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New eye gel passes safety test in cataract and glaucoma surgeries

NCT ID NCT07184437

Disease control Sponsor: Bohus Biotech AB Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a gel called MINIVISC® PLUS, used during eye surgeries like cataract removal and glaucoma surgery to protect delicate tissues and keep the eye stable. Researchers checked if the gel was safe and worked well in 134 patients. The main focus was on eye pressure after surgery and signs of inflammation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MINIVISC® PLUS gel (a fermented ophthalmic viscosurgical device)
What this could lead to
If successful, this gel could be a safe and effective tool to protect the eye and maintain space during various eye surgeries.
What could go wrong
This is a completed study with results not yet published. The gel is already in use, so this trial mainly confirms its safety and performance rather than introducing a breakthrough.

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

134 people

The number who actually took part.

Started

Feb 2024

Finished

Jul 2025

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

19 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: 1. Male or Female, \>18 years, in need of ophthalmic surgery for: * Cataract * Glaucoma surgery * Anterior segment trauma or diseases * Damaged or diseased cornea 2. Able and willing to give informed consent for participation in the investigation. 3. For the participation in Phase A of the study, patients that need surgery on one or both eyes will be included. For the participation in Phase B of the study, patients that need surgery on one or both eyes will be included but only one eye can be included in the clinical investigation. Exclusion Criteria: 1. Pregnant or lactating females. 2. Any previous hypersensitivity reaction to any constituent of the IMD. 3. Concurrent participation or participation within 45 days prior to preoperative visit in any other clinical trial. 4. Recent ocular trauma or ocular surgery that is not resolved/stable or may affect clinical outcomes or increase risk to the subject. 5. Ocular hypertension of ≥22 mmHg, after 3 repeated measurements pre-surgery. 6. An endothelial cell count (ECC) lower than 1800 cells/mm2 preoperatively, based on the average of the three cell counts as taken by the Specular Microscope (only in Phase A). 7. Any other condition or treatment making the subject unsuitable for participation in the clinical investigation, as judged by the Principal Investigator, including but not exclusive to diagnosis of wide-angle glaucoma, severe myopia, uveitis, and physical traits such as a small pupil, an extremely shallow anterior chamber, or a compromised endothelial cell function. 8. Employees of the study site or the sponsor directly involved with the conduct of the investigation, or immediate family members of any such individuals.

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Conditions

The condition(s) this trial relates to.

cataract corneal disorder glaucoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cataract

Contacts and locations

Locations

  • Eye Clinic Falu Hosptal

    Falun, Dalarna County, 791 82, Sweden

  • Optalmic Clinic Uddevalla Hospital

    Uddevalla, Västra Götaland County, 451 53, Sweden

  • Optalmica Eye Clinic

    Stockholm, Stockholm County, 183 34, Sweden

  • Opthalmic Clinic University Hospital Linköping

    Linköping, Östergötland County, 581 85, Sweden

  • UZ Leuven

    Leuven, 3000, Belgium

  • Ögonläkargruppen Odenplan

    Stockholm, Stockholm County, 113 22, Sweden

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