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Clinical Trials of Corneal Collagen Crosslinking (CXL) for Keratoconus and Ectasia Now Available
We are pleased to announce that we are conducting 3 clinical trials of corneal collagen crosslinking (CXL). The clinical trials are designed to study the benefits and safety of corneal collagen crosslinking in patients with either keratoconus or corneal ectasia after previous refractive surgery.
We have been participating in CXL treatments in formal clinical trials for four years and have performed more than 300 procedures to date. See www.clinicaltrials.gov for general information regarding clinical trials and see CXL and CXL/Intacs and Transepithelial CXL for specific information on the crosslinking studies available at the CLEI Center for Keratoconus.
CLINICAL TRIAL OF TRANSEPITHELIAL (EPI-ON) CORNEAL COLLAGEN CROSSLINKING
Dr. Hersh and the CLEI Center for Keratoconus are pleased to announce a new clinical trial of transepithelial corneal collagen crosslinking (CXL) for keratoconus and corneal ectasia after previous surgery. Transepithelial crosslinking is sometimes known as the "epi-on" crosslinking technique. This study compares two variants of transepithelial crosslinking. All subjects will undergo pre-treatment with a topical anesthetic (to improve riboflavin absorption) and riboflavin 0.1% for 60 minutes or more. During UV light application, patients will receive one of two treatments - administration of riboflavin every 1 minute with UV light or administration of riboflavin every 2 minutes with UV light. The primary goal is to evaluate efficacy of the two transepithelial procedures. The second goal is to determine if there is equivalency between groups. Transepithelial crosslinking, in which the epithelium is not removed, has been proposed to offer a number of advantages over traditional crosslinking including an increased safety profile by reducing the risk of infection as no epithelial barrier will be broken, faster visual recover, and improved patient comfort in the early postoperative healing period since re-epithelialization is not required.
CLINICAL TRIAL OF CORNEAL COLLAGEN CROSSLINKING AND INTACS FOR KERATOCONUS AND ECTASIA
Dr. Hersh and the CLEI Center for Keratoconus are currently enrolling patients in a clinical study looking at the use of combined Intacs and corneal collagen crosslinking (CXL) in patients with either keratoconus or corneal ectasia after previous refractive surgery. The clinical trials will evaluate the benefits and safety of a combined Intacs and CXL procedure. The second objective of the study is to compare timing of the 2 interventions on clinical outcomes.
For further information and inquiries, call 201-883-0505 or email info@vision-institute.com.
For further qualifications and information, please click below:
CLINICAL TRIAL OF CORNEAL COLLAGEN CROSSLINKING FOR PROGRESSIVE KERATOCONUS AND ECTASIA
Dr. Hersh and the CLEI Center for Keratoconus are currently enrolling patients in a clinical trial of corneal collagen crosslinking (CXL) for keratoconus and corneal ectasia after previous refractive surgery. The objective of this study is to
investigate any difference between 2 riboflavin preparations during UV administration. The first
preparation contains riboflavin in a dextran solution, which may tend to draw water out of the
cornea and keep it thinner. The second preparation contains riboflavin in a hypotonic (low salt)
solution without dextran, which may tend to keep the cornea more swollen. The primary goal of
the study is to see if the use of hypotonic riboflavin (rather than riboflavin with dextran) better
maintains consistent corneal thickness during UV administration. The second goal of the study
is to determine if better maintenance of corneal thickness potentially could have benefits of
better consistency of the procedure, decrease in corneal haze formation, and improved safety of
the endothelial cells.
For further information about the trial call 201-883-0505 or email info@vision-institute.com.
For further qualifications, please click below:
Qualifications
CORNEAL COLLAGEN CROSSLINKING (CXL) BACKGROUND
Collagen crosslinking using UV radiation combined with riboflavin (Vitamin B2) is an experimental procedure currently being performed in Europe and elsewhere outside the United States. It is not approved for general clinical use in the United States. However, here at the CLEI Center for Keratoconus, we are participating in a formal study of CXL using the UV-UVX Illumination System that is being conducted under FDA guidelines. We began actively treating patients in February, 2008 and have performed over 200 procedures to date. The goal of our studies is to assess the safety and efficacy of crosslinking for the treatment of keratoconus as well as corneal ectasia after LASIK.
The primary goal of collagen crosslinking in the keratoconic patient is to strengthen and stiffen the corneal fibers in order to decrease the progression of keratoconus, and to decrease the cone steepness in some patients. The safety and efficacy of crosslinking, as yet, is unclear, although results from European and other international studies are encouraging.
THE CROSSLINKING PROCEDURE
Anesthesia drops keep you comfortable and a lid retainer prevents you from blinking. The surface epithelial cells of the cornea are then removed, except in the transepithelial procedure, and riboflavin drops are administered for 30 minutes. The riboflavin acts both to enhance the crosslinking effect and to protect the rest of the eye from the UV exposure.
The patient then looks at a UV emitting light (wavelength = 365 microns, power = 3.0 mW/cm2) for 30 additional minutes with continued administration of riboflavin drops. At the conclusion of the procedure, a soft contact lens bandage generally is applied. The contact lens is left in place to improve healing for approximately 5 days and is then removed. Antibiotic and anti-inflammatory drops are used for two weeks afterwards.
Here at the CLEI Center for Keratoconus, we have treated approximately 200 patients with CXL in our clinical trial program over the past 4 years. Analysis of results of safety and efficacy of the procedure is currently underway.
In the News:
Dr. Hersh discusses Corneal Collagen Crosslinking for Keratoconus on NJN News
Crosslinking Technology for Keratoconus Yields Positive Early Results - December 18, 2009
Corneal Collagen Crosslinking Articles from Peter Hersh, M.D. -
ONE YEAR RESULTS - CORNEAL COLLAGEN CROSSLINKING FOR KERATOCONUS AND CORNEAL ECTASIA
NEW STUDY RESULTS JUST PUBLISHED BY DR. HERSH AND CLEI CENTER FOR KERATOCONUS: COLLAGEN CROSSLINKING - ASSOCIATED CORNEAL HAZE
This study looks at the healing course after corneal crosslinking and helps doctors understand what to look for at different timepoints in their CXL patients.
CORNEAL TOPOGRAPHY INDICES AFTER CORNEAL COLLAGEN CROSSLINKING FOR KERATOCONUS AND CORNEAL ECTASIA
CORNEAL THICKNESS CHANGES AFTER CORNEAL COLLAGEN CROSSLINKING FOR KERATOCONUS AND CORNEAL ECTASIA
