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Corneal OpacityNCT06174376

Clinical Outcomes of the Gore Synthetic Cornea Device

A study testing GORE Synthetic Cornea Device in people with Corneal Opacity, run by W.L.Gore & Associates at 2 sites in Mexico.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Corneal Opacity
What is being tested?
GORE Synthetic Cornea Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesMexico
Study dates
19 Aug 2024to 31 Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • Patients who meet any of the following exclusion criteria cannot be consented and included in this study:
  • 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
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  • 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
  • Significant lid margin disease with infestation/infection within 30 days prior to surgery.
  • NOTE: Patient can be eligible after successful treatment and resolution
  • Significant anatomical lid problems (trichiasis, entropion, ectropion, lagophthalmos, exophthalmos, Bell's palsy, or significant ptosis)
  • Current or history of corneal or ocular surface infection in the study eye within 30 days prior to surgery.
  • NOTE: Patient can be eligible after successful treatment and resolution as determined by the investigator
  • Any known intolerance or hypersensitivity to topical anesthetics, mydriatics, post-operative antibiotic or steroid drops , topical intraocular pressure lowering drops, allergy to sulfa drugs, or inability to tolerate oral intraocular pressure lowering drugs, or any component of the device
  • History of ocular or periocular malignancy in the study eye within the previous five years
  • Current or prior history of herpes simplex virus (HSV) or Varicella-zoster virus (VZV) keratitis in the study eye.
  • History of shingles vaccination in the past year or intent to receive the vaccine during the study period
  • Current or prior history of uveitis in the study eye
  • Current or prior history of scleritis or retinitis in the study eye
  • Uncontrolled glaucoma defined by having one or both of the below:
  • Intraocular pressure of greater than 21 mm Hg
  • Intraocular pressure above the specific target pressure for the patient NOTE: Patients with history of glaucoma who are on topical glaucoma medications or who have undergone glaucoma surgery with intraocular pressure within the target range are eligible
  • Hypotony in the study eye, as evidenced by an intraocular pressure of < 6 mmHg
  • Presence of broad anterior synechia greater than a quadrant, defined by having both of the below:
  • 3 contiguous clock hours of synechia
  • Involving the central 8 mm of the cornea
  • Presence of significant corneal stromal vascularization, defined by having both of the below:
  • 3 contiguous clock hours of vascularization
  • Involving the central 8 mm of the cornea
  • Retinal detachment within 30 days prior to surgery. NOTE: Patients with a prior history of retinal detachment surgery are eligible, unless they currently have silicone oil in the posterior segment
  • Current (or prior) history of other keratoprosthesis device implantation
  • Monocular status
  • Inability to wear a soft contact lens due to conjunctival or lid abnormalities
  • Signs of current (within the two weeks prior to surgery) systemic infection, including fever and current treatment with antibiotics
  • Participation in another simultaneous interventional medical investigation or trial that may have a reasonable likelihood of affecting the outcomes of the present study
  • Have any other history of clinically severe diseases, or conditions that in the opinion of the investigator, may affect the results of the study
  • Any current or history of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication or adherence to study procedures
  • Patients who are unable to comply with the study procedures and follow-up visits throughout the study period (12 months)

Trial locations and contacts

2 sites in 1 country.

Mexico2 sites

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

    Mexico City

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

    Mexico City

Other trials in Mexico

About this study

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

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

Read the 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
Being tested
GORE Synthetic Cornea Device
Keywords
Artificial Corneal transplantation, corneal opacity, corneal blindness
Medical subject headings
Corneal Opacity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GORE Synthetic Cornea DeviceDevice

    Treatment with GORE Synthetic Cornea Device

Study groups in NCT06174376
Study groupRoleWhat they receive
GORE Synthetic Cornea DeviceExperimentalTreatment with GORE Synthetic Cornea Device
Receives: Device: GORE Synthetic Cornea Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Effectiveness: Device retention

    Number of study eyes with GORE Synthetic Cornea Device present

    Measured: Through 12 months

  2. Primary Safety: Intraoperative Adverse Events

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

    Measured: At Initial Procedure

  3. Primary Safety: Post-operative ophthalmic Adverse Events

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

    Measured: Through 12 months

  4. Primary Safety: Secondary surgical Intervention

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

    Measured: Through 12 months

Secondary outcomes (1)

  1. Secondary Effectiveness: Improvement in Visual Acuity

    Number of study eyes with improvement of two lines or more in Best Spectacle Corrected Distance Visual Actuity compared to pre-operative baseline

    Measured: Through 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2023
  2. Study start19 Aug 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06174376
Sponsor's protocol ID
GSC 23-01
Status last verified
Jul 2026
First submitted
8 Dec 2023
Last updated
16 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 40810416

Questions about this trial

What is this clinical trial studying?

A study testing GORE Synthetic Cornea Device in people with Corneal Opacity, run by W.L.Gore & Associates at 2 sites in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Effectiveness: Device retention (time frame: Through 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06174376, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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