Pivotal Trial for a Synthetic Tissue Substitute for Concealment of Artificial Ocular Implants

Exclusion Criteria

• •1. Current retinal detachment
• •2. Active ocular or orbital infection
• •3. History or evidence of severe inflammatory eye diseases (i.e. uveitis, retinitis, scleritis) in one or both eyes within 6 months prior to planned implantation
• •4. History of ocular or periocular malignancy
• •5. History of extensive keloid formation
• •6. Any known intolerance or hypersensitivity to topical anesthetics, mydriatics, or component of the device, specifically Oxybuprocaine hydrochloride, lidocaine, tropicamide, epinephrine, Iodine solution \& aromatic polycarbonate urethane
• •7. Signs of current infection, including fever and current treatment with antibiotics
• •8. Severe generalized disease that results in a life expectancy shorter than a year
• •9. Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device
• •10. Pregnant or breastfeeding female subjects
• •11. Participation in any study involving an investigational drug or device within 30 days of the study or 5 half-lives of the drug (whichever longer) or ongoing participation in a study with an investigational drug or device
• •12. Any traumatic perforation of the globe OR tissue gaps/weaknesses, resulting either from traumatic, disease- related or iatrogenic damage OR loss of scleral integrity where use of tissue or substitutes is indicated
• •13. Vulnerable populations
• •14. Active drug or alcohol abuse or dependence that, in the opinion of the principle investigator, would interfere with adherence to study requirements
• •15. Subjects with other concurrent severe and/or uncontrolled medical condition which could compromise participation in the study (e.g. active infection, uncontrolled diabetes, uncontrolled hypertension, congestive heart failure, unstable angina, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months, uncompensated cirrhosis, active upper GI tract ulceration, active inflammatory disease, malignancy under active treatment)
• •16. Subjects who receive anti-coagulation treatment which cannot be interfered during the perioperative period
• •17. Hemoglobin A1C (HbA1c) higher than 8% at screening indicating unbalanced diabetes and/or target organ damage associated with diabetes
• •18. Subjects receiving chronic systemic immunosuppressants (e.g. steroids, cyclosporine etc.)