Transepithelial Corneal Cross-linking Using Iontophoresis

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 31, 2014

Primary Completion Date

June 30, 2016

Study Completion Date

September 30, 2016

Conditions
Progressive Keratoconus
Interventions
DEVICE

Cross-linking with iontophoresis

The procedure involves a constant current source and two electrodes. The active electrode is a bath tube, which includes a stainless steel grid, placed into the cup at a minimal distance from the cornea. The reservoir is filled with dextran-free, hypotonic riboflavin-5-phosphate solution. The generator applies a constant current of 1mA for a preset period of 5 min. After the riboflavin administration by iontophoresis, the cornea is irradiated using a UVA lamp of 10mW/cm2 for 9 minutes.

DEVICE

Standard corneal cross-linking

In the standard CL, the epithelium is mechanically removed. Then, a solution of riboflavin is instilled each minute for 30 minutes. Corneas are irradiated using a UVA lamp of 3mW/cm2 for 30 minutes.

Trial Locations (1)

00198

Fondazione G.B. Bietti, IRCCS, Rome

All Listed Sponsors
collaborator

CNR Institute for chemical and physical processes (IPCF), Messina

UNKNOWN

lead

Fondazione G.B. Bietti, IRCCS

OTHER

NCT02117999 - Transepithelial Corneal Cross-linking Using Iontophoresis | Biotech Hunter | Biotech Hunter