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Clinical Outcomes of the Gore Synthetic Cornea Device | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT06174376•W.L.Gore & Associates

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must meet all of the following criteria to be eligible to be consented for this study.
•1. Patient must be able to comprehend the study requirements and provide written informed consent. Patients must be willing to follow study instructions, agree to comply with all study procedures , and able to return for all scheduled follow-up examinations for 12 months postoperatively (the study duration). The follow-up exams may be extended up to 60 months post operatively if the patient consents to the extension.
•2. Male or female patients ≥ 18 years old at the time of consent
•3. Physical condition suitable for undergoing surgery, as evidenced by medical history and physical examination provided by a licensed medical provider (primary care physician, nurse practitioner, internal medicine physician etc.)
•4. Currently with an opaque cornea (as determined by the investigator) with or without a prior history of failed donor corneal transplantation \[penetrating keratoplasty (PK) or endothelial keratoplasty (EK)\] and loss of corneal clarity
•5. Best corrected distance visual acuity of worse than 20/400 in the study eye using Snellen chart
•6. Best corrected distance visual acuity of better than 20/200 in the fellow (non-study) eye using Snellen chart
•7. Pseudophakia status in the study eye with a stable posterior chamber intraocular lens (IOL) implant centered within the capsular bag or sulcus
•8. Corneal thickness measurement in study eye (epithelium to endothelium; central and mid-peripheral/ 3 to 5mm away from center at superior, inferior, nasal and temporal quadrants) with each measurement between 700um - 900um, measured using ultrasound (US) pachymetry. If one or more measurements cannot be obtained using US pachymetry, measurements using anterior segment optical coherence tomography (OCT) may be used (with the measurement being between 700-900um)
•9. If applicable, prior corneal transplant ≥ 8 mm in diameter
+1 more criteria

Exclusion Criteria

•1. Inability to provide written informed consent and comply with study assessments for the full duration of the study.
•2. Age: \< 18 years
•3. Patients who are pregnant/nursing or planning to become pregnant during the study.
•Note: For women of child-bearing potential, confirmation of pregnancy status must be documented per site standard.
•4. Corneal thickness measurement (epithelium to endothelium; central and mid-peripheral/ 3 to 5mm away from center at superior, inferior, nasal and temporal quadrants) in the study eye with any measurement less than 700um or more than 900um measured using US pachymetry. If one or more measurements cannot be obtained using US pachymetry, measurements using anterior segment OCT may be used
•5. If applicable, prior corneal transplant \< 8 mm in diameter
•6. Aphakic or phakic status of the study eye
•7. Pseudophakic status of the study eye with anterior chamber IOL or unstable posterior chamber IOL, according to clinical history or UBM
•8. Evidence of tear film, ocular surface or lid abnormalities in the study eye
•* Schirmer test without anesthesia less than 5 mm at 5 minutes. NOTE: Patient can be eligible after successful tear duct blockage (such as plugs or cauterization) if the Schirmer's are adequate following the procedure
+35 more criteria

Locations (2)

Asociación para Evitar la Ceguera en México, I.A.P

Mexico City, Mexico

Instituto de Oftalmología Fundación de Asistencia Privada Conde Valenciana I.A. P.

Mexico City, Mexico

Key Dates

Start Date

August 19, 2024

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2030

Last Updated

December 4, 2025

Enrollment

ESTIMATED participants

Conditions

Corneal Opacity

Interventions

GORE Synthetic Cornea Device

DEVICE

Contacts

Anuraag Singh

CONTACT

410-506-7560 asingh@wlgore.com

OCT in Diagnosis of Irregular Corneas

NCT03504800

KeratoconusCorneal Opacity+1 more

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RECRUITINGNA

Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy

NCT01243931

Corneal Opacity

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SUSPENDEDNA

Study to Evaluate the Clinical Safety and Performance of the CorNeat KPro for Treatment of Corneal Blindness

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Outcomes of the Gore Synthetic Cornea Device

Inclusion Criteria

Exclusion Criteria

OCT in Diagnosis of Irregular Corneas

Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy

Study to Evaluate the Clinical Safety and Performance of the CorNeat KPro for Treatment of Corneal Blindness

OCT-guided LALAK for KCN

Topical Anesthesia for Closed PKP vs Retrobulbar Anesthesia for Open-sky PKP

Laser Assisted Procedures in Penetrating Keratoplasty