ISRCTN39068025
Completed
未知
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 sites80 target enrollmentStarted: August 11, 2010Last updated:
Overview
- Phase
- 未知
- Status
- Completed
- Sponsor
- Dr. F.P. Fischer Stichting (Netherlands)
- Enrollment
- 80
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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.)
Investigators
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