Non-inferiority Trial of Iontophoretic Corneal Collagen Crosslinking (CXL)

Status Terminated

Clinical Trial Summary

The primary purpose of the protocol is to compare the current standard CXL with iontophoretic CXL to provide evidence in relation to the efficacy and safety in progressive keratoconus.

Corneal collagen crosslinking (CXL) is the first surgical procedure that appears to halt the progression of keratoconus. In the current standard CXL, the central corneal epithelium must be debrided to efficiently permeate the corneal stroma with riboflavin. The epithelium debridement can cause severe pain, infection and stromal haze. The study hypothesis is that iontophorese CXL is as effective as standard CXL to stabilize a progressive keratoconus.

Clinical Trial Description

Keratoconus is a common bilateral progressive corneal ecstatic disease causing visual impairment by inducing irregular astigmatism and corneal opacities. This disorder typically begins during teenage years, progresses until the age of 30 to 40 years and, in severe forms, may need a corneal transplantation. CXL has changed the natural evolution of keratoconus. It creates links between collagen fibrils in order to rigidify the corneal stroma and slow down the progression of keratoconus. The corneal stroma is soaked with a riboflavin solution before being exposed to ultraviolet-A radiation.

In the current standard CXL, the central corneal epithelium must be debrided to allow the penetration of riboflavin into the cornea with 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 riboflavin into the cornea. The iontophoresis technique could allow intrastromal riboflavin diffusion, while keeping the corneal epithelium on, combining the efficiency of the standard procedure without the side effects of epithelial debridement. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01868620
Study type	Interventional
Source	University Hospital, Toulouse
Contact
Status	Terminated
Phase	N/A
Start date	May 2013
Completion date	March 2017

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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
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	`NCT02117999` - Transepithelial Corneal Cross-linking Using Iontophoresis	N/A
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	`NCT00567671` - Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia	Phase 2/Phase 3
Completed	`NCT00647699` - Corneal Collagen Cross-linking for Progressive Keratoconus	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.

Non-inferiority Trial of Iontophoretic Corneal Collagen Crosslinking (CXL) Compared to Standard Corneal Collagen Crosslinking in Progressive Keratoconus. — IONTO-CXL

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms