Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus (CCL)

University Hospital Freiburg

Status and phase: Completed; Phase 3; Phase 2

Conditions: Keratoconus

Treatments: Procedure: Sham treatment; Procedure: Riboflavin/UVA crosslinking

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00626717

FR-03-CCL

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

1

Experimental group

Treatment:

Procedure: Riboflavin/UVA crosslinking

2

Sham Comparator group

Treatment:

Procedure: Sham treatment