Eyefill gel devices pass safety check in cataract surgery study
NCT ID NCT06767917
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested two gel-like devices, Eyefill SC and Eyefill MB, used during cataract surgery to protect the eye. Researchers followed 148 adults who had cataract surgery with these devices to see if they were safe and worked as intended. The main focus was on changes in the eye's inner lining cells after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Eyefill SC and Eyefill MB (viscoelastic devices used during cataract surgery)
- What this could lead to
- If successful, this study confirms that these devices are safe and work well for protecting the eye during cataract surgery.
- What could go wrong
- This is a small, completed post-market study with no comparison group, so results may not apply to all patients or detect rare complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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148 people
The number who actually took part.
- Started
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Nov 2024
- Finished
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Mar 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Site 102
Madrid, Madrid, 28040, Spain
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Site 103
Zaragoza, Spain, 50004, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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