Transepithelial Corneal Cross-linking Using Iontophoresis (T-iontoCL)

August 2, 2019 updated by: Marco Lombardo, Fondazione G.B. Bietti, IRCCS

Randomized Clinical Trial Comparing Transepithelial Corneal Cross-linking Using Iontophoresis and Standard Corneal Cross-linking for the Treatment of Keratoconus

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00198
        • Fondazione G.B. Bietti, IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cross-linking with iontophoresis
Transepithelial cross-linking by using iontophoresis to administer riboflavin into the corneal stroma
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.
Other Names:
  • Ricrolin+
Active Comparator: Standard corneal cross-linking
Standard corneal cross-linking includes de-epithelialization and stromal soaking by applying drops of riboflavin
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.
Other Names:
  • Ricrolin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optical Aberrations
Time Frame: 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.
Changes from baseline at 12 months.
Visual Acuity
Time Frame: Changes from baseline at 12 months.
Visual acuity tested using ETDRS
Changes from baseline at 12 months.
Contrast Sensitivity
Time Frame: Changes from baseline at 12 months.
Contrast sensitivity tested using Pelli-Robson chart
Changes from baseline at 12 months.
Central Retinal Thickness
Time Frame: Changes from baseline at 12 months.
Central retinal thickness (1 mm ETDRS map) will be measured before and after CXL procedures
Changes from baseline at 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione G.B. Bietti, IRCCS

Collaborators

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

Investigators

  • Principal Investigator: Marco Lombardo, MD, PhD, Fondazione G.B. Bietti, IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

April 11, 2014

First Submitted That Met QC Criteria

April 17, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Actual)

August 8, 2019

Last Update Submitted That Met QC Criteria

August 2, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEA27
  • PON01_00110 (Other Grant/Funding Number: PON01_00110)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

still investigating this study population up to 3 years after treatment

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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