Diagnostic Capacity of Keratoconus Match Index and Keratoconus Match Probability in Forme Fruste Keratoconus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Keratoconus Match Index (KMI)
研究概览
简要总结
Primary objective of this study was to evaluate the diagnostic capability of keratoconus match index (KMI) and keratoconus match probability (KMP) indexes in forme fruste keratoconus (FFK), and their association with a series of Pentacam-derived keratconus (KC) indexes. KMI and KMP parameters are KC-specifc indexes that are measured by Ocular Response Analyzer (ORA), based on the distinct ORA-derived waveform characteristics of KC eyes.
Study participants were recruited from the Cornea Outpatient service in a consecutive if eligible basis. Two study groups were formed: a) FFK group (FFKG) that included patients diagnosed with FFK, and, b) Control group (CG) was formed by refractive surgery candidates.
All ORA (Reichert Ophthalmic Instrument, Buffalo, NY, USA, software version: 3.01)and Pentacam (Pentacam HR, Oculus Optikgerate GmbH, Heidelberg, Germany)measurements were performed by the same experienced operator in a consistent way
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
- •diagnosis of keratoconus KC in the fellow eye according to the Amsler-Krumleich criteria (FFKG)
- •KISA index between 60 and 100% in the FFK eye (FFKG)
- •lack of any KC-related findings / signs in the slit-lamp biomicroscopy (FFKG)
- •uneventful ophthalmologic history (CG)
- •no indications of corneal pathology in slit-lamp biomicroscopy and Placido disk-based videokeratography (CG)
- •KISA index value less than 60% (CG)
排除标准
- •for both study groups:
- •previous incisional eye surgery
- •corneal scars and opacities
- •history of herpetic keratitis, severe eye dryness
- •pregnancy or nursing
- •current corneal infection
- •suspicion for glaucoma
- •IOP lowering treatment
- •underlying autoimmune disease
结局指标
主要结局
Keratoconus Match Index (KMI)
时间窗: one day
KMI is the outcome of a neural network calculation of seven ORA-derived waveform scores and represents the similarity of the waveform of the examined eye against the same average waveform scores of the keratoconus eyes in the machine's database. Receiver operating characteristics (ROC) curves were applied to determine the overall predictive accuracy of KMI parameter,as described by the area under the curve (AUC), in differentiating FFK cases from normal ones. The impact of Pentacam-derived KC related indexes on KMI was assessed with stepwise forward multivariate regression analysis.
次要结局
未报告次要终点
研究者
Georgios Labiris
Senior Lecturer of Ophthalmology
Democritus University of Thrace