Trial | NCT00912509  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Intervention/Treatment

    riboflavin ...

  • Study Participants

    30
This study is comparing 45 minute and 30 minute treatment durations with the UVX corneal cross linking system to treat corneal infections.
Study Started
May 31
2009
Primary Completion
Jun 30
2013
Study Completion
Jun 30
2013
Results Posted
Aug 22
2014
Estimate
Last Update
Nov 22
2017

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%

30 minute light duration Active Comparator

30 minute treatment with UVX light

45 minute light duration Active Comparator

45 minute treatment with UVX light

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

Summary

30 Minute Light Duration

45 Minute Light Duration

All Events

Event Type Organ System Event Term 30 Minute Light Duration 45 Minute Light Duration

Time to Re-epithelialization

30 Minute Light Duration

14.0
Days (Median)
Inter-Quartile Range: 6.0 to 28.0

45 Minute Light Duration

11.0
Days (Median)
Inter-Quartile Range: 6.0 to 29.0

Time to Resolution of Stromal Infiltration

30 Minute Light Duration

21.0
days (Median)
Inter-Quartile Range: 8.0 to 33.0

45 Minute Light Duration

10.0
days (Median)
Inter-Quartile Range: 7.0 to 11.0

Total

30
Participants

Age, Categorical

Sex: Female, Male

Overall Study

30 Minute Light Duration

45 Minute Light Duration

Drop/Withdrawal Reasons

30 Minute Light Duration

45 Minute Light Duration