中国散瞳手持式眼底相机用于糖尿病视网膜病变筛查视网膜成像的验证：一项前瞻性比较研究。
Validation of handheld fundus camera with mydriasis for retinal imaging of diabetic retinopathy screening in China: a prospective comparison study.
作者信息
Xiao Baixiang, Liao Qinghua, Li Yanping, Weng Fan, Jin Ling, Wang Yanfang, Huang Wenyong, Yi Jinglin, Burton Matthew J, Yip Jennifer Ly
机构信息
The State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-sen University, Guangzhou, China
Zhenjiang District Hospital, Shaoguan, China.
出版信息
BMJ Open. 2020 Oct 29;10(10):e040196. doi: 10.1136/bmjopen-2020-040196.
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.
目的
探讨在中国使用手持眼底相机检测糖尿病视网膜病变（DR）的临床有效性。
设计与场所
在中国广东省的一家医院和一家社区筛查诊所，对手持眼底相机与标准验证仪器在检测DR方面进行前瞻性比较研究。
参与者
年龄在18岁及以上的糖尿病患者，能够提供知情同意书并同意接受散瞳眼部检查，包括手持检测和标准台式相机检查。
主要和次要观察指标
主要观察指标是手持眼底相机（索引测试）与标准相机相比，识别出的可转诊DR（R2及以上）患者的比例。次要观察指标是比较每次检测获得的可分级图像的比例。
结果
在本研究中，我们在散瞳状态下用两台相机分别检查了304人（608只眼）。手持相机检测出119只眼（19.5%）有某种程度的DR，其中81只眼（13.3%）可转诊，而标准相机检测出132只眼（21.7%）有某种程度的DR，83只眼（13.7%）可转诊。虽然McNemar检验未检测到两台相机之间有显著差异，但标准相机似乎发现了更多可转诊DR的眼睛。在通过台式相机获得图像的608只眼中，598只眼（98.4%）的图像质量足以进行分级，12只眼（1.9%）的图像不可分级。通过手持相机，590只眼（97.0%）可分级，20只眼（3.2%）的图像不可分级。两台相机在视网膜病变的所有级别上对视网膜病变和黄斑病变的诊断都达成了高度一致。
结论
虽然手持眼底相机在临床眼底检查中不能取代标准台式相机，但在中国基层DR初步筛查中显示出了有前景的作用。为确保图像质量，需要散瞳。
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