Surgical Considerations for the Human Implantation of the Gore Synthetic Corneal Device.
Arturo Ramirez-Miranda, Gustavo Ortiz-Morales, Jorge L Domene-Hickman...
https://pubmed.ncbi.nlm.nih.gov/40810416Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06174376
A Prospective, Multi-Center, Early Feasibility Study to Assess Clinical Outcomes of the GORE Synthetic Cornea Device in Patients With Loss of Corneal Clarity
Led by W.L.Gore & Associates · Updated on 2025-12-04
10
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the initial safety and effectiveness of the GORE Synthetic Cornea Device in treating loss of corneal clarity in patients who need corneal transplantation. This early feasibility study is prospective, open-label, single-arm, and conducted across multiple centers. It aims to assess clinical outcomes in patients with corneal opacity who are candidates for this procedure. Participants will receive treatment with the GORE Synthetic Cornea Device. After the procedure, they will have scheduled clinical follow-up visits over a 12-month study period to monitor their progress and device performance. The study may extend follow-up examinations up to 60 months if patients agree to continue. During the study, participants will undergo evaluations including visual acuity tests and assessments for adverse events related to the device and surgery. Researchers will track device retention, surgical complications, and any need for secondary interventions. Safety and effectiveness outcomes will be monitored through regular clinical exams, with the primary measures focused on safety events at the initial procedure and during the 12 months after treatment.
CONDITIONS
Brief Title
Clinical Outcomes of the Gore Synthetic Cornea Device
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Ability to understand study requirements and provide written informed consent
- Willingness to follow study instructions and comply with all procedures
- Availability to return for scheduled follow-up visits for 12 months postoperatively
- Male or female patients aged 18 years or older
- Physical condition suitable for surgery as confirmed by a licensed medical provider
- Presence of an opaque cornea with or without prior failed donor corneal transplantation
- 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 eye
- Pseudophakia status in the study eye with stable posterior chamber intraocular lens implant
- Corneal thickness in study eye between 700 and 900 micrometers measured by ultrasound pachymetry or anterior segment OCT
- Prior corneal transplant diameter of 8 mm or greater if applicable
- Adequate lid function and normal ocular surface and tear film parameters for device implant
You will not qualify if you...
- Inability to provide informed consent or comply with study assessments
- Age less than 18 years
- Pregnancy, nursing, or planning pregnancy during the study
- Corneal thickness less than 700 or greater than 900 micrometers in the study eye
- Prior corneal transplant diameter less than 8 mm if applicable
- Aphakic or phakic status of the study eye
- Pseudophakic status with anterior chamber intraocular lens or unstable posterior chamber lens
- Tear film, ocular surface, or lid abnormalities including low Schirmer test
- Recent corneal or ocular surface infection within 30 days prior to surgery
- Known intolerance or allergy to study medications or device components
- History of ocular or periocular malignancy within past five years
- History of herpes simplex or varicella-zoster keratitis in the study eye
- Recent shingles vaccination or plans to receive during study
- History of uveitis, scleritis, or retinitis in the study eye
- Uncontrolled glaucoma or hypotony in the study eye
- Presence of broad anterior synechia or significant corneal stromal vascularization
- Recent retinal detachment or current silicone oil in posterior segment
- Previous keratoprosthesis device implantation
- Monocular status
- Inability to wear soft contact lens due to abnormalities
- Signs of systemic infection within two weeks prior to surgery
- Participation in another interventional trial affecting outcomes
- Severe diseases or conditions affecting study results
- History of substance abuse, psychiatric disorders affecting adherence
- Inability to comply with study procedures and follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Day of procedure
Participants undergo implantation of the GORE Synthetic Cornea Device as treatment for loss of corneal clarity.
1 procedure visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Up to 1 week post-procedure
Participants receive clinical follow-up immediately after the device implantation to monitor safety and early outcomes.
Several visits within the first week after surgery (in-person)
Post-operative Follow-up
Duration - Up to 12 months
Participants attend scheduled clinical follow-up visits to assess device retention, visual acuity improvement, and monitor for adverse events.
Regular visits over 12 months (in-person)
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
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Research Team
A
Anuraag Singh
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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