Back to resultsCollagen Cross-linking in Infectious Keratitis Trial
Primary Purpose
Infectious Keratitis, Bacterial Keratitis, Fungal Keratitis
Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Collagen cross-linking
Sponsored by
About this trial
This is an interventional treatment trial for Infectious Keratitis focused on measuring corneal ulcer, keratitis
Eligibility Criteria
Inclusion Criteria:
- Evidence of corneal ulcer grade II or III (bacteria or fungal, or presumed bacterial or fungal)
- Age more than 6 year
- Patients can understand and can follow the study protocol
Exclusion Criteria:
- Pregnancy by history or urine test
- Evidence of herpetic keratitis
- Evidence of corneal perforation
- Evidence of autoimmune disease
- Known allergy to study medication
Sites / Locations
- Ophthalmology department, King Chulalongkorn Memorial hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Collagen cross-linking
standard treatment
Arm Description
Collagen cross-linking with standard treatment
Standard treatment alone
Outcomes
Primary Outcome Measures
decrement of infiltration size
decrement of infiltration size between day0 and day 30
Secondary Outcome Measures
number of participants with adverse events
adverse events after corneal collagen cross-linking (report in descriptive study)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01831206
Brief Title
Collagen Cross-linking in Infectious Keratitis Trial
Official Title
Collagen Cross-linking in Infectious Keratitis Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of collagen cross-linking for treatment of infectious keratitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Keratitis, Bacterial Keratitis, Fungal Keratitis
Keywords
corneal ulcer, keratitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Collagen cross-linking
Arm Type
Experimental
Arm Description
Collagen cross-linking with standard treatment
Arm Title
standard treatment
Arm Type
No Intervention
Arm Description
Standard treatment alone
Intervention Type
Procedure
Intervention Name(s)
Collagen cross-linking
Intervention Description
Collagen cross-linking arm will receive standard medication for corneal ulcer treatment and corneal collagen cross-linking.
Standard treatment arm will receive only standard medication.
Primary Outcome Measure Information:
Title
decrement of infiltration size
Description
decrement of infiltration size between day0 and day 30
Time Frame
1 months
Secondary Outcome Measure Information:
Title
number of participants with adverse events
Description
adverse events after corneal collagen cross-linking (report in descriptive study)
Time Frame
1 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Evidence of corneal ulcer grade II or III (bacteria or fungal, or presumed bacterial or fungal)
Age more than 6 year
Patients can understand and can follow the study protocol
Exclusion Criteria:
Pregnancy by history or urine test
Evidence of herpetic keratitis
Evidence of corneal perforation
Evidence of autoimmune disease
Known allergy to study medication
Facility Information:
Facility Name
Ophthalmology department, King Chulalongkorn Memorial hospital
City
Pratumwan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand
12. IPD Sharing Statement
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
Collagen Cross-linking in Infectious Keratitis Trial
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