Transepithelial Corneal Cross-linking Using Iontophoresis

Not Applicable

Completed

• Conditions: Progressive Keratoconus
• Interventions: Device: Cross-linking with iontophoresis; Device: Standard corneal cross-linking

• Registration Number: NCT02117999
• Lead Sponsor: Fondazione G.B. Bietti, IRCCS

Brief Summary

The purpose of the present Randomized Clinical Trial (RCT) is to compare the efficacy and safety of transepithelial corneal cross-linking using iontophoresis (T-ionto CL) to treat progressive keratoconus in comparison with standard cross-linking (standard CL).

Detailed Description

Keratoconus is a progressive corneal ectatic disease causing visual impairment by inducing irregular astigmatism and corneal opacity. This disorder typically begins during the second decade of life and, in severe forms, may need a corneal transplantation. Corneal cross-linking with riboflavin and UV-A is a procedure intended to halt keratoconus progression. It generates additional chemical bonds between stromal proteins in order to stiffen the corneal tissue. Standard CL includes epithelial removal and stroma soaking with dextran-enriched 0.1% riboflavin solution for 30 minutes before being exposed to ultraviolet-A radiation using a 3mW/cm2 lamp for 30 minutes.

Epithelial debridement exposes the cornea to a risk of side effects, such as pain for the first two post-operative days, temporary loss of visual acuity during the first three months, and serious complications, such as infection and stromal opacity due to corneal scarring.

Iontophoresis is a non invasive technique in which a weak electric current is used to enhance the penetration of hypotonic 0.1% riboflavin-5-phosphate solution into the corneal stroma through the intact epithelium. After iontophoresis, the corneal tissue is irradiated using a 10 mW/cm2 for 9 minutes (T-ionto CL). From previous experimental work (Lombardo M. et al. JCRS 2014 and JCRS 2015), the investigators provided evidence that T-ionto CL increases the stiffness of human corneas with results almost comparable with standard CL. The new procedure holds the promise to be as effective as the standard procedure while minimizing all the related risks. It is object of the present clinical trial to randomize patients with progressive keratoconus to T-ionto CL and standard CL and compare efficacy and safety of treatments.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-04-11
• Study First Submitted QC: 2014-04-17
• Study First Posted: 2014-04-21
• Primary Completion: 2016-06
• Study Completion: 2016-09
• Results First Submitted: 2017-03-29
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-02
• Last Update Submitted: 2019-08-02
• Results First Posted: 2019-08-08
• Last Update Posted: 2019-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Diagnosis of progressive keratoconus

Exclusion Criteria

• Anterior corneal curvature steeper than 61 D;
• central corneal thickness <400 um
• corneal scarring;
• descemetocele;
• history of herpetic keratitis;
• Concomitant eye diseases;
• Inflammatory eye diseases;
• Glaucoma;
• Cataract;
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cross-linking with iontophoresis	Cross-linking with iontophoresis	Transepithelial cross-linking by using iontophoresis to administer riboflavin into the corneal stroma
Standard corneal cross-linking	Standard corneal cross-linking	Standard corneal cross-linking includes de-epithelialization and stromal soaking by applying drops of riboflavin

Primary Outcome Measures

Name	Time	Method
Corneal Endothelial Cell Density	Changes from baseline in ECD at 12 months	Endothelial cell density (ECD) will be evaluated using specular microscopy
K-max	Changes from baseline in Kmax at 12 months	Measuring maximum keratometry (K-max), measured in diopters (D), derived from computerized videokeratography.

Secondary Outcome Measures

Name	Time	Method
Optical Aberrations	Changes from baseline at 12 months.	Optical aberrations of the eye will be measured using dynamic skyascopy. Corneal wavefront aberration will be measured using Placido disk topographer and Scheimpflug tomographer.
Visual Acuity	Changes from baseline at 12 months.	Visual acuity tested using ETDRS
Contrast Sensitivity	Changes from baseline at 12 months.	Contrast sensitivity tested using Pelli-Robson chart
Central Retinal Thickness	Changes from baseline at 12 months.	Central retinal thickness (1 mm ETDRS map) will be measured before and after CXL procedures

Trial Locations

Locations (1)

Fondazione G.B. Bietti, IRCCS; 🇮🇹 Rome, Italy