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Completed

NCT Number: NCT00626717

Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus

Background: Corneal cross linking is a procedure that induces collagen cross linking of the corneal stroma due to release of reactive oxygen radicals upon activation of topically applied riboflavine A by UVA exposure. This procedure might be capable of reducing keratocouns progression.

Purpose: Although there are no randomised controlled trials on the effectiveness of corneal cross linking for the treatment of keratoconus it gains more and more importance in the general clinical setting. Therefore, the investigators started such randomised, placebo controlled, double blinded, multicenter trial to find out if this treatment is as effective as it promises to be.

Methods: Randomised, placebo controlled, double blinded, multicenter trial.

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Eye Hospital Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Only early Keratoconus (Contact lens fitting)
  • Progression of Ametropia.
  • Corneal thickness > 450µm

Exclusion criteria

  • Further ophthalmic diseases
  • History of ocular surgery
  • Pregnancy, brest feeding
  • Allergy against Riboflavin
  • End stage Keratoconus

Treatment and study plan

Riboflavin/UVA crosslinking

Procedure

Removal of epithelium. Riboflavin eye drops. UVA exposure.

Sham treatment

Procedure

Fluorescein eye drops. Exposure with blue light

Primary outcomes

  1. Keratoconus progression

    Time frame: 3 years

  2. Endothelial cell loss

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

University Hospital Freiburg

Other

Collaborators

  • Peschke Meditrade, GmbH

Registry information

Acronym: CCL

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Feb 29, 2008
Registry last updated
Jan 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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