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Completed

NCT Number: NCT04054817

ACRO Biocornea Clinical Trial in Taiwan

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).

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Key information

Conditions

Corneal Ulcer Corneal Diseases Eye Diseases Eye Infections Infections Keratitis

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City, Taiwan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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
  • 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

Treatment and study plan

Lamellar keratoplasty-ABCcolla® Collagen Ophthalmic Matrix

Device

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

Other names: ACRO Biocornea

Primary outcomes

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

    Time frame: 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 outcomes

  1. The extent of graft transparency

    Time frame: 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.

  2. The extent of graft vascularization

    Time frame: 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.

  3. Infection recurrence

    Time frame: 24-week follow-up visit. Totoa 9 times.

    The recurrence was examined via slit lamp by the clinical ophthalmologist.

  4. The extend of corneal edema

    Time frame: 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.

  5. Best corrected vision acuity

    Time frame: 24-week follow-up visit. Totoa 9 times.

    Examied by the Optometer.

  6. Light sensitivity

    Time frame: 24-week follow-up visit. Totoa 9 times.

    The light perception was tested by the clinical ophthalmologist.

Sponsors and collaborators

Lead sponsor

ACRO Biomedical Co. Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Aug 13, 2019
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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