Corneal Ulcer
Conditions
Brief summary
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).
Interventions
DEVICELamellar keratoplasty-ABCcolla® Collagen Ophthalmic Matrix
Lamellar keratoplasty was done by removing stromal layer, ABCcolla® Collagen Ophthalmic Matrix was sutured to the defective part of the cornea.
Sponsors
ACRO Biomedical Co. Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1\. Inclusion criteria: 1. Male or female from 20 to 80 years old 2. Subject who has been diagnosed with corneal ulcer 3. The depth or the size of the ulcer increases or increased anterior chamber inflammation after treatment (clinic, hospitalization, or others…) 4. The corneal ulcer affects corneal stroma depth to 1/3 and infiltrates \>2 mm diameter, detected by OCT 5. Best corrected vision acuity \< 0.05 6. Subject who signs the informed consent form (ICF), and agrees to complete the treatment and follow-up 2\.
Exclusion criteria
1. Accepted keratoplasty 2. Has a corneal perforation and expects to have vision 3. Has a severe dry eye 4. Experience s incomplete eyelid closure 5. H as liver function (ALT and AST) tests with the score as twofold or greater than that of the normal 6. Has renal function (Cr) levels greater than normal two folders 7. Has serum protein 10% low than normal 8. Has severe cardiovascular and cerebral vascular disease 9. Subject with uncontrolled diabetes 10. Subject with current malignancy 11. Known to be allergic to collagen 12. Has a systemic collagen connective tissue disease 13. Has a constitution prone to severe allergic reactions 14. Use s anticoagulants 5 days before studying keratoplasty 15. Use s injectable NSAID 3 days before studying keratoplasty 16. Cannot accept investigated material due to religious or cultural reason 17. Pregnant or breastfeeding women or childbearing-age women who plan to get pregnant 18. Participation in any drug or medical device clinical trial within 30 days prior to signing the informed consent form; 19. Not being considered suitable for this study by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of irreversible graft dissociation or irreversible graft rejection within 6 months. | After the surgery, patients will be examined for follow-up observation for 24 weeks. | Count the number of subjects with irreversible graft dissolution or irreversible rejection within 24 weeks, and calculate the incidence rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The extent of graft vascularization | 24-week follow-up visit. Totoa 9 times. | 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. |
| Infection recurrence | 24-week follow-up visit. Totoa 9 times. | The recurrence was examined via slit lamp by the clinical ophthalmologist. |
| The extent of graft transparency | 24-week follow-up visit. Totoa 9 times. | 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. |
| Best corrected vision acuity | 24-week follow-up visit. Totoa 9 times. | Examied by the Optometer. |
| Light sensitivity | 24-week follow-up visit. Totoa 9 times. | The light perception was tested by the clinical ophthalmologist. |
| The extend of corneal edema | 24-week follow-up visit. Totoa 9 times. | After examined via OCT by the clinical ophthalmologist, the corneal edema were graded from none, mild, moderate and severe by the doctor. |
Countries
Taiwan
Outcome results
None listed