Status:

RECRUITING

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

Lead Sponsor:

Bausch & Lomb GmbH

Conditions:

Cataract

Eligibility:

All Genders

18+ years

Phase:

NA

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

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.

Key Trial Info

Start Date :

November 26 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2026

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT06767917

Start Date

November 26 2024

End Date

January 1 2026

Last Update

June 24 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Site 102

Madrid, Spain, 28040

2

Site 103

Zaragoza, Spain, 50004