Clinical Outcomes of the Gore Synthetic Cornea Device
ConditionCorneal Opacity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorW.L.Gore & Associates
About this trial
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
Eligibility criteria
Qualifiers
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.)
Disqualifiers
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.
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
Trial design
Treatments tested in this trial
- GORE Synthetic Cornea Device
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov