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Cross Linking for Treatment of Corneal Infection
This study has been terminated.
(insufficient efficacy)
Sponsor:
Price Vision Group
Collaborator:
Cornea Research Foundation of America
Information provided by (Responsible Party):
Price Vision Group
ClinicalTrials.gov Identifier:
NCT00912509
First received: May 30, 2009
Last updated: August 21, 2014
Last verified: August 2014
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Purpose
This study is comparing 45 minute and 30 minute treatment durations with the UVX corneal cross linking system to treat corneal infections.
| Condition | Intervention |
|---|---|
| Infectious Keratitis | Drug: riboflavin Device: UVX Light |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
keratitis-ichthyosis-deafness syndrome
Drug Information available for:
Riboflavin
U.S. FDA Resources
Further study details as provided by Price Vision Group:
Primary Outcome Measures:
- Time to Re-epithelialization [ Time Frame: Day 1, Day 2, Day 3, (daily assessment) after study treatment until re-epithelialization is complete ]
Secondary Outcome Measures:
- Time to Resolution of Stromal Infiltration [ Time Frame: day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, week 3 (weekly assessment) until infiltrate is completely resolved ]
| Enrollment: | 30 |
| Study Start Date: | May 2009 |
| Study Completion Date: | June 2013 |
| Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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%
|
Eligibility| Ages Eligible for Study: | 14 Years and older (Child, Adult, Senior) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00912509
Please refer to this study by its ClinicalTrials.gov identifier: NCT00912509
Locations
| United States, Indiana | |
| Price Vision Group | |
| Indianapolis, Indiana, United States, 46260 | |
Sponsors and Collaborators
Price Vision Group
Cornea Research Foundation of America
Investigators
| Principal Investigator: | Francis W Price, MD | Price Vision Group |
More Information
Additional Information:
Publications:
| Responsible Party: | Price Vision Group |
| ClinicalTrials.gov Identifier: | NCT00912509 History of Changes |
| Other Study ID Numbers: |
2008-0143 |
| Study First Received: | May 30, 2009 |
| Results First Received: | August 4, 2014 |
| Last Updated: | August 21, 2014 |
Keywords provided by Price Vision Group:
|
infectious keratitis cross linking corneal ulcer corneal infection collagen cross linking |
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 |
ClinicalTrials.gov processed this record on September 21, 2017