Safety and Effectiveness of Collagen-phosphorylcholine Bioengineered Cornea in Patients Requiring Lamellar Keratoplasty

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02277054
• Date of registration: 26/10/2014
• Prospective Registration: No
• Primary sponsor: The Filatov Institute of Eye Diseases and Tissue Therapy
• Public title: Safety and Effectiveness of Collagen-phosphorylcholine Bioengineered Cornea in Patients Requiring Lamellar Keratoplasty
• Scientific title: A Clinical Trial to Evaluate the Safety and Effectiveness of the Collagen-phosphorylcholine Corneal Substitutes in Patients Requiring Lamellar Keratoplasty
• Date of first enrolment: March 2013
• Target sample size: 5
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02277054
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Ukraine

Contacts

• Name: Nataliya Pasyechnikova, MD, PhD, DSc
• Affiliation: The Filatov Institute of Eye Diseases and Tissue Therapy

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subjects must sign and be given a copy of the written Informed Consent form.

2. Subjects with best corrected distance visual acuity 20/200 or worse as a result of
corneal ulcer or corneal scar due to burn, injury or infection in the operative eye.

3. Subjects must be willing and able to return for scheduled follow-up examinations for
12 months after surgery.

Exclusion Criteria:

1. Subjects with severe or life-threatening systemic disease.

2. Subjects with uncontrolled hypertension.

3. Subjects with uncontrolled diabetes or insulin-dependent diabetes.

4. Subjects with glaucoma in either eye.

5. Subjects with marked microphthalmos or aniridia in either eye.

6. Subjects with any other serious ocular pathology, serious ocular complications at the
time of corneal transplant underlying serious medical conditions, based on the
investigator's medical judgment.

7. Subjects which are or lactating or who plan to become pregnant over the course of the
clinical investigation.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Corneal Ulcer

Leukoma

Intervention(s)

Device: Collagen-MPC cornea

Primary Outcome(s)

Incidence of Treatment-Emergent Adverse Events [Time Frame: 12 months]

Secondary Outcome(s)

Number of Participants With Improved Visual Acuity at 12 Months [Time Frame: 12 months]

Number of Participants With Healed Cornea at 12 Months [Time Frame: 12 months]

Secondary ID(s)

03/2013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Linkoeping University

Results

• Results available: Yes
• Date Posted: 26/10/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02277054