Pack Cross Linking for Infectious Keratitis
Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05881187
Collaborator
(none)
60
1
3
11.6
5.2
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Analysis of the Outcomes of Photoactivated Chromophore for Keratitis Cross _linking for Treatment of Infectious Keratitis
Anticipated Study Start Date
:
Jun 15, 2023
Anticipated Primary Completion Date
:
Apr 1, 2024
Anticipated Study Completion Date
:
Jun 1, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: groupA (control group) will include 20 eyes of 20 patients with infectious keratitis who will receive antimicrobial therapy. |
Drug: Antibotice.g vigamox ED Antifungal e.g Dflucan
topical application of antimicropial therapy
|
| Active Comparator: group B 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 |
Drug: Riboflavin
topical application of riboflavin followed by cross linking
Drug: Antibotice.g vigamox ED Antifungal e.g Dflucan
topical application of antimicropial therapy
Device: pack cross linking
TOPICAL application of cross linking after application of Riboflavin TO TREAT INFECTIOUS KERATITIS
|
| Active Comparator: group C 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 |
Drug: Riboflavin
topical application of riboflavin followed by cross linking
Drug: Antibotice.g vigamox ED Antifungal e.g Dflucan
topical application of antimicropial therapy
Device: pack cross linking
TOPICAL application of cross linking after application of Riboflavin TO TREAT INFECTIOUS KERATITIS
|
Outcome Measures
Primary Outcome Measures
- corneal THICKNESS [within 60 days]
decrease corneal THICKNESS USING ANTERIOR SEGMENT OPTICAL COHERENT TOPOGRAPHY
Eligibility Criteria
Criteria
Ages Eligible for Study:
16 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sohag University Hospital | Sohag | Egypt |
Sponsors and Collaborators
- Sohag University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
Responsible Party:
Mariam Abdelmawgoud Mohamed,
assistant lecteurer opthalmology department sohag univerisity hospital,
Sohag University
ClinicalTrials.gov Identifier:
NCT05881187
Other Study ID Numbers:
- Pack cross linking
First Posted:
May 31, 2023
Last Update Posted:
May 31, 2023
Last Verified:
May 1, 2023
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
Additional relevant MeSH terms: