Cross Linking for Treatment of Corneal Infection

Infectious Keratitis Clinical Trial

Official title:

A Prospective Randomized Double-masked Evaluation of Treatment Duration of the UVX System for Treating Infectious Keratitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00912509
• Other study ID #: 2008-0143
• Status: Terminated
• Phase: N/A
• First received: May 30, 2009
• Last updated: October 19, 2017
• Start date: May 2009
• Est. completion date: June 2013

Study information

• Verified date: October 2017
• Source: Price Vision Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infectious Keratitis
• Keratitis

Intervention

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%

Locations

Country	Name	City	State
United States	Price Vision Group	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Price Vision Group	Cornea Research Foundation of America

Country where clinical trial is conducted

United States, 

References & Publications (2)

Iseli HP, Thiel MA, Hafezi F, Kampmeier J, Seiler T. Ultraviolet A/riboflavin corneal cross-linking for infectious keratitis associated with corneal melts. Cornea. 2008 Jun;27(5):590-4. doi: 10.1097/ICO.0b013e318169d698. — View Citation

Price MO, Tenkman LR, Schrier A, Fairchild KM, Trokel SL, Price FW Jr. Photoactivated riboflavin treatment of infectious keratitis using collagen cross-linking technology. J Refract Surg. 2012 Oct;28(10):706-13. doi: 10.3928/1081597X-20120921-06. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Re-epithelialization		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	Time to Resolution of Stromal Infiltration		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

External Links

•   Price Vision Group website