CompletedNot Applicable

ACRO Biocornea Clinical Trial in Taiwan

Taiwan6 participantsStarted 2020-11-02

Plain-language 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).

Who can participate

Age range20 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

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

What they're measuring

Incidence rate of irreversible graft dissociation or irreversible graft rejection within 6 months.

Timeframe: After the surgery, patients will be examined for follow-up observation for 24 weeks.

Trial details

NCT IDNCT04054817

SponsorACRO Biomedical Co. Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-10-05

View on ClinicalTrials.gov More Corneal Ulcer trials