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Ultraviolet-A and Riboflavin Treatment for Infectious Keratitis

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ClinicalTrials.gov Identifier: NCT01739673
Recruitment Status : Completed
First Posted : December 3, 2012
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
Cxlusa

Brief Summary:
This study is to evaluate the efficacy of ultraviolet-A (UVA) and riboflavin application (also often referred to as corneal collagen crosslinking) as a method to enhance treatment of infectious keratitis.

Condition or disease Intervention/treatment
Infectious Keratitis Other: Ultraviolet-A and riboflavin

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ultraviolet-A and Riboflavin Treatment for Infectious Keratitis
Study Start Date : August 2011
Primary Completion Date : July 2014
Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Riboflavin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ultraviolet-A and riboflavin Other: Ultraviolet-A and riboflavin



Primary Outcome Measures :
  1. Resolution of Signs and Symptoms of Infectious Keratitis [ Time Frame: Subjects will be followed until resolution of signs and symptoms, an expected average of 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must be 18 years of age or older.
  2. Ability to provide written informed consent.
  3. Likely to complete all study visits.
  4. Subjects must have one eye that with a diagnosis of infectious keratitis.

Exclusion Criteria:

  1. A corneal perforation.
  2. Descemetocele.
  3. Pregnancy or breastfeeding.
  4. Active Herpes corneal disease.
  5. Patient is unwilling or unable to comply with a medication regimen and follow up appointments.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01739673


Locations
United States, Arizona
Schwartz Laser Eye Center
Scottsdale, Arizona, United States
United States, California
Davidorf Eye Group
West Hills, California, United States
United States, Colorado
Corneal Consultants of Colorado, PC
Littleton, Colorado, United States
United States, Florida
Center for Excellence in Eye Care
Miami, Florida, United States
United States, Minnesota
Minnesota Eye Consultants
Minneapolis, Minnesota, United States
United States, Missouri
Ophthalmology Associates
St. Louis, Missouri, United States
Sponsors and Collaborators
Cxlusa
Investigators
Study Director: William Trattler, MD Center For Excellence In Eye Care

Responsible Party: Cxlusa
ClinicalTrials.gov Identifier: NCT01739673     History of Changes
Other Study ID Numbers: iCXL
First Posted: December 3, 2012    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: August 2015

Keywords provided by Cxlusa:
Infectious Keratitis

Additional relevant MeSH terms:
Communicable Diseases
Infection
Keratitis
Corneal Diseases
Eye Diseases
Riboflavin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents