Medical therapy of keratoconus with Riboflavin/Ultraviolet-A collagen Cross-Linking and investigation of the corneal stromal and Keratocytes modifications apoptosis and stromal repopulation with confocal microscopy and topo-aberrometric link firstly in vivo. Validation of the previous results ex vivo in animal and human enucleated eyes in human patients affected from progressive keratoconus. - X Linking

• Conditions: Patients affected by keratoconus worsening; MedDRA version: 6.1Level: PTClassification code 10023353

• Registration Number: EUCTR2006-000908-17-IT
• Lead Sponsor: AZIENDA OSPEDALIERA SENESE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

- Male and female gender - Age 14-60 years - patients subscribing specific informed consent - progressive keratoconus and corneal ectasia clinically and topoaberrometrically documented - corneal thikness / 400 microns
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- patients affected by other corneal desease - corneal thikness 400 microns - patients affected by HSV keratitis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified