Retina. 2008 Mar;28(3 Suppl):S47-54. doi: 10.1097/IAE.0b013e31815e987f.
To evaluate the utility of remote digital fundus imaging as compared to indirect ophthalmoscopy to screen for retinopathy of prematurity (ROP).
This was a prospective, multicenter, masked clinical trial. Infants <31 weeks gestational age and <1000 g at birth were eligible for enrollment. Eligible enrolled infants were screened for ROP employing serial fundus imaging followed by indirect ophthalmoscopy. The main outcome measures were diagnostic sensitivity, specificity, positive and negative predictive values, and accuracy of image interpretation compared to ophthalmoscopy.
Fifty-one infants (102 eyes) meeting eligibility criteria were enrolled between February 2001 and February 2002. Mean weekly examinations per infant (+/-SD) were 5.73 +/- 3.22 (median 7; range 2-10). For the purposes of this study, the reading center established a definition of ROP seen on digital fundus images deemed sufficiently severe (termed clinically significant ROP, or CSROP) to warrant on-site examination by an ophthalmologist experienced in ROP. CSROP developed in 59 of 102 eyes (57.8%; 31 right eyes and 28 left eyes). Of the eyes with CSROP, 22% (13/59; 7 right eyes and 6 left eyes) progressed to ROP severe enough to require treatment according to the criteria of the Early Treatment for ROP Randomized Trial. Using onsite indirect ophthalmoscopic diagnosis as the reference standard, CSROP was identified by digital images with a sensitivity of 92% (94% right eyes and 89% left eyes) and specificity of 37.21% (40% right eyes and 35% left eyes), and Early Treatment for Retinopathy of Prematurity (ETROP) prethreshold Type I with a sensitivity of 92% (86% right eyes and 100% left eyes) and specificity of 67.39% (67% right eyes and 68% left eyes).
Remote interpretation of digital fundus images is a useful adjunct to conventional bedside ROP screening by indirect ophthalmoscopy. Diagnostic sensitivity in this study was excellent. It was highly unlikely that severe ROP would be missed when image quality was high. Differences between the two screening approaches in timing of diagnosis of CSROP and ETROP were not statistically significant. Remote digital fundus imaging as deployed in this study is unlikely to supplant bedside ophthalmoscopic examination due to limitations in diagnostic sensitivity, specificity, and accuracy when image quality is poor.
评估与间接检眼镜相比，远程数字眼底成像在筛查早产儿视网膜病变（ROP）中的效用。
这是一项前瞻性、多中心、设盲的临床试验。孕龄<31周且出生体重<1000克的婴儿符合入组条件。符合条件的入组婴儿采用系列眼底成像随后进行间接检眼镜检查来筛查ROP。主要结局指标是与检眼镜检查相比的诊断敏感性、特异性、阳性和阴性预测值以及图像解读的准确性。
2001年2月至2002年2月期间，51名符合入选标准的婴儿（102只眼）入组。每名婴儿平均每周检查次数（±标准差）为5.73±3.22（中位数7；范围2 - 10）。为了本研究的目的，阅读中心制定了一个关于在数字眼底图像上所见的ROP的定义，该ROP被认为严重程度足以（称为临床上有意义的ROP，或CSROP）需要由一名有ROP经验的眼科医生进行现场检查。102只眼中有59只眼（57.8%；31只右眼和28只左眼）发生了CSROP。在发生CSROP的眼中，22%（13/59；7只右眼和6只左眼）进展为ROP，严重程度足以根据ROP随机试验早期治疗标准进行治疗。以现场间接检眼镜诊断作为参考标准，通过数字图像识别CSROP的敏感性为92%（右眼94%，左眼89%），特异性为37.21%（右眼40%，左眼35%），以及早产儿视网膜病变早期治疗（ETROP）阈值前I型的敏感性为92%（右眼86%，左眼100%），特异性为67.39%（右眼67%，左眼68%）。
数字眼底图像的远程解读是传统床边间接检眼镜ROP筛查的有用辅助手段。本研究中的诊断敏感性良好。当图像质量高时，极不可能漏诊严重ROP。两种筛查方法在CSROP和ETROP诊断时间上的差异无统计学意义。由于图像质量差时诊断敏感性、特异性和准确性存在局限性，本研究中所采用的远程数字眼底成像不太可能取代床边检眼镜检查。
