Overview
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
Eligibility
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.