NCT06174376

Clinical Outcomes of the Gore Synthetic Cornea Device

A Prospective, Multi-Center, Early Feasibility Study to Assess Clinical Outcomes of the GORE Synthetic Cornea Device in Patients With Loss of Corneal Clarity

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study objective is to evaluate the initial safety and effectiveness of the GORE Synthetic Cornea Device in the treatment of loss of corneal clarity in patients who are candidates for corneal transplantation

Detailed description

This is a prospective, single-arm, open-label, multi-center early feasibility clinical study designed to evaluate the clinical outcomes of the GORE Synthetic Cornea Device in the treatment of loss of corneal clarity in patients who are candidates for corneal transplantation. Following procedure, clinical follow up will be scheduled over the course of the study duration (12 months).

Conditions

• Corneal Opacity

Interventions

Type	Name	Description
DEVICE	GORE Synthetic Cornea Device	Treatment with GORE Synthetic Cornea Device

Timeline

• Start date: 2024-08-19
• Primary completion: 2026-12-31
• Completion: 2030-12-31
• First posted: 2023-12-18
• Last updated: 2025-12-04

Locations

2 sites across 1 country: Mexico

Regulatory

• FDA-regulated device study