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

Launched by BAUSCH & LOMB GMBH · Jan 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of two special devices called Eyefill® S.C. and Eyefill® M.B., which are used during cataract surgery. Cataracts are a common eye condition where the lens of the eye becomes cloudy, leading to vision problems. The goal of the study is to see how well these devices work in helping doctors perform the surgery safely.

To participate in this trial, adults aged 65 and older who are scheduled for cataract surgery may be eligible, as long as they can give their consent and follow the study procedures. However, certain conditions may exclude individuals, such as having previous eye surgeries, certain eye diseases, or ongoing infections. Participants can expect to be monitored closely throughout the study to ensure their safety and to gather important information about how these devices perform during surgery. This trial is currently recruiting participants, and it’s a great opportunity to contribute to research that may improve cataract surgery outcomes in the future.

Gender

ALL

Eligibility criteria

• 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.