Partial endothelial trepanation in addition to anterior lamellar keratoplasty in keratoconus: a randomised controlled open-label parallel interventional trial

Dr. F.P. Fischer Stichting (Netherlands)0 个研究点目标入组 80 人开始时间: 2010年8月11日最近更新: 2020年8月3日

适应症

试验速览

暂无简介。

•1. Aged equal or above 18 years, either sex
•2. Keratoconus as defined and classified by:
•2.1. Presence of corneal thinning and protrusion on slit-lamp examination
•2.2. Topographic criteria according to keratometry, I-S, astigmatism, and skew percentage (KISA%) index (greater than 100%)
•2.3. Mean corneal curvature map
•3. Decreased best corrected visual acuity due to corneal scarring or contact lens intolerance

•1. Prior corneal surgery, cross linking, refractive surgery or other treatment modalities
•2. (Localised) corneal thickness less than 200 µm
•3. Associated corneal endothelial disease on specular microscopy as defined by:
•3.1. Less than 1500 endothelial cells per mm^2
•3.2. Polymegathism greater than 0.3
•3.3. Pleomorphism less than 0.6 (all are measurements of endothelial dysfunction)
•4. Gross ophthalmic pathology surpassing keratoconus as cause of decreased visual acuity
•5. Keratoconus-like disease (keratoglobus, pellucid marginal degeneration)
•6. Associated corneal anomalies (microcornea, macrocornea, buphthalmos, Peters syndrome, iridocorneal endothelial [ICE]-syndrome, etc.)

发起方

Dr. F.P. Fischer Stichting (Netherlands)