Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Ophthalmology. 2012 Apr;119(4):771-8. doi: 10.1016/j.ophtha.2011.10.019. Epub 2012 Jan 31.
To determine the sensitivity of time domain optical coherence tomography (OCT) in detecting conversion to neovascular age-related macular degeneration (AMD) in eyes at high risk for choroidal neovascularization (CNV), compared with detection using fluorescein angiography (FA) as the gold standard.
Prospective, multicenter, observational study.
Individuals aged ≥50 years with nonneovascular AMD at high risk of progressing to CNV in the study eye and evidence of neovascular AMD in the fellow eye.
At study entry and every 3 months through 2 years, participants underwent best-corrected visual acuity, supervised Amsler grid testing, preferential hyperacuity perimetry (PHP) testing, stereoscopic digital fundus photographs with FA, and OCT imaging. A central Reading Center graded all images.
The sensitivity of OCT in detecting conversion to neovascular AMD by 2 years, using FA as the reference standard. Secondary outcomes included comparison of sensitivity, specificity, positive predictive value, and negative predictive value of OCT, PHP, and supervised Amsler grid relative to FA for detecting incident CNV.
A total of 98 participants were enrolled; 87 (89%) of these individuals either completed the 24-month visit or exited the study after developing CNV. Fifteen (17%) study eyes had incident CNV confirmed on FA by the Reading Center. The sensitivity of each modality for detecting CNV was: OCT 0.40 (95% confidence interval [CI], 0.16-0.68), supervised Amsler grid 0.42 (95% CI, 0.15-0.72), and PHP 0.50 (95% CI, 0.23-0.77). Treatment for incident CNV was recommended by the study investigator in 13 study eyes. Sensitivity of the testing modalities for detection of CNV in these 13 eyes was 0.69 (95% CI, 0.39-0.91) for OCT, 0.50 (95% CI, 0.19-0.81) for supervised Amsler grid, and 0.70 (95% CI, 0.35-0.93) for PHP. Specificity of the OCT was higher than that of the Amsler grid and PHP.
Time-domain OCT, supervised Amsler grid, and PHP have low to moderate sensitivity for detection of new-onset CNV compared with FA. Optical coherence tomography has greater specificity than Amsler grid or PHP. Among fellow eyes of individuals with unilateral CNV, FA remains the best method to detect new-onset CNV.
与金标准荧光素血管造影（FA）相比，确定时域光相干断层扫描（OCT）检测高危脉络膜新生血管（CNV）的年龄相关性黄斑变性（AMD）患者向新生血管性 AMD 转化的敏感性。
前瞻性、多中心、观察性研究。
年龄≥50 岁、研究眼有非新生血管性 AMD 且有进展为 CNV 的高危因素、对侧眼有新生血管性 AMD 证据的患者。
在研究入组时和之后每 3 个月直至 2 年，患者接受最佳矫正视力、监督阿姆斯勒格检查、偏好性高敏度周边视野检查（PHP）、带有 FA 的立体数字眼底照相和 OCT 成像。中央阅读中心对所有图像进行分级。
OCT 在 2 年内检测到新生血管性 AMD 的敏感性，以 FA 作为参考标准。次要观察指标包括 OCT、PHP 和监督阿姆斯勒格检查与 FA 相比，检测新发 CNV 的敏感性、特异性、阳性预测值和阴性预测值。
共纳入 98 例患者；其中 87 例（89%）完成了 24 个月的随访或在发生 CNV 后退出了研究。15 只（17%）研究眼的 FA 证实存在新发 CNV。各检查方法检测 CNV 的敏感性分别为：OCT 为 0.40（95%置信区间 [CI]，0.16-0.68）、监督阿姆斯勒格检查为 0.42（95% CI，0.15-0.72）、PHP 为 0.50（95% CI，0.23-0.77）。研究研究者建议对 13 只研究眼的新发 CNV 进行治疗。在这 13 只眼，检测方法对 CNV 的检测敏感性分别为：OCT 为 0.69（95% CI，0.39-0.91）、监督阿姆斯勒格检查为 0.50（95% CI，0.19-0.81）、PHP 为 0.70（95% CI，0.35-0.93）。OCT 的特异性高于阿姆斯勒格检查和 PHP。
与 FA 相比，时域 OCT、监督阿姆斯勒格检查和 PHP 检测新发 CNV 的敏感性较低或中等。OCT 的特异性高于阿姆斯勒格检查或 PHP。在单侧 CNV 患者的对侧眼，FA 仍然是检测新发 CNV 的最佳方法。
