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| Sponsors and Collaborators: |
Peschke Meditrade, GmbH Clinical Research Consultants, Inc. |
|---|---|
| Information provided by: | Peschke Meditrade, GmbH |
| ClinicalTrials.gov Identifier: | NCT00674661 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ectasia |
Procedure: Cross-linking with riboflavin/UVA light Procedure: Sham comparator |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Corneal Ectasia After Refractive Surgery |
| Estimated Enrollment: | 160 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Corneal collagen cross-linking with riboflavin and UVA light
|
Procedure: Cross-linking with riboflavin/UVA light
Cross-linking with riboflavin/UVA light
|
|
2: Sham Comparator
Riboflavin without UVA light
|
Procedure: Sham comparator
Sham treatment with riboflavin in the absence of UVA light
|
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.
Eligibility| Ages Eligible for Study: | 14 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Barbara S Fant, PharmD | 513-961-8200 | bsfant@crc-regulatory.com |
| Contact: R. Doyle Stulting, MD, PhD | 404-778-6166 | opthrds@emory.edu |
| United States, California | |
| Gordon Binder Weiss Vision Insitute | Recruiting |
| San Diego, California, United States, 92122 | |
| Contact: Perry Binder, MD 858-455-6800 | |
| Contact: Cathi Lyons 858-455-6800 clyons@gbwvision.com | |
| Principal Investigator: Perry Binder, MD | |
| United States, Florida | |
| Center for Excellence in Eye Care | Recruiting |
| Miami, Florida, United States, 33176 | |
| Contact: William Trattler, MD 305-598-2020 wtrattler@gmail.com | |
| Contact: Matty Infante 305-598-2020 mattyceec@bellsouth.net | |
| Principal Investigator: William Trattler, MD | |
| United States, Indiana | |
| Price Vision Group | Recruiting |
| Indianapolis, Indiana, United States, 46260 | |
| Contact: Marianne Price, PhD 317-814-2990 marianneprice@cornea.org | |
| Principal Investigator: Francis Price, Jr., MD | |
| United States, Kansas | |
| Durrie Vision | Recruiting |
| Overton (Kansas City), Kansas, United States, 66211 | |
| Contact: Brigette Ellis, COT 913-491-3330 ext 7255 bellis@durrievision.com | |
| Principal Investigator: Daniel S. Durrie, MD | |
| Sub-Investigator: Jason E. Stahl, MD | |
| United States, Maryland | |
| Wilmer Eye Institute at Johns Hopkins University | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Albert Jun, MD 410-502-8753 aljun@jhmi.edu | |
| Contact: Carolyn Speck 410-502-8753 cspeck@jhmi.edu | |
| Principal Investigator: Walter Stark, MD | |
| Sub-Investigator: Albert Jun, MD | |
| United States, Minnesota | |
| Minnesota Eye Consultants | Recruiting |
| Minneapolis, Minnesota, United States, 55404 | |
| Contact: Marlane Brown, OD 612-813-3621 mjbrown@mneye.com | |
| Contact: Allison Parent 952-567-6112 | |
| Principal Investigator: David Hardten, MD | |
| Sub-Investigator: Richard Lindstrom, MD | |
| United States, New Jersey | |
| Cornea & Laser Eye Institute; Hersh Vision Group | Recruiting |
| Teaneck, New Jersey, United States, 07666 | |
| Contact: Kristen Fry, OD 201-692-9434 KFry@vision-institute.com | |
| Principal Investigator: Peter Hersh, MD | |
| United States, New York | |
| Ophthalmic Consultants of Long Island | Recruiting |
| Rockville Centre, New York, United States, 11570 | |
| Contact: Anne Bjornson, COT 516-766-2519 ext 148 abjornson@ocli.net | |
| Principal Investigator: Eric Donnenfeld, MD | |
| Sub-Investigator: Marguerite McDonald, MD | |
| Edward Harkness Eye Institute at Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Elona Gavazi 212-305-5922 EG2119@columbia.edu | |
| Contact: William Kim 212-305-5067 billkim@columbia.edu | |
| Principal Investigator: Stephen Trokel, MD | |
| Sub-Investigator: Richard Braunstein, MD | |
| Sub-Investigator: Amelia Schrier, MD | |
| Study Director: | R. Doyle Stulting, MD, PhD | Emory University |
More Information
| Responsible Party: | Emory University ( Study Director: R. Doyle Stulting, MD, PhD ) |
| Study ID Numbers: | UVX-003 |
| Study First Received: | May 6, 2008 |
| Last Updated: | November 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00674661 |
| Health Authority: | United States: Food and Drug Administration |
|
ectasia cross-linking crosslinking |
cornea riboflavin UVA |
|
Pathological Conditions, Anatomical Corneal Diseases Riboflavin Dilatation, Pathologic |
|
Photosensitizing Agents Vitamin B Complex Radiation-Sensitizing Agents Growth Substances Vitamins |
Therapeutic Uses Physiological Effects of Drugs Micronutrients Dermatologic Agents Pharmacologic Actions |
