Crosslinking in Infectious Keratitis
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|ClinicalTrials.gov Identifier: NCT03801590|
Recruitment Status : Not yet recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
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 .
|Condition or disease||Intervention/treatment||Phase|
|Infectious Keratitis||Device: Crosslinking with Riboflavin and UV-A||Not Applicable|
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 .
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy Of Corneal Collagen Crosslinking (CXL) In Infectious Keratitis|
|Estimated Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||January 1, 2021|
Experimental: CXL on patients with infectious keratitis
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 .
Device: Crosslinking with Riboflavin and UV-A
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.
- Determine the duration for corneal ulcer healing [ Time Frame: one year ]By follow up with photography before crosslinking and one week after performing cxl.