Status:
COMPLETED
ACRO Biocornea Clinical Trial in Taiwan
Lead Sponsor:
ACRO Biomedical Co. Ltd
Conditions:
Corneal Ulcer
Eligibility:
All Genders
20-80 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 1\. Inclusion criteria:
- Male or female from 20 to 80 years old
- Subject who has been diagnosed with corneal ulcer
- The depth or the size of the ulcer increases or increased anterior chamber inflammation after treatment (clinic, hospitalization, or others…)
- The corneal ulcer affects corneal stroma depth to 1/3 and infiltrates \>2 mm diameter, detected by OCT
- Best corrected vision acuity \< 0.05
- Subject who signs the informed consent form (ICF), and agrees to complete the treatment and follow-up
- 2\. Exclusion criteria:
- Accepted keratoplasty
- Has a corneal perforation and expects to have vision
- Has a severe dry eye
- Experience s incomplete eyelid closure
- H as liver function (ALT and AST) tests with the score as twofold or greater than that of the normal
- Has renal function (Cr) levels greater than normal two folders
- Has serum protein 10% low than normal
- Has severe cardiovascular and cerebral vascular disease
- Subject with uncontrolled diabetes
- Subject with current malignancy
- Known to be allergic to collagen
- Has a systemic collagen connective tissue disease
- Has a constitution prone to severe allergic reactions
- Use s anticoagulants 5 days before studying keratoplasty
- Use s injectable NSAID 3 days before studying keratoplasty
- Cannot accept investigated material due to religious or cultural reason
- Pregnant or breastfeeding women or childbearing-age women who plan to get pregnant
- Participation in any drug or medical device clinical trial within 30 days prior to signing the informed consent form;
- Not being considered suitable for this study by the investigator
Exclusion
Key Trial Info
Start Date :
November 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04054817
Start Date
November 2 2020
End Date
March 6 2023
Last Update
April 19 2023
Active Locations (3)
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1
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
2
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
3
Tri-Service General Hospital
Taipei, Taiwan