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Eyefill gel devices pass safety check in cataract surgery study

NCT ID NCT06767917

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

148 people

The number who actually took part.

Started

Nov 2024

Finished

Mar 2026

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Site 102

    Madrid, Madrid, 28040, Spain

  • Site 103

    Zaragoza, Spain, 50004, Spain

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