Ultraviolet-A and Riboflavin Treatment for Infectious Keratitis

September 24, 2018 updated by: Cxlusa
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States
        • Schwartz Laser Eye Center
    • California
      • West Hills, California, United States
        • Davidorf Eye Group
    • Colorado
      • Littleton, Colorado, United States
        • Corneal Consultants of Colorado, PC
    • Florida
      • Miami, Florida, United States
        • Center for Excellence in Eye Care
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Minnesota Eye Consultants
    • Missouri
      • Saint Louis, Missouri, United States
        • Ophthalmology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultraviolet-A and riboflavin
Other: Ultraviolet-A and riboflavin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Subjects will be followed until resolution of signs and symptoms, an expected average of 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cxlusa

Investigators

  • Study Director: William Trattler, MD, Center for Excellence in Eye Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

November 27, 2012

First Submitted That Met QC Criteria

November 30, 2012

First Posted (Estimate)

December 3, 2012

Study Record Updates

Last Update Posted (Actual)

September 26, 2018

Last Update Submitted That Met QC Criteria

September 24, 2018

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iCXL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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