ACRO Biocornea Clinical Trial in Taiwan

Not Applicable

Completed

• Conditions: Corneal Ulcer
• Interventions: Device: Lamellar keratoplasty-ABCcolla® Collagen Ophthalmic Matrix

• Registration Number: NCT04054817
• Lead Sponsor: ACRO Biomedical Co. Ltd

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-09
• Study First Submitted QC: 2019-08-09
• Study First Posted: 2019-08-13
• Study Start: 2020-11-02
• Primary Completion: 2022-10-05
• Study Completion: 2023-03-06
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-17
• Last Update Posted: 2023-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Lamellar keratoplasty-ABCcolla® Collagen Ophthalmic Matrix	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
Best corrected vision acuity	24-week follow-up visit. Totoa 9 times.	Examied by the Optometer.
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.
Infection recurrence	24-week follow-up visit. Totoa 9 times.	The recurrence was examined via slit lamp by the clinical ophthalmologist.
Light sensitivity	24-week follow-up visit. Totoa 9 times.	The light perception was tested by the clinical ophthalmologist.

Trial Locations

Locations (3)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan