A Post-Market Clinical Follow-Up on Safety and Performance of the Ophthalmic Viscoelastic Devices Eyefill SC and Eyefill MB
Not Applicable
Recruiting
- Conditions
- Cataract
- Registration Number
- NCT06767917
- Lead Sponsor
- Bausch & Lomb GmbH
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mean change in corneal endothelial cell density between baseline and postoperative visits Assessed on Day 30 and Day 90
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular interactions between Eyefill SC/MB viscoelastic agents and corneal endothelial cells influence intraocular pressure stability during cataract surgery?
How does the safety profile of Eyefill SC/MB compare to sodium hyaluronate-based viscoelastic devices in posterior capsule preservation during phacoemulsification?
Which biomarkers correlate with corneal endothelial cell density preservation after Eyefill viscoelastic device use in dense cataract surgery?
What are the incidence rates of intraoperative miosis and posterior capsule rupture with Eyefill SC/MB versus standard viscoelastic agents in NCT06767917?
How do Eyefill SC/MB viscoelastic properties compare to Alcon Healon or Johnson & Johnson Viscoat in managing capsular bag stability during cataract extraction?
Trial Locations
- Locations (2)
Site 103
🇪🇸Zaragoza, Spain
Site 102
🇪🇸Madrid, Spain