Clinical Outcomes of the Gore Synthetic Cornea Device

NCT06174376 | Recruiting FDA Device

• 1 other identifier: GSC 23-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Artificial Corneal transplantation, corneal opacity, corneal blindness

Outcome Measures

Primary Outcomes (4)

• Primary Effectiveness: Device retention

  Number of study eyes with GORE Synthetic Cornea Device present

  Through 12 months

• Primary Safety: Intraoperative Adverse Events

  Number of subjects with procedure- and/or device-related adverse event during implant procedure

  At Initial Procedure

• Primary Safety: Post-operative ophthalmic Adverse Events

  Number of subjects with post-operative ophthalmic adverse event in the study eye

  Through 12 months

• Primary Safety: Secondary surgical Intervention

  Number of subjects requiring post-operative secondary surgical interventions (SSIs)

  Through 12 months

Secondary Outcomes (1)

• Secondary Effectiveness: Improvement in Visual Acuity

  Through 12 month

Study Arms (1)

GORE Synthetic Cornea Device

EXPERIMENTAL

Treatment with GORE Synthetic Cornea Device

Device: GORE Synthetic Cornea Device

Interventions

GORE Synthetic Cornea Device DEVICE

Treatment with GORE Synthetic Cornea Device

GORE Synthetic Cornea Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must meet all of the following criteria to be eligible to be consented for this study.
• 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.
• Male or female patients ≥ 18 years old at the time of consent
• 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.)
• 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
• Best corrected distance visual acuity of worse than 20/400 in the study eye using Snellen chart
• Best corrected distance visual acuity of better than 20/200 in the fellow (non-study) eye using Snellen chart
• Pseudophakia status in the study eye with a stable posterior chamber intraocular lens (IOL) implant centered within the capsular bag or sulcus
• 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)
• If applicable, prior corneal transplant ≥ 8 mm in diameter
• Adequate lid function and normal ocular surface and tear film parameters for implant of the study device, as determined by the investigator.

You may not qualify if:

• Inability to provide written informed consent and comply with study assessments for the full duration of the study.
• Age: \< 18 years
• 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.
• 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
• If applicable, prior corneal transplant \< 8 mm in diameter
• Aphakic or phakic status of the study eye
• Pseudophakic status of the study eye with anterior chamber IOL or unstable posterior chamber IOL, according to clinical history or UBM
• 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
• Evidence of conjunctival or lid margin keratinization
• Presence of cicatrizing conjunctivitis (Stevens Johnson Syndrome, mucous membrane pemphigoid, trachoma, chemical, radiation or thermal trauma
• Prior history of stage II or III neurotrophic keratitis / keratopathy
• Limbal stem cell deficiency leading to prior episode(s) of recurrent or persistent corneal epithelial defects
• Prior history of immune-mediated/ non-infectious keratolysis with or without underlying systemic disease

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (2)

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

Mexico City, Mexico

NOT YET RECRUITING

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

Mexico City, Mexico

RECRUITING

Related Publications (1)

• Ramirez-Miranda A, Ortiz-Morales G, Domene-Hickman JL, Fabregas-Sanchez-Woodworth D, Garcia-Padilla L, Navas A, Akpek EK, Graue-Hernandez EO. Surgical Considerations for the Human Implantation of the Gore Synthetic Corneal Device. Cornea. 2025 Nov 1;44(11):1426-1430. doi: 10.1097/ICO.0000000000003950. Epub 2025 Aug 14.

  PMID: 40810416 DERIVED

MeSH Terms

Conditions

Corneal Opacity

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Arturo Ramirez Miranda, MD

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

  PRINCIPAL INVESTIGATOR

• Valeria Sanchez Huerta, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anuraag Singh

CONTACT

410-506-7560; asingh@wlgore.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 18, 2023
• Study Start: August 19, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2)