Barr J T, Schechtman K B, Fink B A, Pierce G E, Pensyl C D, Zadnik K, Gordon M O
The Ohio State University College of Optometry Columbus, 43210-1240, USA.
Cornea. 1999 Jan;18(1):34-46.
The multicenter Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study is a prospective, observational study of 1,209 keratoconus patients. We report on the prevalence of corneal scarring in these patients. We also report on the test-retest repeatability of corneal scar documentation at the slit-lamp biomicroscope by trained clinicians and by masked photograph readers and on the scarring-status agreement at baseline between clinicians and photograph readers.
Clinicians and masked photograph readers graded each cornea as to scarring status. Patients were examined by clinicians, and their corneas were photographed at baseline (2,297 nongrafted eyes of 1,209 patients) and at a repeated visit (258 nongrafted eyes of 138 patients). These photographs were evaluated by the masked readers at the CLEK Photography Reading Center (CPRC). Clinicians reported corneal scars in right eyes at baseline as "definitely not present" in 53.9%, "probably not present" in 8.4%, "probably present" in 8.2%, and "definitely present" in 29.4% of patients. A weighted kappa statistic of 0.83 (95% confidence interval from 0.78 to 0.88) indicates that agreement is excellent between baseline and repeated assessments for the presence of a corneal scar by clinicians.
Agreement is very good between baseline and repeated photograph-reader assessments for the presence of a scar, with a weighted kappa of 0.77 (95% confidence interval, 0.72-0.82). The kappa statistic comparing photograph-reader scarring assessments with clinician results was 0.69 (95% confidence interval, 0.66-0.71).
The data also suggest better agreement between clinicians and readers when Vogt's striae and corneal nerves were observed. The data also suggest better agreement when corneal staining was not observed by the photograph readers. The CLEK Study protocol for determining the presence of scars is highly repeatable.
圆锥角膜多中心协作纵向评估(CLEK)研究是一项对1209例圆锥角膜患者进行的前瞻性观察性研究。我们报告这些患者角膜瘢痕的患病率。我们还报告了经过培训的临床医生和蒙面照片阅读者在裂隙灯生物显微镜下记录角膜瘢痕的重测重复性,以及临床医生和照片阅读者在基线时瘢痕状态的一致性。
临床医生和蒙面照片阅读者对每只角膜的瘢痕状态进行分级。临床医生对患者进行检查,并在基线时(1209例患者的2297只未移植眼)和复诊时(138例患者的258只未移植眼)对其角膜进行拍照。这些照片由CLEK摄影阅读中心(CPRC)的蒙面阅读者进行评估。临床医生报告,在基线时,右眼角膜瘢痕在53.9%的患者中“肯定不存在”,在8.4%的患者中“可能不存在”,在8.2%的患者中“可能存在”,在29.4%的患者中“肯定存在”。加权kappa统计量为0.83(95%置信区间为0.78至0.88),表明临床医生对角膜瘢痕存在情况的基线评估和重复评估之间的一致性极佳。
对于瘢痕的存在,基线照片阅读者评估和重复照片阅读者评估之间的一致性非常好,加权kappa为0.77(95%置信区间为0.72 - 0.82)。将照片阅读者的瘢痕评估结果与临床医生的结果进行比较的kappa统计量为0.69(95%置信区间为0.66 - 0.71)。
数据还表明,当观察到Vogt条纹和角膜神经时,临床医生和阅读者之间的一致性更好。数据还表明,当照片阅读者未观察到角膜染色时,一致性更好。CLEK研究中确定瘢痕存在的方案具有高度可重复性。