Transepithelial Corneal Cross-linking Using Iontophoresis

NCT02117999 | Completed Results

• 2 other identifiers: SEA27PON01_00110
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Progressive Keratoconus

Keywords

corneal cross-linking; transepithelial corneal cross-linking; iontophoresis; progressive keratoconus

Outcome Measures

Primary Outcomes (2)

• K-max

  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

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

  Changes from baseline in ECD at 12 months

Secondary Outcomes (4)

• Optical Aberrations

  Changes from baseline at 12 months.

• Visual Acuity

  Changes from baseline at 12 months.

• Contrast Sensitivity

  Changes from baseline at 12 months.

• Central Retinal Thickness

  Changes from baseline at 12 months.

Study Arms (2)

Cross-linking with iontophoresis

EXPERIMENTAL

Transepithelial cross-linking by using iontophoresis to administer riboflavin into the corneal stroma

Device: Cross-linking with iontophoresis

Standard corneal cross-linking

ACTIVE COMPARATOR

Standard corneal cross-linking includes de-epithelialization and stromal soaking by applying drops of riboflavin

Device: Standard corneal cross-linking

Interventions

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.

Also known as: Ricrolin+

Cross-linking with iontophoresis

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.

Also known as: Ricrolin

Standard corneal cross-linking

Eligibility Criteria

• Age: 18 Years - 46 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of progressive keratoconus

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione G.B. Bietti, IRCCS: lead
• CNR Institute for chemical and physical processes (IPCF), Messina: collaborator

Study Sites (1)

Fondazione G.B. Bietti, IRCCS

Rome, 00198, Italy

Location

Related Publications (7)

• Spoerl E, Huhle M, Seiler T. Induction of cross-links in corneal tissue. Exp Eye Res. 1998 Jan;66(1):97-103. doi: 10.1006/exer.1997.0410.

  PMID: 9533835 BACKGROUND

• Hao J, Li SK, Liu CY, Kao WW. Electrically assisted delivery of macromolecules into the corneal epithelium. Exp Eye Res. 2009 Dec;89(6):934-41. doi: 10.1016/j.exer.2009.08.001. Epub 2009 Aug 12.

  PMID: 19682448 BACKGROUND

• Eljarrat-Binstock E, Domb AJ. Iontophoresis: a non-invasive ocular drug delivery. J Control Release. 2006 Feb 21;110(3):479-89. doi: 10.1016/j.jconrel.2005.09.049. Epub 2005 Dec 15.

  PMID: 16343678 BACKGROUND

• Bikbova G, Bikbov M. Transepithelial corneal collagen cross-linking by iontophoresis of riboflavin. Acta Ophthalmol. 2014 Feb;92(1):e30-4. doi: 10.1111/aos.12235. Epub 2013 Jul 15.

  PMID: 23848196 BACKGROUND

• Meek KM, Hayes S. Corneal cross-linking--a review. Ophthalmic Physiol Opt. 2013 Mar;33(2):78-93. doi: 10.1111/opo.12032.

  PMID: 23406488 BACKGROUND

• Lombardo M, Serrao S, Lombardo G, Schiano-Lomoriello D. Two-year outcomes of a randomized controlled trial of transepithelial corneal crosslinking with iontophoresis for keratoconus. J Cataract Refract Surg. 2019 Jul;45(7):992-1000. doi: 10.1016/j.jcrs.2019.01.026. Epub 2019 Apr 16.

  PMID: 31003798 DERIVED

• Lombardo M, Giannini D, Lombardo G, Serrao S. Randomized Controlled Trial Comparing Transepithelial Corneal Cross-linking Using Iontophoresis with the Dresden Protocol in Progressive Keratoconus. Ophthalmology. 2017 Jun;124(6):804-812. doi: 10.1016/j.ophtha.2017.01.040. Epub 2017 Mar 7.

  PMID: 28283279 DERIVED

Related Links

• Inclusion and exclusion criteria to the present RCT are shown in the main website page

MeSH Terms

Interventions

Iontophoresis

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Electrophoresis; Electrochemical Techniques; Investigative Techniques

Limitations and Caveats

Principal Investigator (PI) is NOT employed by the organization sponsoring the study. There is NOT an agreement between the PI and the Sponsor that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Title: Marco Lombardo
• Organization: Studio Italiano di Oftalmologia

mlombardo@visioeng.it

+39 331 34 38 300

Study Officials

• Marco Lombardo, MD, PhD

  Fondazione G.B. Bietti, IRCCS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Marco Lombardo

Model Details: Consecutive patients were randomized, using block randomization model, in one of the arm

Study Record Dates

• First Submitted: April 11, 2014
• First Posted: April 21, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: August 8, 2019
• Results First Posted: August 8, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)