-258. DOI: 10.3760/cma.j.issn.0412-4081.2019.04.005.Li XX, Xu X. Reply to “Discussion with the authors of guidelines for image collection and film reading for screening diabetic retinopathy in China (2017)”[J]. Chin J Ophthalmol, 2019, 55(4): 257-258. DOI: 10.3760/cma.j.issn.0412-4081.2019.04.005.
9. Wong TY, Cheung CM, Larsen M, et al. Diabetic retinopathy[J/OL]. Nat Rev Dis Primers, 2016, 2: 16012[2016-03-17]. https://pubmed.ncbi.nlm.nih.gov/27159554/. DOI: 10.1038/nrdp.2016.12.
10. Liegl R, Liegl K, Ceklic L, et al. Nonmydriatic ultra-wide-field scanning laser ophthalmoscopy (Optomap) versus two-field fundus photography in diabetic retinopathy[J]. Ophthalmologica, 2014, 231(1): 31-36. DOI: 10.1159/000355092.
11. 李占峰, 李志清, 劉巨平, 等. 免散瞳超廣角成像系統與免散瞳兩個視野45°數碼成像系統對糖尿病視網膜病變快速篩查結果的評估[J]. 中華眼底病雜志, 2016, 32(3): 243-247. DOI: 10.3760/cma.j.issn.1005-1015.2016.03.004.Li ZF, Li ZQ, Liu JP, et al. Nonmydriatic ultrawide field retinal imaging system and nonmydriatic two-field digital fundus photography system in a large-scale diabetic retinopathy screening[J]. Chin J Ocul Fundus Dis, 2016, 32(3): 243-247. DOI: 10.3760/cma.j.issn.1005-1015.2016.03.004.
12. 中華醫學會糖尿病學分會. 中國2型糖尿病防治指南(2020年版)[J]. 中華糖尿病雜志, 2021, 13(4): 315-409. DOI: 10.3760/cma.j.cn115791-20210221-00095.Diabetes Society of Chinese Medical Association. Chinese guidelines for the prevention and treatment of type 2 diabetes (2020 edition)[J]. Chin J Diabetes Mellitus, 2021, 13(4): 315-409. DOI: 10.3760/cma.j.cn115791-20210221-00095.
13. 中華醫學會眼科學會眼底病學組. 我國糖尿病視網膜病變臨床診療指南(2014年)[J]. 中華眼科雜志, 2014, 50(11): 851-865. DOI: 10.3760/cma.j.issn.0412-4081.2014.11.014.Ocular Fundus Diseases Group of Ophthalmology Society of Chinese Medical Association. Clinical guidelines for diagnosis and treatment of diabetic retinopathy in China (2014)[J]. Chin J Ophthalmol, 2014, 50(11): 851-865. DOI: 10.3760/cma.j.issn.0412-4081.2014.11.014.
14. Oden NL. Estimating kappa from binocular data[J]. Stat Med, 1991, 10(8): 1303-1311. DOI: 10.1002/sim. 4780100813.
15. Stefansson E, Bek T, Porta M, et al. Screening and prevention of diabetic blindness[J]. Acta Ophthalmol Scand, 2000, 78(4): 374-385. DOI: 10.1034/j.1600-0420.2000.078004374.
16. Silva PS, Cavallerano JD, Sun JK, et al. Nonmydriatic ultrawide field retinal imaging compared with dilated standard 7-field 35-mm photography and retinal specialist examination for evaluation of diabetic retinopathy[J]. Am J Ophthalmol, 2012, 154(3): 549-559. DOI: 10.1016/j.ajo.2012.03.019.
17. Szeto SKH, Wong R, Lok J, et al. Nonmydriatic ultrawide field scanning laser ophthalmoscopy compared with dilated fundal examination for assessment of diabetic retinopathy and diabetic macular oedema in Chinese individuals with diabetes mellitus[J]. Br J Ophthalmol, 2019, 103(9): 1327-1331. DOI: 10.1136/bjophthalmol-2018-311924.
18. Maruyama-Inoue M, Kitajima Y, Mohamed S, et al. Sensitivity and specificity of high-resolution wide field fundus imaging for detecting neovascular age-related macular degeneration[J/OL]. PLoS One, 2020, 15(8): e0238072[2020-08-21]. https://pubmed.ncbi.nlm.nih.gov/32822418/. DOI: 10.1371/journal.pone.0238072.
19. 鄒海東, 何明光. 積極開展社區糖尿病視網膜病變篩查和早期干預工作[J]. 中華眼科雜志, 2016, 52(11): 801-804. DOI: 10.3760/cma.j.issn.0412-4081.2016.11.001.Zou HD, He MG. Active screening and early intervention of diabetic retinopathy in community service[J]. Chin J Ophthalmol, 2016, 52(11): 801-804. DOI: 10.3760/cma.j.issn.0412-4081.2016.11.001.
20. 彭金娟, 黃建南, 陸麗娜, 等. 糖尿病視網膜病變遠程篩查系統的研究進展[J]. 中華眼科雜志, 2016, 52(11): 868-871. DOI: 10.3760/cma.j.issn.0412-4081.2016.11.014.Peng JJ, Huang JN, Lu Lina, et al. Research advances in diabetic retinopathy telescreening systems[J]. Chin J Ophthalmol, 2016, 52(11): 868-871. DOI: 10.3760/cma.j.issn.0412-4081.2016.11.014.

Chinese Journal of Ocular Fundus Diseases

Compared non-mydriatic two-field 45° fundus imaging methods with non-mydriatic two ultra-widefield fundus imaging in a large-scale diabetic retinopathy screening

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