Iontophoretic Transepithelial Collagen Cross-linking Versus Epithelium-off Collagen Cross-linking in Pediatric Patients. Three Year Follow up.

CompletedOBSERVATIONAL
Enrollment

28

Participants

Timeline

Start Date

January 1, 2013

Primary Completion Date

June 30, 2015

Study Completion Date

June 30, 2015

Conditions
Keratoconus
Interventions
PROCEDURE

corneal cross-linking

"Epithelium-off CXL was performed according to the Siena (Dresden modified) protocol: 2% pilocarpine was instilled 30 minutes before treatment, the epithelium was removed using a blunt knife. An isotonic solution of riboflavin 0.1% and dextran 20% was instilled for 10 minutes of corneal soaking before starting UV-A irradiation. The solution was administered every 3 minutes for a total of 30 minutes of UV-A exposure at 3mW/cm2.~The iontophoresis device was filled with a hypoosmolar riboflavin 0.1% dextran-free solution enriched with ethylenediaminetetraacetic acid and trometamol. The device was then connected to a constant current generator initially set at 0.5 mA and increased to 1.0 mA to find out the individual tolerance. Iontophoresis was then performed for 5 minutes. The corneal device was then removed before performing UVA irradiation. During the irradiation phase (10 mW/cm2 for 9 minutes), good fluorescence was clearly detectable. The total treatment time was 14 minutes."

All Listed Sponsors
lead

Bambino Gesù Hospital and Research Institute

OTHER

NCT03753009 - Iontophoretic Transepithelial Collagen Cross-linking Versus Epithelium-off Collagen Cross-linking in Pediatric Patients. Three Year Follow up. | Biotech Hunter | Biotech Hunter