Retrospective Digital Computer Analysis of Keratoconus Evolution - REDCAKE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 972
- 试验地点
- 1
- 主要终点
- To obtain a database, containing at least two valid corneal Scheimpflug measurements recorded at least 5 months apart, of 1500 keratoconus patients.
研究概览
简要总结
The purpose of this study is to create a database of keratoconic eyes with two or more corneal topographies/tomographies, at least 5 months apart
详细描述
Title: Keratometry values such as K1, K2 and the angle between these two; Value and location of the thinnest corneal point; Pachymetry progression (radial change of pachymetry); IS value (i.e., ratio of average curvature in superior and inferior sections)
Description:
The primary endpoint is to obtain a database, containing at least two valid corneal biometry measurements (Scheimpflug) recorded at least 5 months apart, for a predetermined number of suitable keratoconus patients.
These data will be used to create a personalized three-dimensional model of the cornea at each time point, which permits classifying corneas according to shape and stage, as well as assessing the influence of patient age, gender, family history and ophthalmic habits (e.g. eye rubbing) on keratoconus progression. Based on corneal changes over time, an estimate of the underlying biomechanical changes will be made. All these data will then be combined to develop software for automated keratoconus detection and progression risk assessment to help ophthalmologists decide when to perform crosslinking on their patients.
The primary variables are the elevation parameters derived directly from the Scheimpflug measuring device export files, along with the demographic and medical information (if available).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 12-40 years.
- •Clinically diagnosed mild or moderate keratoconus in one or both eyes
- •Two or more Scheimpflug measurements (type Pentacam HR, Pentacam AXL, Ziemer Galilei, CSO Sirius) of good technical quality, separated at least five months apart.
排除标准
- •Corneal scarring present in both eyes.
- •Known corneal or retinal pathologies, apart from keratoconus
- •Known ocular procedures/ treatments (including crosslinking)
- •Known systemic diseases (e.g. diabetes, MS, HIV/AIDS, hypertension,...), except allergies
- •Change in contact lenses between measurements (e.g. start wearing lenses, change from corneal to scleral lenses, etc.)
- •Fluorescein drops instilled into the eye before Scheimpflug measurement.
结局指标
主要结局
To obtain a database, containing at least two valid corneal Scheimpflug measurements recorded at least 5 months apart, of 1500 keratoconus patients.
时间窗: 5 months
These data will be used to create a personalized three-dimensional model of the cornea at each time point, which permits classifying corneas according to shape and stage, as well as assessing the influence of patient age, gender, family history and ophthalmic habits (e.g. eye rubbing) on keratoconus progression. Based on corneal changes over time, an estimate of the underlying biomechanical changes will be made.
To develop software to automatically detect keratoconus and estimate the keratoconus progression speed
时间窗: 18 months
The data from Outcome 1 will be combined to develop software for automated keratoconus detection and progression risk assessment to help ophthalmologists decide when to perform cross-linking on their patients.
次要结局
- To improve the predictive model for keratoconus progression speed so it can work using only one single measurement(18 months)
研究者
Jos Rozema
Senior researcher, Dpt of Ophthalmology
University Hospital, Antwerp