German Corneal Cross Linking Register

Condition(s) studied

Investigational drug(s) / intervention(s)

CCL (Corneal Cross Linking): Apply Riboflavin 0.1% in Dextran 500 20% in NaCl solution Illuminate with UV-light of 365 nm wave-length and 3.0 mW/cm² intensity at 5 cm distance

Study summary

Corneal Cross Linking is new treatment modality for patients with keratoconus. A keratoconus is characterized by progressive bulging and thinning of the eye's cornea. Keratoconus is a potentially severely sight impairing condition that may necessitate corneal transplantation in the progressive state.

Corneal Cross Linking is designed to

* increase the cornea's mechanical stability
* to stop progression of bulging and thinning of the cornea
* to prevent the need for corneal transplantation

Corneal Cross Linking is performed by

1. Applying Riboflavin (Vitamin B2) eye drops every 2 minutes for 30 minutes to the cornea
2. Illuminating the cornea with UV-light

This register of Corneal Cross Linking procedures performed in Germany serves to

* gather long-term results
* detect rare complications and side-effects
* evaluate the efficacy in a large number of patients

Eligibility

Primary outcome measure(s)

• Visual Acuity — 172 to 3396 days
  Corrected Visual Acuity after crosslinking at the latest follow up examination
• Postoperative K Max — 172 to 3396 days
  K max after Crosslinking
• Sphere — 172 to 3396 days
  Sphere values after crosslinking at lastest-follow-up
• Cylinder — 172 to 3396 days
  Refractive cylinder after Crosslinking at latest follow-up

Trial sites (2)

More Suphi Taneri trials in Germany

Other trials for the same condition