Evaluating the safety and performance of Eyefill viscoelastic devices for cataract surgery

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

This study is testing how safe and effective new Eyefill viscoelastic devices are for adults undergoing cataract surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bausch & Lomb Incorporated (Industry-sponsored)
• Locations: 2 sites (Madrid and 1 other locations)
• Trial ID: NCT06767917 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective, non-comparative follow-up to assess the safety and performance of Eyefill® S.C. and Eyefill® M.B., which are viscoelastic devices used during cataract surgery. The study involves adult patients who are scheduled for cataract surgery with the implantation of a posterior chamber intraocular lens. Participants will be monitored for their compliance with examination procedures and the outcomes related to the use of these devices in surgery.

Who should consider this trial

Good fit: Ideal candidates for this study are adults scheduled for cataract surgery who can provide informed consent and comply with examination procedures.

Not a fit: Patients with known hypersensitivity to sodium hyaluronate, significant corneal abnormalities, or other serious ocular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the safety and effectiveness of cataract surgery, leading to better patient outcomes.

How similar studies have performed: While this study focuses on specific viscoelastic devices, similar studies evaluating the safety and performance of ophthalmic devices have shown promising results.

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.

Where this trial is running

Madrid and 1 other locations

• Site 102 — Madrid, Spain (Recruiting)
• Site 103 — Zaragoza, Spain (Recruiting)

Study contacts

• Study coordinator: Daniel Sagan

Conditions Cataract