Validation of Smartphone Based Retinal Photography for Diabetic Retinopathy Screening

Validation of Smartphone Based Retinal Photography for Diabetic Retinopathy Screening
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DOI:
10.1371/journal.pone.0138285
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发表时间:
2015-09-24
期刊:
影响因子:
3.7
通讯作者:
Mohan, Viswanathan
Mohan, Viswanathan
中科院分区:
综合性期刊3区
文献类型:
--
作者:
Rajalakshmi, Ramachandran;Arulmalar, Subramanian;Mohan, Viswanathan

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目的 与 7 标准视野数字视网膜摄影相比,评估“手机眼底”(FOP) 相机(一种基于智能手机的视网膜成像系统)作为糖尿病视网膜病变 (DR) 检测和 DR 严重程度筛查工具的敏感性和特异性。设计单中心、前瞻性、比较性仪器验证研究。方法 301 名 2 型糖尿病患者(602 只眼)使用卡尔蔡司眼底相机和本土 FOP 进行标准七视野数字眼底摄影,印度南部的一家三级护理糖尿病中心。由两名独立的视网膜专家使用改良的糖尿病视网膜病变早期治疗研究分级系统进行了 DR 分级,评估了是否存在增殖性 DR (PDR) 或糖尿病性黄斑水肿。结果 参与者的平均年龄为 53.5 +/- 9.6 岁,糖尿病的平均病程为 53.5 +/- 9.6 岁。 12.5 +/- 7.3 年。Zeiss 相机显示 43.9% 患有非增殖性 DR(NPDR),15.3% 患有 PDR,而 FOP 相机显示 40.2% 患有 NPDR,15.3% 患有 PDR。通过 FOP 检测任何 DR 的敏感性和特异性为 92.7%(95% CI 87.8-96.1)和分别为 98.4%(95% CI 94.3-99.8),卡帕(kappa)一致性为 0.90(95% CI-0.85-0.95 p)
AimTo 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.DesignSingle-site, prospective, comparative, instrument validation study.Methods301 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.ResultsThe 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 (kappa) agreement was 0.90 (95% CI-0.85-0.95 p