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

April 30, 2026 updated by: Bausch & Lomb GmbH

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Madrid, Madrid, Spain, 28040
        • Site 102
    • Spain
      • Zaragoza, Spain, Spain, 50004
        • Site 103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eyefill® S.C.
Device: Eyefill® S.C.
Used as viscoelastic devices during cataract surgery
Experimental: Eyefill® M.B.
Device: Eyefill® M.B.
Used as viscoelastic devices during cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in corneal endothelial cell density between baseline and postoperative visits
Time Frame: Assessed on Day 30 and Day 90
Assessed on Day 30 and Day 90

Other Outcome Measures

Outcome Measure
Time Frame
Safety outcome - Adverse event rate
Time Frame: Assessed up to Day 90
Assessed up to Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2024

Primary Completion (Actual)

March 25, 2026

Study Completion (Actual)

March 25, 2026

Study Registration Dates

First Submitted

January 6, 2025

First Submitted That Met QC Criteria

January 6, 2025

First Posted (Actual)

January 10, 2025

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 931

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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