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

NCT06767917 | Completed

• 1 other identifier: 931
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 2

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

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Mean change in corneal endothelial cell density between baseline and postoperative visits

  Assessed on Day 30 and Day 90

Other Outcomes (1)

• Safety outcome - Adverse event rate

  Assessed up to Day 90

Study Arms (2)

Eyefill® S.C.

EXPERIMENTAL

Device: Eyefill® S.C.

Eyefill® M.B.

EXPERIMENTAL

Device: Eyefill® M.B.

Interventions

Eyefill® S.C. DEVICE

Used as viscoelastic devices during cataract surgery

Eyefill® S.C.

Eyefill® M.B. DEVICE

Used as viscoelastic devices during cataract surgery

Eyefill® M.B.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch & Lomb GmbH: lead

Study Sites (2)

Site 102

Madrid, Madrid, 28040, Spain

Location

Site 103

Zaragoza, Spain, 50004, Spain

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 10, 2025
• Study Start: November 26, 2024
• Primary Completion: March 25, 2026
• Study Completion: March 25, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)