NCT04054817

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 2, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2023

Completed
Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

1.9 years

First QC Date

August 9, 2019

Last Update Submit

April 17, 2023

Conditions

Corneal Ulcer

Outcome Measures

Primary Outcomes (1)

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

    Count the number of subjects with irreversible graft dissolution or irreversible rejection within 24 weeks, and calculate the incidence rate

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

Secondary Outcomes (6)

  • The extent of graft transparency

    24-week follow-up visit. Totoa 9 times.

  • The extent of graft vascularization

    24-week follow-up visit. Totoa 9 times.

  • Infection recurrence

    24-week follow-up visit. Totoa 9 times.

  • The extend of corneal edema

    24-week follow-up visit. Totoa 9 times.

  • Best corrected vision acuity

    24-week follow-up visit. Totoa 9 times.

  • +1 more secondary outcomes

Study Arms (1)

Single Arm

EXPERIMENTAL
Device: Lamellar keratoplasty-ABCcolla® Collagen Ophthalmic Matrix

Interventions

Lamellar keratoplasty-ABCcolla® Collagen Ophthalmic MatrixDEVICE

Lamellar keratoplasty was done by removing stromal layer, ABCcolla® Collagen Ophthalmic Matrix was sutured to the defective part of the cornea.

Also known as: ACRO Biocornea
Single Arm

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Location

Tri-Service General Hospital

Taipei, Taiwan

Location

Related Publications (1)

  • Huang YH, Tseng FW, Chang WH, Peng IC, Hsieh DJ, Wu SW, Yeh ML. Preparation of acellular scaffold for corneal tissue engineering by supercritical carbon dioxide extraction technology. Acta Biomater. 2017 Aug;58:238-243. doi: 10.1016/j.actbio.2017.05.060. Epub 2017 Jun 1.

    PMID: 28579539RESULT

MeSH Terms

Conditions

Corneal Ulcer

Condition Hierarchy (Ancestors)

Eye InfectionsInfectionsKeratitisCorneal DiseasesEye Diseases

Study Officials

  • Ming-Cheng Tai, MD

    Tri-Service General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2019

First Posted

August 13, 2019

Study Start

November 2, 2020

Primary Completion

October 5, 2022

Study Completion

March 6, 2023

Last Updated

April 19, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(3)