Corneal Crosslinking Treatment Study

Status Active, not recruiting

Clinical Trial Summary

Three different protocols for inducing corneal crosslinks in subjets with progressive keratoconus will be evaluated in this randomised clinical study.

Clinical Trial Description

Riboflavin does not penetrate the intact corneal epithelium. Corneal cross linking (CXL) is typically performed using the so-called "Dresden protocol". The Dresden protocol states 30 minutes of UVA-radiation (3mW/cm2) but a 10 minute irradiation protocol (9mW/cm2) is frequently used. Both of the protocols involve mechanical removal of the epithelium over the central 8 mm of the corneal surface. The first days after treatment therefore involves some degree of pain, often intense, and the presence of a healing epithelial defect may be associated with development of infiltrates in the cornea. A number of approaches have been evaluated in order to promote riboflavin penetration through the intact epithelium, of which iontophoresis appears most promising. Keratoconic corneas are thin at the cone location and sometimes it is difficult to maintain the safety margin of 400 microns during corneal crosslinking. Instead of using isotonic standard riboflavin, a swelling effect of the cornea can be obtained by using hypotonic riboflavin. However, the latter has been indicated as less effective in the process of inducing cross links. Eighty-one of 81 patients of various degrees of keratoconus will be randomised to one of the following groups: 1) CXL (UVA 9mW/cm2) using isotonic riboflavin, or 2) CXL (UVA 9mW/cm2) using hypotonic riboflavin or 3) Iontophoresis with Ricrolin with following CXL (UVA 9mW/cm2). Hypothesis: i) CXL with hypotonic riboflavin or CXL with Ricrolin administered by iontophoresis or CXL with isotonic riboflavin is non-inferior compared to standard CXL with isotonic riboflavin. ii) The morphological structure post-CXL in the three different groups will be similar without any significant differences. The iontophoresis-assisted treatment arm has been interrupted due to low efficacy in halting disease progression. The results have been published. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04427956
Study type	Interventional
Source	Region Skane
Contact
Status	Active, not recruiting
Phase	Phase 4
Start date	May 23, 2017
Completion date	November 1, 2024

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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
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
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
Completed	`NCT01411384` - Evaluation of Corneal Hysteresis and Corneal Resistance Factor After Corneal Cross-linking for Keratoconus	N/A
Withdrawn	`NCT00679666` - Corneal Crosslinking in Keratoconus and Corneal Ectasia	Phase 2/Phase 3
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.