A Post-Market Clinical Follow-Up on Safety and Performance of the Ophthalmic Viscoelastic Devices Eyefill SC and Eyefill MB

Exclusion Criteria

• •Known hypersensitivity to sodium hyaluronate;
• •Corneal endothelial cell density \<1500 cells/mm2;
• •Corneal abnormalities;
• •Cataract density of grade 4+;
• •Previous intraocular or corneal surgery;
• •Chronic or recurrent inflammatory eye diseases (e.g., iritis, scleritis, iridocyclitis, or rubeosis iridis);
• •Clinically significant, uncontrolled glaucoma with expected negative impact on visual acuity outcomes;
• •Ongoing systemic or ocular steroid therapy;
• •Diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity loss to 20/30 or worse in one or both eyes;
• •Active ocular or systemic infection (bacterial, viral, or fungal), including fever
• •Subjects who may be expected to require a combined or other secondary surgical procedure
• •Females of childbearing potential (those who are not surgically sterilized or not postmenopausal for at least 12 months) if they meet one of the following conditions: Pregnant, lactating or unwilling to use effective birth control over the course of the study;
• •Concurrent or previous (within 30 days) participation in another drug or device investigation.