Comparison of Two Optical Coherence Tomography Devices in Corneal Epithelial Thickness Maps
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Agreement between two ss-OCT devices in corneal epithelial thickness measurements (LoA in micrometer)
研究概览
简要总结
In keratoconic eyes, the corneal epithelium shows a localized thinning over the cone that is surrounded by an annulus of epithelial thickening. It has been postulated that epithelial thickness mapping can be a sensitive tool for the keratoconus diagnosis. In keratoconus screening the 5 mm diameter of the corneal centrum may be sufficient while studies have shown that the cone apex is located in this area.
Aim of this study is to assess agreement and repeatability of epithelial thickness measurements using two optical coherence tomography devices in healthy and keratoconus corneas.
Secondary objective is to evaluate the differences between healthy and keratoconus eyes using epithelial thickness map data.
This is a prospective monocentric study that includes patients divided into two groups: patients with keratoconus and a control group formed out of patients without corneal pathologies. For each patient only one eye will be included and corneal measurements will be performed, focused on the corneal epithelium thickness.
详细描述
In total 50 eyes of 50 patients will be included, divided into two groups: study group comprised of 20 eyes with diagnosed keratoconus and a control group formed out of 30 healthy eyes.
Patients included in the study will be measured with the corneal acquisition mode, also allowing for epithelium thickness data, on each device without pupil dilatation. After each measurement patients will be asked to blink in order to allow adequate tear-film recovery. Each patient will be measured three times with both devices. Only one visit will be necessary.
The order in which the measurements will be performed (Anterion or MS-39) will be randomised using randomised.org.
The corneal epithelial thickness will be measured as the distance between the air-tear and the epithelium-Bowman interfaces.
Main outcome variable:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient with diagnosed keratoconus (diagnosed using tomography and topography map changes and slit-lamp changes) and patients with healthy cornea
- •Age 21 and older
- •Signed informed consent
排除标准
- •Previous ocular surgery
- •Associated corneal pathologies (e.g. trauma, edema, scarring)
- •In women of childbearing age, a pregnancy test will be performed before inclusion into the study.
结局指标
主要结局
Agreement between two ss-OCT devices in corneal epithelial thickness measurements (LoA in micrometer)
时间窗: 6 months
次要结局
- Repeatability between two ss-OCT devices in corneal epithelial thickness measurements (determination of within-subject standard deviation and Coefficient of variation)(6 months)
研究者
Prim. Prof. Dr. Oliver Findl, MBA
Head of Department of Ophthalmology, Professor, Principal Investigator, MBA
Vienna Institute for Research in Ocular Surgery