Repeatability, Reliability and Reproducibility of Pentacam-derived Curvature and Wavefront Aberrations of Posterior Corneal Surface, in Keratoconic and Cross-linked Corneas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Variability of posterior corneal surface curvature and aberrometric measurements within and between sessions and within and between observers.
研究概览
简要总结
Primary objective of this study was to assess the intrasession, intersession and interobserver variability of the Pentacam-derived curvature and zernike coefficients in back surface of normal, keratoconic and crosslinked corneas.
详细描述
The Pentacam Classic (Oculus Optikgerate GmbH, Heidelberg, Germany, software version 1.14r04) was used for the sake of the study.Three study groups were formed: 1) Normal 2) Keratoconus group (KC) included patients with progressive keratoconus and 3) Collagen-Cross-linking group (CXL) included keratoconus patients that had been treated with uneventful CXL at least on year prior to their enrollment in the study.
Three consecutive scans were obtained by two experienced operators. The same procedure was repeated within two weeks for the assessment of intersession variability. In all cases acceptable maps had at least 10.0mm of corneal coverage. Keratometry (K), asphericity (Q), best-fit toric ellipsoid radius (Rs), eccentricity (ecc) and aberrometry (6.0mm pupil diameter), were analyzed. Furthermore we calculated and studied CRMS and CLRMS in order to better appreciate the visual significance of HOAs. Precision (Pre), repeatability (COR) and intraclass correlation coefficient (ICC), were calculated for evaluating intrasession and intersession repeatability. Bland-Altman analysis was used for assessing interobserver repeatability.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ideal refractive surgery candidate (Normal Group)
- •Progressive keratoconus (Keratoconus group)
- •Corneal collagen cross linking (CxL) treatment at least one year prior to enrollment (CxL group)
排除标准
- •(Normal Group)
- •No indications of corneal pathology in slit-lamp biomicroscopy and Placido disk-based videokeratography
- •Uneventful ophthalmologic history
- •All groups:
- •Suspicion of glaucoma
- •history of herpetic keratitis
- •corneal scarring
- •severe eye dryness
- •pregnancy or nursing
- •current corneal infection
- •underlying autoimmune disease
结局指标
主要结局
Variability of posterior corneal surface curvature and aberrometric measurements within and between sessions and within and between observers.
时间窗: 2 weeks
The Pentacam Classic (Oculus Optikgerate GmbH, Heidelberg, Germany, software version 1.14r04) was used for the sake of the study. Three consecutive scans were obtained by two experienced operators for the assessment of intrasession and interobserver variability. The same procedure was repeated within two weeks for the assessment of intersession variability.Bland-Altman plots were used to evaluate agreement between the 2 operators. The reliability of all measurements was evaluated by means of the intraclass correlation coefficient(ICC).
次要结局
未报告次要终点
研究者
Georgios Labiris
Lecturer
Democritus University of Thrace