Crosslinking in Infectious Keratitis
Primary Purpose
Infectious Keratitis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Crosslinking with Riboflavin and UV-A
Sponsored by
About this trial
This is an interventional treatment trial for Infectious Keratitis
Eligibility Criteria
Inclusion Criteria:
- Patients with proved bacterial, fungal, acanthamoeba microbial keratitis .
- Patient willing to comply with all study procedures .
Exclusion Criteria:
- Severe corneal scarring or opacification .
- Patients with viral infectious keratitis
- Prior herpetic infections .
- Patients with any coexisting ocular pathology,ocular surface disease .
- Patients with Autoimmune disease.
- Pregnant women .
- Corneal Thickness of less than 400 microns .
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CXL on patients with infectious keratitis
Arm Description
the procedure of cross linking(CXL) :combined riboflavin-ultraviolet type A rays (UVA) collagen cross-linking. Radiant energy was 3 milliwatts/cm2 for a 30-minute exposure irradiation of the cornea will be carried out on twenty patients with infectious keratitis .
Outcomes
Primary Outcome Measures
Determine the duration for corneal ulcer healing
By follow up with photography before crosslinking and one week after performing cxl.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03801590
Brief Title
Crosslinking in Infectious Keratitis
Official Title
Safety and Efficacy Of Corneal Collagen Crosslinking (CXL) In Infectious Keratitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2021 (Anticipated)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut 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
Microbial keratitis is an infection of the cornea that is associated with risk of permanent visual impairment.
It can be caused by bacteria, virus, fungus, protozoa and parasites. The common risk factors for infectious keratitis include ocular trauma, contact lens wear, recent ocular surgery, preexisting ocular surface disease, dry eyes, lid deformity, corneal sensation impairment, chronic use of topical steroids and systemic immunosuppression .
Detailed Description
The spectrum of bacterial keratitis can also be influenced by geographic and climatic factors.
The treatment usually consist of Topical administered antibiotics .the emergence of multidrug-resistant bacteria is a concern that might complicate the treatment and cure of infectious keratitis.
Collagen cross linking (CXL) using ultraviolet-A (UV-A) and riboflavin in a treatment that was developed to increase the biochemical strength of the cornea The procedure is based on using riboflavin as a photosensitizer, which generates reactive oxygen species when activated by UV-A at 365 or370 nm.
The standard technique (epi-off) also called Dresden Protocol includes removal of the epithelium in order to expose the underlying stroma to riboflavin, which is otherwise incompletely absorbed by the epithelium because of tight junctions. The area of corneal epithelium removed has a diameter of 6.0 to 8.5 mm. A crosslinking procedure without epithelial removal could also be performed (epi-on). It would likely be less painful compared to the standard procedure.
The crosslinking process generates reactive oxygen species that can damage the cell walls of pathogens. CXL induces formation of new covalent bonds thereby rendering the corneal stroma biomechanically stronger and more resistant to enzymatic digestion . This can potentially limit the spread of infection. Furthermore, CXL-induced apoptosis could contribute to the reduction of inflammatory response during corneal infection .
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CXL on patients with infectious keratitis
Arm Type
Experimental
Arm Description
the procedure of cross linking(CXL) :combined riboflavin-ultraviolet type A rays (UVA) collagen cross-linking. Radiant energy was 3 milliwatts/cm2 for a 30-minute exposure irradiation of the cornea will be carried out on twenty patients with infectious keratitis .
Intervention Type
Device
Intervention Name(s)
Crosslinking with Riboflavin and UV-A
Intervention Description
the procedure of cross linking(CXL) :combined riboflavin-ultraviolet type A rays (UVA) collagen cross-linking. Radiant energy was 3 milliwatts/cm2 for a 30-minute exposure irradiation of the cornea.
Primary Outcome Measure Information:
Title
Determine the duration for corneal ulcer healing
Description
By follow up with photography before crosslinking and one week after performing cxl.
Time Frame
one year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with proved bacterial, fungal, acanthamoeba microbial keratitis .
Patient willing to comply with all study procedures .
Exclusion Criteria:
Severe corneal scarring or opacification .
Patients with viral infectious keratitis
Prior herpetic infections .
Patients with any coexisting ocular pathology,ocular surface disease .
Patients with Autoimmune disease.
Pregnant women .
Corneal Thickness of less than 400 microns .
12. IPD Sharing Statement
Citations:
PubMed Identifier
18245962
Citation
Green M, Apel A, Stapleton F. Risk factors and causative organisms in microbial keratitis. Cornea. 2008 Jan;27(1):22-7. doi: 10.1097/ICO.0b013e318156caf2.
Results Reference
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PubMed Identifier
20543933
Citation
Jankov Ii MR, Jovanovic V, Nikolic L, Lake JC, Kymionis G, Coskunseven E. Corneal collagen cross-linking. Middle East Afr J Ophthalmol. 2010 Jan;17(1):21-7. doi: 10.4103/0974-9233.61213.
Results Reference
background
Learn more about this trial
Crosslinking in Infectious Keratitis
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