Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04054817
Other study ID # AC-2017-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2, 2020
Est. completion date March 6, 2023

Study information

Verified date April 2023
Source ACRO Biomedical Co. Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date March 6, 2023
Est. primary completion date October 5, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 1. Inclusion criteria: 1. Male or female from 20 to 80 years old 2. Subject who has been diagnosed with corneal ulcer 3. The depth or the size of the ulcer increases or increased anterior chamber inflammation after treatment (clinic, hospitalization, or others…) 4. The corneal ulcer affects corneal stroma depth to 1/3 and infiltrates >2 mm diameter, detected by OCT 5. Best corrected vision acuity < 0.05 6. Subject who signs the informed consent form (ICF), and agrees to complete the treatment and follow-up 2. Exclusion criteria: 1. Accepted keratoplasty 2. Has a corneal perforation and expects to have vision 3. Has a severe dry eye 4. Experience s incomplete eyelid closure 5. H as liver function (ALT and AST) tests with the score as twofold or greater than that of the normal 6. Has renal function (Cr) levels greater than normal two folders 7. Has serum protein 10% low than normal 8. Has severe cardiovascular and cerebral vascular disease 9. Subject with uncontrolled diabetes 10. Subject with current malignancy 11. Known to be allergic to collagen 12. Has a systemic collagen connective tissue disease 13. Has a constitution prone to severe allergic reactions 14. Use s anticoagulants 5 days before studying keratoplasty 15. Use s injectable NSAID 3 days before studying keratoplasty 16. Cannot accept investigated material due to religious or cultural reason 17. Pregnant or breastfeeding women or childbearing-age women who plan to get pregnant 18. Participation in any drug or medical device clinical trial within 30 days prior to signing the informed consent form; 19. Not being considered suitable for this study by the investigator

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung
Taiwan Kaohsiung Veterans General Hospital Kaohsiung
Taiwan Tri-Service General Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
ACRO Biomedical Co. Ltd

Country where clinical trial is conducted

Taiwan, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
Secondary 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.
Secondary Infection recurrence The recurrence was examined via slit lamp by the clinical ophthalmologist. 24-week follow-up visit. Totoa 9 times.
Secondary 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.
Secondary Best corrected vision acuity Examied by the Optometer. 24-week follow-up visit. Totoa 9 times.
Secondary Light sensitivity The light perception was tested by the clinical ophthalmologist. 24-week follow-up visit. Totoa 9 times.
See also
  Status Clinical Trial Phase
Recruiting NCT05705024 - Efficacy of Locally Delivered Allogeneic Mesenchymal Stromal Cells Phase 2
Completed NCT02731638 - Mycotic Antimicrobial Localized Injection for Treatment of Corneal Ulcers Phase 3
Completed NCT00324168 - Steroids for Corneal Ulcers Trial Phase 4
Completed NCT04484402 - Treatment of Patients With Inflammatory-dystrophic Diseases of the Cornea Using Autologous Stem Cells Phase 1/Phase 2
Completed NCT04820010 - Topical Insulin - Utility and Results in Neurotrophic Keratopathy in Stages 2 and 3
Recruiting NCT02570321 - Cross-linking for Corneal Ulcers Treatment Trial Phase 4
Completed NCT00386958 - A Clinical Trial of Povidone-Iodine for the Treatment of Bacterial Corneal Ulcers Phase 2
Completed NCT00997035 - The Mycotic Ulcer Treatment Trial II: A Randomized Trial Comparing Oral Voriconazole vs Placebo Phase 3
Completed NCT02277054 - Safety and Effectiveness of Collagen-phosphorylcholine Bioengineered Cornea in Patients Requiring Lamellar Keratoplasty N/A
Recruiting NCT05313828 - Effect of Various Treatment Modalities on Dendritic Vial Ulcer
Recruiting NCT05255107 - Safety and Effectiveness of the PXL Platinum 330 System With Riboflavin Solution for Previously Untreated Corneal Ulcers Phase 2/Phase 3
Recruiting NCT05255016 - Safety and Effectiveness of the PXL Platinum 330 System With Riboflavin Solution for Refractory Corneal Ulcers Phase 2/Phase 3
Completed NCT05891106 - AONDA Therapeutic Indication Study I
Terminated NCT00789646 - Painless Subconjunctival Antibiotic and Antifungal Injection in Corneal Ulcer Patients N/A
Not yet recruiting NCT05940376 - Topical Insulin in Neurotrophic Keratopathy After Diabetic Vitrectomy
Completed NCT05200000 - Wharton's Jelly Eye Drops in the Treatment of Chronic Keratitis Phase 1
Completed NCT01756456 - Evaluation of Safety and Efficacy of rhNGF in Patients With Stage 2 and 3 Neurotrophic Keratitis. Phase 1/Phase 2
Active, not recruiting NCT01969786 - Village Integrated Eye Workers Trial N/A
Completed NCT01794312 - Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer Phase 3
Completed NCT04837534 - Improving the Follow up Rate for Pediatric Patients N/A