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Cross Linking for Treatment of Corneal Infection

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ClinicalTrials.gov Identifier: NCT00912509
Recruitment Status : Terminated (insufficient efficacy)
First Posted : June 3, 2009
Results First Posted : August 22, 2014
Last Update Posted : November 22, 2017
Sponsor:
Collaborator:
Cornea Research Foundation of America
Information provided by (Responsible Party):
Price Vision Group

Study Description
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Brief Summary:
This study is comparing 45 minute and 30 minute treatment durations with the UVX corneal cross linking system to treat corneal infections.

Condition or disease Intervention/treatment Phase
Infectious Keratitis Drug: riboflavin Device: UVX Light Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Double-masked Evaluation of Treatment Duration of the UVX System for Treating Infectious Keratitis
Study Start Date : May 2009
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Riboflavin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 30 minute light duration
30 minute treatment with UVX light
 Drug: riboflavin
riboflavin 0.1% is applied every 2 minutes for 30 minutes

Device: UVX Light
UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%
Active Comparator: 45 minute light duration
45 minute treatment with UVX light
 Device: UVX Light
UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%


Outcome Measures
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Primary Outcome Measures :
  1. Time to Re-epithelialization [ Time Frame: Day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until re-epithelialization is complete ]

Secondary Outcome Measures :
  1. Time to Resolution of Stromal Infiltration [ Time Frame: day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until infiltrate is completely resolved ]

Eligibility Criteria
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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of infectious keratitis

Exclusion Criteria:

  • corneal ulcer that has perforated
  • corneal ulcer that has produced a descemetocele
  • women who are pregnant or breastfeeding
  • patients who are immunocompromised or unwilling or unable to comply with a medication regimen
Contacts and Locations
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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): NCT00912509


Locations
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United States, Indiana
Price Vision Group
Indianapolis, Indiana, United States, 46260
Sponsors and Collaborators
Price Vision Group
Cornea Research Foundation of America
Investigators
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Principal Investigator: Francis W Price, MD Price Vision Group
More Information
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Additional Information:

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Price Vision Group
ClinicalTrials.gov Identifier: NCT00912509    
Other Study ID Numbers: 2008-0143
First Posted: June 3, 2009    Key Record Dates
Results First Posted: August 22, 2014
Last Update Posted: November 22, 2017
Last Verified: October 2017
Keywords provided by Price Vision Group:
infectious keratitis
cross linking
corneal ulcer
corneal infection
collagen cross linking
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Keratitis
Corneal Diseases
Eye Diseases
Riboflavin
Vitamin B Complex
 Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents