Last updated 7 months ago
Clinical Outcomes of the Gore Synthetic Cornea Device
10 patients around the world
Available in Mexico
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).
W.L.Gore & Associates
1Research sites
10Patients around the world
This study is for people with
Corneal Opacity
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 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.Currently with an opaque cornea with or without a prior history of failed donor corneal transplantation 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 implant centered within the capsular bag or sulcus.Corneal thickness measurement in study eye with each measurement between 700um - 900um, measured using ultrasound pachymetry.If one or more measurements cannot be obtained using ultrasound pachymetry, measurements using anterior segment optical coherence tomography may be used.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.
- 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.For women of child-bearing potential, confirmation of pregnancy status must be documented per site standard.Corneal thickness measurement in the study eye with any measurement less than 700um or more than 900um measured using ultrasound pachymetry.If one or more measurements cannot be obtained using ultrasound pachymetry, measurements using anterior segment optical coherence tomography 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 intraocular lens or unstable posterior chamber intraocular lens, 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.Patient can be eligible after successful tear duct blockage if the Schirmer's are adequate following the procedure.Evidence of conjunctival or lid margin keratinization.Presence of cicatrizing conjunctivitis.Prior history of stage II or III neurotrophic keratitis.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.Patient can be eligible after successful treatment and resolution.Significant anatomical lid problems.Current or history of corneal or ocular surface infection in the study eye within 30 days prior to surgery.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.History of ocular or periocular malignancy in the study eye within the previous five years.Current or prior history of herpes simplex virus or Varicella-zoster virus 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.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.3 contiguous clock hours of synechia.Involving the central 8 mm of the cornea.Presence of significant corneal stromal vascularization.Retinal detachment within 30 days prior to surgery.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 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.
Sites
APEC - Hospital de la Ceguera
SponsorW.L.Gore & Associates
Conditions
Corneal Opacity
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06174376
