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ACRO Biocornea Clinical Trial in Taiwan

NCT04054817 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-04-19

No results posted yet for this study

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

  • Corneal Ulcer

Interventions

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.

Sponsors & Collaborators

  • ACRO Biomedical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Ming-Cheng Tai, MD · Tri-Service General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-02
Primary Completion
2022-10-05
Completion
2023-03-06

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04054817 on ClinicalTrials.gov