ACRO Biocornea Clinical Trial in Taiwan

Study Overview
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Brief Summary
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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).

Official Title
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A Multicenter, Open-label, Single-arm Study Assess the Collagen Ophthalmic Matrix for Anterior Lamellar Keratoplasty.

Conditions
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Corneal Ulcer

Intervention / Treatment
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* Device: Lamellar keratoplasty-ABCcolla® Collagen Ophthalmic Matrix


Participation Criteria
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Eligibility Criteria
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1. 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 2. 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 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 Cannot accept investigated material due to religious or cultural reason Pregnant or breastfeeding women or childbearing-age women who plan to get pregnant Participation in any drug or medical device clinical trial within 30 days prior to signing the informed consent form; Not being considered suitable for this study by the investigator

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br> | Device: Lamellar keratoplasty-ABCcolla® Collagen Ophthalmic Matrix<br>* Lamellar keratoplasty was done by removing stromal layer, ABCcolla® Collagen Ophthalmic Matrix was sutured to the defective part of the cornea.<br>* Other names: ACRO Biocornea;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The extent of graft transparency | 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. | 24-week follow-up visit. Totoa 9 times. | 
| The extent of graft vascularization | 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. | 24-week follow-up visit. Totoa 9 times. | 
| Infection recurrence | The recurrence was examined via slit lamp by the clinical ophthalmologist. | 24-week follow-up visit. Totoa 9 times. | 
| The extend of corneal edema | After examined via OCT by the clinical ophthalmologist, the corneal edema were graded from none, mild, moderate and severe by the doctor. | 24-week follow-up visit. Totoa 9 times. | 
| Best corrected vision acuity | Examied by the Optometer. | 24-week follow-up visit. Totoa 9 times. | 
| Light sensitivity | The light perception was tested by the clinical ophthalmologist. | 24-week follow-up visit. Totoa 9 times. |