Trials / Completed
CompletedNCT04054817
ACRO Biocornea Clinical Trial in Taiwan
A Multicenter, Open-label, Single-arm Study Assess the Collagen Ophthalmic Matrix for Anterior Lamellar Keratoplasty.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- ACRO Biomedical Co. Ltd · Industry
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Lamellar 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. |
Timeline
- Start date
- 2020-11-02
- Primary completion
- 2022-10-05
- Completion
- 2023-03-06
- First posted
- 2019-08-13
- Last updated
- 2023-04-19
Locations
3 sites across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT04054817. Inclusion in this directory is not an endorsement.