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Ultraviolet-A and Riboflavin Treatment for Infectious Keratitis

Primary Purpose

Infectious Keratitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultraviolet-A and riboflavin
Sponsored by
Cxlusa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infectious Keratitis focused on measuring Infectious Keratitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Schwartz Laser Eye Center
  • Davidorf Eye Group
  • Corneal Consultants of Colorado, PC
  • Center for Excellence in Eye Care
  • Minnesota Eye Consultants
  • Ophthalmology Associates

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ultraviolet-A and riboflavin

Arm Description

Outcomes

Primary Outcome Measures

Resolution of Signs and Symptoms of Infectious Keratitis

Secondary Outcome Measures

Full Information

First Posted
November 27, 2012
Last Updated
September 24, 2018
Sponsor
Cxlusa
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1. Study Identification

Unique Protocol Identification Number
NCT01739673
Brief Title
Ultraviolet-A and Riboflavin Treatment for Infectious Keratitis
Official Title
Ultraviolet-A and Riboflavin Treatment for Infectious Keratitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cxlusa

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Keratitis
Keywords
Infectious Keratitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultraviolet-A and riboflavin
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Ultraviolet-A and riboflavin
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must be 18 years of age or older. Ability to provide written informed consent. Likely to complete all study visits. Subjects must have one eye that with a diagnosis of infectious keratitis. Exclusion Criteria: A corneal perforation. Descemetocele. Pregnancy or breastfeeding. Active Herpes corneal disease. Patient is unwilling or unable to comply with a medication regimen and follow up appointments.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Trattler, MD
Organizational Affiliation
Center For Excellence In Eye Care
Official's Role
Study Director
Facility Information:
Facility Name
Schwartz Laser Eye Center
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Davidorf Eye Group
City
West Hills
State/Province
California
Country
United States
Facility Name
Corneal Consultants of Colorado, PC
City
Littleton
State/Province
Colorado
Country
United States
Facility Name
Center for Excellence in Eye Care
City
Miami
State/Province
Florida
Country
United States
Facility Name
Minnesota Eye Consultants
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Ophthalmology Associates
City
Saint Louis
State/Province
Missouri
Country
United States

12. IPD Sharing Statement

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Ultraviolet-A and Riboflavin Treatment for Infectious Keratitis

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