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Clinical Outcomes of the Gore Synthetic Cornea Device

NCT06174376 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-12-04

No results posted yet for this study

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

Conditions

  • Corneal Opacity

Interventions

DEVICE

GORE Synthetic Cornea Device

Treatment with GORE Synthetic Cornea Device

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • Arturo Ramirez Miranda, MD · Instituto de Oftalmología Fundación de Asistencia Privada Conde Valenciana I.A. P.

  • Valeria Sanchez Huerta, MD · Asociación para Evitar la Ceguera en México, I.A.P

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-19
Primary Completion
2026-12-31
Completion
2030-12-31
FDA Device
Yes

Countries

  • Mexico

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 NCT06174376 on ClinicalTrials.gov