Actively Recruiting
Clinical Outcomes of the Gore Synthetic Cornea Device
Led by W.L.Gore & Associates · Updated on 2025-12-04
10
Participants Needed
2
Research Sites
332 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Clinical Outcomes of the Gore Synthetic Cornea Device
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand study requirements and provide written informed consent
- Willing to follow study instructions and attend all follow-up exams for 12 months (with possible extension to 60 months)
- Male or female 18 years or older
- Suitable physical condition for surgery as confirmed by a licensed medical provider
- Currently have an opaque cornea with or without prior failed donor corneal transplantation and loss of corneal clarity
- Best corrected distance visual acuity worse than 20/400 in the study eye
- Best corrected distance visual acuity better than 20/200 in the fellow (non-study) eye
- Pseudophakia status in the study eye with stable posterior chamber intraocular lens implant
- Corneal thickness in study eye between 700um and 900um measured by ultrasound pachymetry or anterior segment OCT
- Prior corneal transplant 8 mm or larger in diameter if applicable
- Adequate lid function and normal ocular surface and tear film parameters for device implant
You will not qualify if you...
- Unable to provide written informed consent or comply with study assessments for full study duration
- Under 18 years old
- Pregnant, nursing, or planning pregnancy during study
- Corneal thickness in study eye less than 700um or greater than 900um measured by ultrasound pachymetry or anterior segment OCT
- Prior corneal transplant less than 8 mm in diameter if applicable
- Aphakic or phakic status in the study eye
- Pseudophakic status with anterior chamber intraocular lens or unstable posterior chamber intraocular lens
- Tear film, ocular surface, or lid abnormalities such as low Schirmer test, keratinization, cicatrizing conjunctivitis, neurotrophic keratitis, limbal stem cell deficiency, immune-mediated keratolysis, significant lid margin disease or anatomical lid problems
- Current or recent (within 30 days) corneal or ocular surface infection
- Known intolerance or allergy to study medications or device components
- History of ocular or periocular malignancy within 5 years
- History of herpes simplex or varicella-zoster keratitis
- Shingles vaccination within past year or planned during study
- History of uveitis, scleritis, or retinitis in study eye
- Uncontrolled glaucoma or hypotony in study eye
- Significant anterior synechia or corneal stromal vascularization
- Recent retinal detachment or silicone oil in posterior segment
- Prior keratoprosthesis device implantation
- Monocular status
- Unable to wear soft contact lens due to conjunctival or lid abnormalities
- Signs of current systemic infection
- Participation in another interventional trial affecting study outcomes
- Severe diseases or conditions affecting study results
- History of substance abuse or psychiatric disorder affecting study adherence
- Unable to comply with study procedures and follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Asociación para Evitar la Ceguera en México, I.A.P
Mexico City, Mexico
Not Yet Recruiting
2
Instituto de Oftalmología Fundación de Asistencia Privada Conde Valenciana I.A. P.
Mexico City, Mexico
Actively Recruiting
Research Team
A
Anuraag Singh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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