A Post-Market Clinical Follow-Up on Safety and Performance of the Ophthalmic Viscoelastic Devices Eyefill SC and Eyefill MB
NCT ID: NCT06767917
Last Updated: 2025-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2024-11-26
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Eyefill® S.C.
Eyefill® S.C.
Used as viscoelastic devices during cataract surgery
Eyefill® M.B.
Eyefill® M.B.
Used as viscoelastic devices during cataract surgery
Interventions
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Eyefill® S.C.
Used as viscoelastic devices during cataract surgery
Eyefill® M.B.
Used as viscoelastic devices during cataract surgery
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent;
* Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Bausch & Lomb GmbH
INDUSTRY
Responsible Party
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Locations
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Site 102
Madrid, , Spain
Site 103
Zaragoza, , Spain
Countries
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Central Contacts
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Other Identifiers
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931
Identifier Type: -
Identifier Source: org_study_id
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