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Clinical Trials/ISRCTN39068025
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

Sponsor
Dr. F.P. Fischer Stichting (Netherlands)

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