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

Bausch & Lomb GmbH

Status

Enrolling

Conditions

Cataract

Treatments

Device: Eyefill® S.C.

Device: Eyefill® M.B.

Study type

Interventional

Funder types

Industry

Identifiers

NCT06767917

931

Details and patient eligibility

About

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

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.