Back to resultsUVX as an Adjuvant in the Treatment of Fungal Keratitis
Primary Purpose
Treatment
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
topical voriconazole / levofloxacin systemic itraconazole
CXL
Sponsored by
About this trial
This is an interventional treatment trial for Treatment
Eligibility Criteria
Inclusion Criteria:
- fungal keratitis documented by culture or confocal scanning without any previous treatment
Exclusion Criteria:
- Previous treatment
- Thinning at presentation
- Perforation
- Associated with other microbial or viral keratitis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
conventional treatment
conventional treatment +CXL
Arm Description
In this arm, patients with documented fungal keratitis undergo conventional medical treatment.
In this arm, patients with documented fungal keratitis undergo conventional medical treatment plus CXL, beginning on the first day
Outcomes
Primary Outcome Measures
time of complete healing (days)
time to scar formation (days)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03138785
Brief Title
UVX as an Adjuvant in the Treatment of Fungal Keratitis
Official Title
UVX as an Adjuvant in the Treatment of Fungal Keratitis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
June 1, 2017 (Anticipated)
Study Completion Date
July 1, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Farabi Eye Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this study, investigators want to find the effect of adjuvant collagen cross-linking in the treatment of fungal keratitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conventional treatment
Arm Type
Experimental
Arm Description
In this arm, patients with documented fungal keratitis undergo conventional medical treatment.
Arm Title
conventional treatment +CXL
Arm Type
Active Comparator
Arm Description
In this arm, patients with documented fungal keratitis undergo conventional medical treatment plus CXL, beginning on the first day
Intervention Type
Drug
Intervention Name(s)
topical voriconazole / levofloxacin systemic itraconazole
Intervention Description
starting topical voriconazole every hour tapering after 4 days , levofloxacin every 6 hours, Itraconazole 100mg /BD for 2 weeks
Intervention Type
Radiation
Intervention Name(s)
CXL
Other Intervention Name(s)
Collagen cross-linking/ UVx
Intervention Description
30 min Riboflavin prescription to the cornea followed by 30 min UV-A radiation at 3mW/cm2 associated with Riboflavin administration
Primary Outcome Measure Information:
Title
time of complete healing (days)
Description
time to scar formation (days)
Time Frame
180 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
fungal keratitis documented by culture or confocal scanning without any previous treatment
Exclusion Criteria:
Previous treatment
Thinning at presentation
Perforation
Associated with other microbial or viral keratitis
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32557558
Citation
Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.
Results Reference
derived
Learn more about this trial
UVX as an Adjuvant in the Treatment of Fungal Keratitis
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