Transepithelial Corneal Cross-linking Using Iontophoresis

Status Completed

Clinical Trial 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).

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02117999
Study type	Interventional
Source	Fondazione G.B. Bietti, IRCCS
Contact
Status	Completed
Phase	N/A
Start date	January 2014
Completion date	September 2016

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02721628` - Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus	N/A
Completed	`NCT02883868` - Stromal Demarcation Line: is it Predictive for Cross-Linking Efficiency?	N/A
Active, not recruiting	`NCT04427956` - Corneal Crosslinking Treatment Study	Phase 4
Terminated	`NCT01868620` - Non-inferiority Trial of Iontophoretic Corneal Collagen Crosslinking (CXL) Compared to Standard Corneal Collagen Crosslinking in Progressive Keratoconus.	N/A
Recruiting	`NCT05314738` - Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus	Phase 1/Phase 2
Not yet recruiting	`NCT06450470` - Use of a Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus	Phase 3
Completed	`NCT01485211` - Corneal Thickness Changes During Corneal Collagen Cross-linking With Ultraviolet-A Irradiation and Riboflavin	Phase 4
Completed	`NCT04504578` - Efficacy and Safety ofCACXL in the Treatment of Keratoconus With Thin Corneas	N/A
Completed	`NCT00647699` - Corneal Collagen Cross-linking for Progressive Keratoconus	Phase 3
Completed	`NCT00567671` - Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia	Phase 2/Phase 3
Recruiting	`NCT00815256` - Safety and Effectiveness of Collagen Cross Linking in Progressive Mild and Moderate Keratoconus	Phase 3
Recruiting	`NCT04045626` - Study of Demarcation Line Depth in Transepithelial Versus Epithelium-off Accelerated Cross-linking (AXL) in Keratocouns	N/A
Completed	`NCT03442751` - Study to Evaluate the Safety and Efficacy of Epi-on Corneal Cross-linking in Eyes With Progressive Keratoconus	Phase 3
Withdrawn	`NCT00679666` - Corneal Crosslinking in Keratoconus and Corneal Ectasia	Phase 2/Phase 3
Completed	`NCT01411384` - Evaluation of Corneal Hysteresis and Corneal Resistance Factor After Corneal Cross-linking for Keratoconus	N/A
Not yet recruiting	`NCT00925327` - Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking for Compassionate Treatment in Pediatric Patients With Progressive Keratoconus	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Transepithelial Corneal Cross-linking Using Iontophoresis — T-iontoCL

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms