Back to resultsCross-linking as Treatment in Infectious Keratitis
Primary Purpose
Infectious Keratitis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
PACK-CXL
Sponsored by
About this trial
This is an interventional treatment trial for Infectious Keratitis
Eligibility Criteria
Inclusion Criteria:
- Fungal infectious keratitis
- bacterial infectious keratitis
- Must be not responding to medication
Exclusion Criteria:
- Viral keratitis
- Pregnancy and lactation
Sites / Locations
- Faculty of medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Standard CXL
Accelerated CXL
Arm Description
Standard epithelium-off CXL, 30 minutes soaking time with riboflavin, 30 minutes UVA corneal irradiation continuous mode.
Accelerated epithelium-off CXL, 12 minutes soaking time with riboflavin, 8 minutes UVA corneal irradiation continuous mode.
Outcomes
Primary Outcome Measures
Corneal healing
Reepithelization of corneal ulcer which is measured in mm by slitlamp examination
Corneal edema
measurement of corneal edema by measurement of the corneal thickness in um by Optical Coherent Tomography
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04383431
Brief Title
Cross-linking as Treatment in Infectious Keratitis
Official Title
Standard Cross-linking Versus Accelerated Photoactivated Chromophore Cross-linking (PACK-CXL) for Treatment of Infectious Keratitis: A Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 2, 2020 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
January 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To compare between SCXL and ACXL for treatment of infectious keratitis
Detailed Description
Standard epithelium-off CXL, 30 minutes soaking time with riboflavin, 30 minutes UVA corneal irradiation continuous mode (Group A). Accelerated CXL 11 minutes soaking time with riboflavin, 8 minutes UVA corneal irradiation pulsed mode (Group B).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Keratitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard CXL
Arm Type
Experimental
Arm Description
Standard epithelium-off CXL, 30 minutes soaking time with riboflavin, 30 minutes UVA corneal irradiation continuous mode.
Arm Title
Accelerated CXL
Arm Type
Experimental
Arm Description
Accelerated epithelium-off CXL, 12 minutes soaking time with riboflavin, 8 minutes UVA corneal irradiation continuous mode.
Intervention Type
Procedure
Intervention Name(s)
PACK-CXL
Intervention Description
Standard epithelium-off CXL, 12 minutes soaking time with riboflavin, 8 minutes UVA corneal irradiation pulsed mode.
Primary Outcome Measure Information:
Title
Corneal healing
Description
Reepithelization of corneal ulcer which is measured in mm by slitlamp examination
Time Frame
3 months
Title
Corneal edema
Description
measurement of corneal edema by measurement of the corneal thickness in um by Optical Coherent Tomography
Time Frame
3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Fungal infectious keratitis
bacterial infectious keratitis
Must be not responding to medication
Exclusion Criteria:
Viral keratitis
Pregnancy and lactation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Iqbal, MD. PhP
Organizational Affiliation
00201068559840
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine
City
Sohag
ZIP/Postal Code
82425
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data will be allowed for sharing
IPD Sharing Time Frame
12 months after end of study
IPD Sharing Access Criteria
Ophthalmologists are allowed for access of data. they should email the principal investigator via dr_m_iqbal@yahoo.com to get the permission after reviewing the qualifications and quality of request
Learn more about this trial
Cross-linking as Treatment in Infectious Keratitis
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