NCT02456961

Standard Corneal Collagen Crosslinking Versus Transepithelial Corneal Crosslinking by Iontophoresis of Riboflavin

Comparative Study of Results of Standard Corneal Collagen Crosslinking Versus Transepithelial Corneal Crosslinking by Iontophoresis of Riboflavin: a Randomized Control Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Ufa Eye Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The standard CXL technique involves removal of the epithelium to enable riboflavin to penetrate into stromal tissue, to avoid epithelial debridement and increasing the patient's comfort and safety transepithelial corneal crosslinking (CXL) was suggested. Iontophoresis of riboflavin is one of approach for riboflavin impregnation. In this study, the investigators compared the results of standard corneal crosslinking (CXL) and transepithelial CXL via iontophoresis of riboflavin after 24 months follow up.

Conditions

• Keratoconus

Interventions

Type	Name	Description
PROCEDURE	iontophoresis of riboflavin
PROCEDURE	epithelium-off
PROCEDURE	Corneal collagen crosslinking	Standard surface UVA irradiation (370 nm, 3 mW/cm2; UFalink, Russian Federation) was then applied at a 5-cm distance for 30 minutes. During UVA exposure, hypotonic riboflavin drops were continued every 2 minutes.
DEVICE	galvanizator, Potok-1	Device for providing iontophoresis procedure
DRUG	Dextralink	Riboflavin 0,1% + Dextran T-500
DRUG	Riboflavin 0,1%
DEVICE	UFalink	device for UVA irradiation - providing UVA light - 370 nm, 3 mW/cm2

Timeline

• Start date: 2010-01-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2015-05-29
• Last updated: 2015-05-29