The goal of this clinical trial is to investigate the safety and clinical performance of ABCcolla Collagen Ophthalmic Matrix used for anterior lamellar keratoplasty in patients suffering from corneal ulcer. Participants will undergo keratoplasty using the investigational product and be followed up for 24-week observation (total of 10 times).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Lamellar keratoplasty was done by removing stromal layer, ABCcolla® Collagen Ophthalmic Matrix was sutured to the defective part of the cornea.
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Incidence rate of irreversible graft dissociation or irreversible graft rejection within 6 months.
Count the number of subjects with irreversible graft dissolution or irreversible rejection within 24 weeks, and calculate the incidence rate
Time frame: After the surgery, patients will be examined for follow-up observation for 24 weeks.
The extent of graft transparency
After examined via slit lamp by the clinical ophthalmologist, the graft transparency were graded from 0 to 4, which indicated transparency, slight turbidity, mild turbidity of matrix and visble iris, worsening turbidity with invisible iris, and invisible pupil, respectively.
Time frame: 24-week follow-up visit. Totoa 9 times.
The extent of graft vascularization
After examined via slit lamp by the clinical ophthalmologist, the extent of neovascularization was grades 0 if there were none, 1-4 if neovascularization had grown into the corneal limbus, the border of graft, 2mm of the gtaft, and into the center of the graft, respectively.
Time frame: 24-week follow-up visit. Totoa 9 times.
Infection recurrence
The recurrence was examined via slit lamp by the clinical ophthalmologist.
Time frame: 24-week follow-up visit. Totoa 9 times.
The extend of corneal edema
After examined via OCT by the clinical ophthalmologist, the corneal edema were graded from none, mild, moderate and severe by the doctor.
Time frame: 24-week follow-up visit. Totoa 9 times.
Best corrected vision acuity
Examied by the Optometer.
Time frame: 24-week follow-up visit. Totoa 9 times.
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Light sensitivity
The light perception was tested by the clinical ophthalmologist.
Time frame: 24-week follow-up visit. Totoa 9 times.