Transepithelial corneal collagen crosslinking using iontophoresis: clinical results at 1 year

Session Details

Session Title: Cross-Linking

Session Date/Time: Sunday 06/09/2015 | 08:00-09:30

Paper Time: 08:51

Venue: Main Auditorium

First Author: : M.Cassagne FRANCE

Co Author(s): :    A. Thevenin   I. Delafoy   P. Fourine   B. Cochener   F. Malecaze        

Abstract Details

Purpose:

Corneal collagen crosslinking has proved its efficacy for the stabilization of progressive keratoconus using the « epi-off » conventional procedure but presents potential complications, mostly related to desepithelialization.
The aim of the present study was to evaluate a new « epi-on » technique of riboflavin administration, using iontophoresis

Setting:

This non-inferiority, prospective, multicentric, randomized, parallel-arm study, compared the crosslinking using iontophoresis (I- CXL) to the conventional crosslinking (C-CXL). CHU Toulouse, Purpan Hospital, Toulouse, France.

Methods:

The C-CXL procedure was performed in accordance with the Dresden protocol.
The I-CXL involved the administration in the cornea of a new formulation of charged riboflavin (Ricrolin+®) applying a weak electrical current of 1 mA for 5 minutes. This application of riboflavin was followed by an accelerated UVA irradiation at 10mW/cm2 for 9 minutes.
Between May 2013 and April 2014, eighty patients with progressive keratoconus were enrolled.
The primary outcome was the stability of keratometric values at 1 year and the secondary outcomes were: riboflavin corneal concentration by fluorophotometry, pain, visual acuity, endothelial cell count, OCT, confocal microscopy and complications.

Results:

Peroperative corneal concentration of riboflavin was 2.5 times lower in the corneas treated with I-CXL (752.8 ng/mL) compared to those treated with C-CXL (1902 ng/mL) (p<0.05).
Postoperative pain was significantly less important for I-CXL treated patients.
At 1 year, the keratometric values were stable in the 2 groups (p<0.05): 58.82% of I-CXL patients were stable +/- 1D vs 54.17% of C-CXL patients. We observed a regression of more than 1D in 23.53% of I-CXL patients vs 33.33% of 
C-CXL patients. Using OCT, the stromal demarcation line was inconstantly observed and less deep in the I-CXL group (100 to 250 microns) compared to the C-CXL group (250 to 350 microns).

Conclusions:

These results show less penetration of riboflavin using I-CXL but the main objective that is the keratoconus stabilization at 1 year is obtained, with comparable results to the gold-standard CXL. These results of the 40 first patients are promising, but a largest cohort and a longer follow-up are needed.

Financial Interest:

NONE