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

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

Prospective, Non-comparative, Post Market Clinical Follow Up Study to demonstrate safety and performance of Eyefill® S.C. and Eyefill® M.B. as viscoelastic devices for cataract surgery

Inclusion Criteria:

• Adult subjects scheduled for cataract surgery with im-plantation of a posterior chamber intraocular lens;
• Signed informed consent;
• Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures

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.