Health Condition 1: H160- Corneal ulcer
Conditions
Interventions
Intervention1: ABCcolla® Collagen Ophthalmic Matrix
(Decellularized porcine collagen corneal matrix will be applied during Anterior Lamellar Keratoplasty surgery only): Duration: Subjects will be fo
Sponsors
ACRO Biomedical Co Ltd
Raptim Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male or female aged 20 to 60 years Patient who has been diagnosed with corneal ulcer due to bacterial, fungal or parasite infection not responding to medical treatment for one to two weeks for bacterial or fungal keratitis and a minimum of one month for parasitic infection; exposure to chemical burns classified as Grade III or IV; or severe trauma not responding to medical treatment The corneal ulcer affects corneal stroma depth to more than one third and less than two thirds of the stroma and infiltrate more than three millimeters and less than ten millimeters in diameter, detected by Optical Coherence Tomography Best Corrected Visual Acuity of less than 0.05 as measured on the logMAR chart, equivalent to Snellen notation 20 over 400 in feet or 6 over 120 in meters Patient or impartial witness who signs the informed consent form and agrees to complete the treatment and follow-up Patients who are not responsive to treatment for one to two weeks for bacterial or fungal keratitis and a minimum of one month for parasitic infection
Exclusion criteria
Exclusion criteria: Treated with keratoplasty before Has a corneal ulcer smaller than 3 mm or larger than 10 mm in diameter Has corneal ulcer infiltrates less than one third or more than two thirds in depth Has severe dry eye disease as assessed by Schirmers Test II less than 5 mm Has cataracts on the eyes Experiences incomplete eyelid closure Has liver function ALT and AST tests with the score as two fold or greater than that of the normal Has renal function creatinine Cr level greater than two fold of the normal Has serum albumin level lower than 10 percent of normal value Has severe cardiovascular and cerebral vascular disease Has diabetes Has a malignant or benign tumor Known to be allergic to collagen Has a systemic collagen connective tissue disease Has allergic reactions to porcine tissue Use of anticoagulants five days before screening Use of topical oral or injectable NSAIDs three days before screening The patient does not accept porcine tissue for any reason Pregnant or breastfeeding women or childbearing age women who plan to get pregnant Participates in other drug or medical instrument clinical trials in the last 12 weeks Not being considered suitable for this study by the principal investigator Has glaucoma Cases with defective limbus or cornea without limbus or severe injury to limbus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of irreversible graft dissociation melting or rejection up to 6 months Adverse events TEAE Timepoint: Up to 6 months 24 weeks post implantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Graft transparency Neovascularization Infection recurrence Edema BCVA Vital signs Lab tests Epithelial reconstruction IOP, graft and bed thickness Timepoint: Up to 6 months 24 weeks post implantation | — |
Countries
India
Contacts
Public ContactDr Siddhartha Patil
Raptim Research Pvt. Ltd
Outcome results
None listed