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First-In-Man Study for an Ophthalmic Synthetic Tissue Substitute

NCT04037917 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-09-07

No results posted yet for this study

Summary

Study Name: The CorNeat EverPatch - a First-In-Man Clinical Study for demonstrating the Safety of a Synthetic Tissue Substitute for concealment of artificial implants and glaucoma tube shunts

Objective: The objective of this clinical trial is to demonstrate the Safety of the Corneat Everpatch for concealment of artificial implants and glaucoma tube shunts

The study will consist 10 subjects requiring concealment of a glaucoma shunt or other ophthalmic implant. Eligible subjects who signs an ICF will be enrolled to the study. Subjects will be implanted with the Corneart EverPatch as part of a glaucoma shunt surgery or during a corrective surgery to repair a breached conjunctiva over an implanted device. Subjects will be monitored for a period of 12 months post-op during which follow up visits will occur at 1 week, 1, 2, 3, 6, 9 \& 12 months following surgery including clinical examination of the operated eye using slit-lamp biomicroscopy and imaging using OCT or UBM (will be performed only at the 6 \& 12 months follow up visits).

Conditions

  • Glaucoma Eye
  • Tissue Breakdown

Interventions

DEVICE

CorNeat EverPatch

Covering Ophthalmic Implants

Sponsors & Collaborators

  • CorNeat Vision Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-11
Primary Completion
2023-04-30
Completion
2023-07-01

Countries

  • Canada
  • France
  • Kenya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04037917 on ClinicalTrials.gov