CataractNCT06767917
A Post-Market Clinical Follow-Up on Safety and Performance of the Ophthalmic Viscoelastic Devices Eyefill SC and Eyefill MB
A study testing Eyefill® S.C. and Eyefill® M.B. in people with Cataract, run by Bausch & Lomb GmbH at 2 sites in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Eyefill® S.C. and Eyefill® M.B.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 2 sitesSpain
- Study dates
- 26 Nov 2024to 25 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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);
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- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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
- Conditions
- Cataract
- Being tested
- Eyefill® S.C., Eyefill® M.B.
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eyefill® S.C.Device
Used as viscoelastic devices during cataract surgery
Eyefill® M.B.Device
Used as viscoelastic devices during cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| Eyefill® S.C. | Experimental | Not described Receives: Device: Eyefill® S.C. |
| Eyefill® M.B. | Experimental | Not described Receives: Device: Eyefill® M.B. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in corneal endothelial cell density between baseline and postoperative visits
Measured: Assessed on Day 30 and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start26 Nov 2024
- Primary completion25 Mar 2026
- Study completion25 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767917
- Sponsor's protocol ID
- 931
- Status last verified
- Apr 2026
- First submitted
- 6 Jan 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of the Ophthalmic Viscoelastic Devices Eyefill SC and Eyefill MB - a Post-Market Clinical Follow-Up
- ClinicalTrials.gov ID
- NCT06767917
- Acronym / sponsor ID
- 931
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Bausch & Lomb GmbHIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- 25 Mar 2026 (actual)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eyefill® S.C. | Experimental | Device: Eyefill® S.C. |
| Eyefill® M.B. | Experimental | Device: Eyefill® M.B. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- Known hypersensitivity to sodium hyaluronate;
- Corneal endothelial cell density <1500 cells/mm2;
- Corneal abnormalities;
- Cataract density of grade 4+;
- Previous intraocular or corneal surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eyefill® S.C.Used as viscoelastic devices during cataract surgery | Device | Eyefill® S.C. |
| Eyefill® M.B.Used as viscoelastic devices during cataract surgery | Device | Eyefill® M.B. |
Primary outcome
Mean change in corneal endothelial cell density between baseline and postoperative visits
Time frame: Assessed on Day 30 and Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eyefill® S.C. and Eyefill® M.B. in people with Cataract, run by Bausch & Lomb GmbH at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in corneal endothelial cell density between baseline and postoperative visits (time frame: Assessed on Day 30 and Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.