ACRO Biocornea Clinical Trial in Taiwan

ACRO Biomedical

Status: Completed

Conditions: Corneal Ulcer

Treatments: Device: Lamellar keratoplasty-ABCcolla® Collagen Ophthalmic Matrix

Study type: Interventional

Funder types: Industry

Identifiers

NCT04054817

AC-2017-01

Details and patient eligibility

About

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).

Enrollment: 6 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Inclusion criteria:

2. Male or female from 20 to 80 years old

3. Subject who has been diagnosed with corneal ulcer

4. The depth or the size of the ulcer increases or increased anterior chamber inflammation after treatment (clinic, hospitalization, or others...)

5. The corneal ulcer affects corneal stroma depth to 1/3 and infiltrates >2 mm diameter, detected by OCT

6. Best corrected vision acuity < 0.05

7. Subject who signs the informed consent form (ICF), and agrees to complete the treatment and follow-up

8. Exclusion criteria:

9. Accepted keratoplasty

10. Has a corneal perforation and expects to have vision

11. Has a severe dry eye

12. Experience s incomplete eyelid closure

13. H as liver function (ALT and AST) tests with the score as twofold or greater than that of the normal

14. Has renal function (Cr) levels greater than normal two folders

15. Has serum protein 10% low than normal

16. Has severe cardiovascular and cerebral vascular disease

17. Subject with uncontrolled diabetes

18. Subject with current malignancy

19. Known to be allergic to collagen

20. Has a systemic collagen connective tissue disease

21. Has a constitution prone to severe allergic reactions

22. Use s anticoagulants 5 days before studying keratoplasty

23. Use s injectable NSAID 3 days before studying keratoplasty

24. Cannot accept investigated material due to religious or cultural reason

25. Pregnant or breastfeeding women or childbearing-age women who plan to get pregnant

26. Participation in any drug or medical device clinical trial within 30 days prior to signing the informed consent form;

27. Not being considered suitable for this study by the investigator

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Single Arm

Experimental group

Treatment:

Device: Lamellar keratoplasty-ABCcolla® Collagen Ophthalmic Matrix