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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infectious Keratitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 7, 2019
    Last Updated
    July 19, 2021
    Sponsor
    Assiut University
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    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
    background
    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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