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Corneal Collagen Cross-Linking for Ectasia (CXL)

18:19 EDT 24th April 2014 | BioPortfolio

Summary

Prospective, randomized multicenter study to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes with ectasia after refractive surgery.

Description

Subjects are randomized to a control group or a treatment group, with the control group crossed over to the treatment group at the 3 month visit. Fellow eyes may be treated at 3 months or later. Corneal collagen cross-linking is performed as a single treatment. Subjects are followed for 12 months after the procedure to evaluate the long term effects of corneal collagen cross-linking.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Ectasia

Intervention

Cross-linking with riboflavin/UVA light, Sham comparator

Location

Gordon Binder Weiss Vision Insitute
San Diego
California
United States
92122

Status

Active, not recruiting

Source

Avedro, Inc.

Results (where available)

View Results

Links

Medical and Biotech [MESH] Definitions

An enzyme that catalyzes the formation of riboflavin from two molecules of 6,7-dimethyl-8-ribityllumazine, utilizing a four-carbon fragment from one molecule which is transferred to the second molecule. EC 2.5.1.9.

Enzyme which catalyzes the peptide cross-linking of nascent CELL WALL; PEPTIDOGLYCAN.

One of the protein CROSS-LINKING REAGENTS that is used as a disinfectant for sterilization of heat-sensitive equipment and as a laboratory reagent, especially as a fixative.

A naturally occurring furocoumarin, found in PSORALEA. After photoactivation with UV radiation, it binds DNA via single and double-stranded cross-linking.

An antineoplastic antibiotic produced by Streptomyces caespitosus. It is one of the bi- or tri-functional ALKYLATING AGENTS causing cross-linking of DNA and inhibition of DNA synthesis.

Clinical Trials [509 Associated Clinical Trials listed on BioPortfolio]

Riboflavin-UVA Induced Collagen Crosslinking Treatment for Corneal Ectasia

This is a hospital-based interventional prospective study. Patients with clinical keratoconus or LASIK keratectasia presenting to the Singapore National Eye Centre who meet the eligibility...

Corneal Collagen Cross-linking With Hypotonic Riboflavin in Corneas Thinner Than 400 Microns

Corneal ectasia is a relative weakness in the structure of the cornea, which produces a progressive change in its shape which results in visual distortion. It is known that collagen cross...

Corneal Crosslinking in Keratoconus and Corneal Ectasia

Prospective, randomized, single site to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes progressive keratoc...

Collagen Cross-Linking for Keratoconus/Ectasia With and Without Intacs

This study will determine the efficacy of collagen cross linking for progressive keratoconus and ectasia after lasik. It will try and determine which is a more effective treatment: collage...

Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking for Compassionate Treatment in Pediatric Patients With Progressive Keratoconus

This is a compassionate treatment protocol for the use of the UV-X system for corneal collagen cross-linking (CXL) in eyes with progressive keratoconus in patients who have conditions that...

PubMed Articles [7377 Associated PubMed Articles listed on BioPortfolio]

Topographic corneal changes after collagen cross-linking in patients with corneal keratoconus.

Corneal collagen cross-linking with riboflavin, also known as collagen cross-linking (CXL), involves the application of riboflavin solution to the eye that is activated by illumination with ultraviole...

Impact of fluorescein on the antimicrobial efficacy of photoactivated riboflavin in corneal collagen cross-linking.

To investigate the effect of fluorescein on the antimicrobial efficacy of photoactivated riboflavin in corneal collagen cross-linking (CXL) in vitro.

The Biomechanical Effect of Corneal Collagen Cross-Linking (CXL) With Riboflavin and UV-A is Oxygen Dependent.

In an attempt to reduce treatment time in corneal collagen cross-linking (CXL) with riboflavin and ultraviolet-A (UV-A), recent protocol modifications include shorter irradiation times at higher fluen...

Corneal collagen cross-linking in the treatment of progressive keratoconus-preliminary results.

To evaluate the efficacy and safety of riboflavin-ultraviolet-A (UV-A)-induced corneal collagen cross-linking (CXL) in the management of progressive keratoconus.

Distribution of Young's Modulus in Porcine Corneas after Riboflavin/UVA-Induced Collagen Cross-Linking as Measured by Atomic Force Microscopy.

Riboflavin/UVA-induced corneal collagen cross-linking has become an effective clinical application to treat keratoconus and other ectatic disorders of the cornea. Its beneficial effects are attributed...

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