Back to resultsPack Cross Linking for Infectious Keratitis
Primary Purpose
Infectoius Keratitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Riboflavin
Antibotice.g vigamox ED Antifungal e.g Dflucan
pack cross linking
Sponsored by
About this trial
This is an interventional treatment trial for Infectoius Keratitis
Eligibility Criteria
Inclusion Criteria: are age ≥18 years, fungal, bacterial or mixed infectious keratitis, ulcer ≤ 4 mm in diameter and showing a maximum depth of 350 μm (as assessed by either optical coherence tomography (OCT)) Exclusion Criteria: age ≤18 years, viral infectious keratitis, non-infectiouskeratitis, melting corneal ulcers with impending perforation, corneal thickness < 400 μm (including the corneal epithelium) and systemic diseases or systemic surgery, single-eyed and immunosuppressed patients.
Sites / Locations
- Sohag University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
groupA (control group)
group B
group C
Arm Description
will include 20 eyes of 20 patients with infectious keratitis who will receive antimicrobial therapy.
will include 20 eyes of 20 patients with infectious keratitis who will undergo PACK accelerated cross-linking Protocol-1 (9 mW/cm2 for 10 minutes to achieve 5.4 J/cm2) followed by antimicrobial therapy
will include 20 eyes of 20 patients with infectious keratitis who will undergo PACK accelerated crosslinking Protocol-2 (18 mW/cm2 for 7 minutes to achieve 7.2 J/cm2) followed by antimicrobial therapy
Outcomes
Primary Outcome Measures
corneal THICKNESS
decrease corneal THICKNESS USING ANTERIOR SEGMENT OPTICAL COHERENT TOPOGRAPHY
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05881187
Brief Title
Pack Cross Linking for Infectious Keratitis
Official Title
Analysis of the Outcomes of Photoactivated Chromophore for Keratitis Cross _linking for Treatment of Infectious Keratitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 15, 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary aim of this study is to investigate the efficiency of PACK_ CXL in treatment of infectious keratitis and analyze postoperative outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectoius Keratitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
groupA (control group)
Arm Type
Active Comparator
Arm Description
will include 20 eyes of 20 patients with infectious keratitis who will receive antimicrobial therapy.
Arm Title
group B
Arm Type
Active Comparator
Arm Description
will include 20 eyes of 20 patients with infectious keratitis who will undergo PACK accelerated cross-linking Protocol-1 (9 mW/cm2 for 10 minutes to achieve 5.4 J/cm2) followed by antimicrobial therapy
Arm Title
group C
Arm Type
Active Comparator
Arm Description
will include 20 eyes of 20 patients with infectious keratitis who will undergo PACK accelerated crosslinking Protocol-2 (18 mW/cm2 for 7 minutes to achieve 7.2 J/cm2) followed by antimicrobial therapy
Intervention Type
Drug
Intervention Name(s)
Riboflavin
Intervention Description
topical application of riboflavin followed by cross linking
Intervention Type
Drug
Intervention Name(s)
Antibotice.g vigamox ED Antifungal e.g Dflucan
Intervention Description
topical application of antimicropial therapy
Intervention Type
Device
Intervention Name(s)
pack cross linking
Intervention Description
TOPICAL application of cross linking after application of Riboflavin TO TREAT INFECTIOUS KERATITIS
Primary Outcome Measure Information:
Title
corneal THICKNESS
Description
decrease corneal THICKNESS USING ANTERIOR SEGMENT OPTICAL COHERENT TOPOGRAPHY
Time Frame
within 60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
are age ≥18 years, fungal, bacterial or mixed infectious keratitis, ulcer ≤ 4 mm in diameter and showing a maximum depth of 350 μm (as assessed by either optical coherence tomography (OCT))
Exclusion Criteria:
age ≤18 years, viral infectious keratitis, non-infectiouskeratitis, melting corneal ulcers with impending perforation, corneal thickness < 400 μm (including the corneal epithelium) and systemic diseases or systemic surgery, single-eyed and immunosuppressed patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mariam A mohamed, assistant lecteure
Phone
01150960676
Email
mariam-abdelmawgoud@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed i hafez, professor
Phone
01068559840
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
magdy m ameen, professor
12. IPD Sharing Statement
Citations:
PubMed Identifier
35610943
Citation
Cabrera-Aguas M, Khoo P, Watson SL. Infectious keratitis: A review. Clin Exp Ophthalmol. 2022 Jul;50(5):543-562. doi: 10.1111/ceo.14113. Epub 2022 Jun 3.
Results Reference
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PubMed Identifier
26509768
Citation
Papaioannou L, Miligkos M, Papathanassiou M. Corneal Collagen Cross-Linking for Infectious Keratitis: A Systematic Review and Meta-Analysis. Cornea. 2016 Jan;35(1):62-71. doi: 10.1097/ICO.0000000000000644.
Results Reference
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PubMed Identifier
27096139
Citation
Tabibian D, Mazzotta C, Hafezi F. PACK-CXL: Corneal cross-linking in infectious keratitis. Eye Vis (Lond). 2016 Apr 19;3:11. doi: 10.1186/s40662-016-0042-x. eCollection 2016.
Results Reference
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PubMed Identifier
15339215
Citation
Kumar V, Lockerbie O, Keil SD, Ruane PH, Platz MS, Martin CB, Ravanat JL, Cadet J, Goodrich RP. Riboflavin and UV-light based pathogen reduction: extent and consequence of DNA damage at the molecular level. Photochem Photobiol. 2004 Jul-Aug;80:15-21. doi: 10.1562/2003-12-23-RA-036.1.
Results Reference
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Pack Cross Linking for Infectious Keratitis
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