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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000908-17-IT

Enrollment

200

Registered

2006-04-21

Start date

2007-01-11

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients affected by keratoconus worsening MedDRA version: 6.1 Level: PT Classification code 10023353

Interventions

Trade Name: Riboflavina Pharmaceutical Form: Solution for injection INN or Proposed INN: Riboflavin vit B2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10-

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: - Treatment and development of the medical therapy of keratoconus with collagen cross linking induced by combined action of riboflavin and ultraviolet-A diode laser irradiation. - Validation of the previous results stromal modifications, keratocytes apoptosis and repopulation firstly in Europe in vivo by Confocal Microscopy and Topo-Aberrometric link - Study of cross-linking surgical techinique and clinical effects. - Prevention and reduction of needs of donors corneal transplants in patients with progressive keratoconus.;Primary end point(s): retardation or stop of keratoconus progression by corneal collagen photopolimeryzation;Secondary Objective: - Study of corneal biomechanical modifications induced by riboflavin/ultraviolet A collagen cross-linking - long term studies and follow up connected with collagen cross-linking - development of corneal cross-linking surgical techinique improving the conservative treatment of keratoconus - comparative statistics analysis before and after corneal cross-linking treatment of progressive keratoconus - development and definition of the guidelines	—

Measure

Time frame

Main Objective: - Treatment and development of the medical therapy of keratoconus with collagen cross linking induced by combined action of riboflavin and ultraviolet-A diode laser irradiation. - Validation of the previous results stromal modifications, keratocytes apoptosis and repopulation firstly in Europe in vivo by Confocal Microscopy and Topo-Aberrometric link - Study of cross-linking surgical techinique and clinical effects. - Prevention and reduction of needs of donors corneal transplants in patients with progressive keratoconus.;Primary end point(s): retardation or stop of keratoconus progression by corneal collagen photopolimeryzation;Secondary Objective: - Study of corneal biomechanical modifications induced by riboflavin/ultraviolet A collagen cross-linking - long term studies and follow up connected with collagen cross-linking - development of corneal cross-linking surgical techinique improving the conservative treatment of keratoconus - comparative statistics analysis before and after corneal cross-linking treatment of progressive keratoconus - development and definition of the guidelines

—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026