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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06767917

Enrollment

148

Registered

2025-01-10

Start date

2024-11-26

Completion date

2026-03-25

Last updated

2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

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

Interventions

DEVICEEyefill® S.C.

Used as viscoelastic devices during cataract surgery

DEVICEEyefill® M.B.

Used as viscoelastic devices during cataract surgery

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026