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Completed

NCT Number: NCT02117999

Transepithelial Corneal Cross-linking Using Iontophoresis

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).

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Key information

Conditions

Progressive Keratoconus

Age range

18 year–46 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione G.B. Bietti, IRCCS

Rome, 00198, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cross-linking with iontophoresis

Device

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+

Standard corneal cross-linking

Device

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

Primary outcomes

  1. 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.

  2. Corneal Endothelial Cell Density

    Time frame: Changes from baseline in ECD at 12 months

    Endothelial cell density (ECD) will be evaluated using specular microscopy

Secondary outcomes

  1. 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.

  2. Visual Acuity

    Time frame: Changes from baseline at 12 months.

    Visual acuity tested using ETDRS

  3. Contrast Sensitivity

    Time frame: Changes from baseline at 12 months.

    Contrast sensitivity tested using Pelli-Robson chart

  4. 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

Sponsors and collaborators

Lead sponsor

Fondazione G.B. Bietti, IRCCS

Other

Collaborators

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

Registry information

Official study title

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

Acronym: T-iontoCL

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 21, 2014
Registry last updated
Aug 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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