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Robot arm steadies eye surgery for bleeding behind the retina

NCT ID NCT06347107

Disease control Sponsor: Universitaire Ziekenhuizen KU Leuven 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 robotic stabilizer to help surgeons inject a clot-busting drug (tPA) under the retina in 20 patients with bleeding from age-related macular degeneration. The robot held the needle steady for up to 3 minutes during standard surgery. The main goals were to see if the needle could be placed correctly and stay still, and to check for device-related side effects.

What this could mean

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

Active substance
tissue plasminogen activator (tPA)
What this could lead to
If successful, this robotic approach could make subretinal injections more precise and stable, potentially improving outcomes for people with bleeding under the retina.
What could go wrong
This was a small, early-stage study with only 20 participants and no control group. The device is a prototype, and results may not apply to all patients or settings.

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

20 people

The number who actually took part.

Started

Jun 2024

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures 2. Patients that are scheduled for vitrectomy surgery to treat a submacular hemorrhage with subretinal injection of tPA. 3. Both vitrectomy-only and combined phaco-vitrectomy surgeries 4. General anesthesia Exclusion Criteria: 1. Patients aged \< 18 years 2. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the study protocol. 3. Vitrectomy surgery for other indication than mentioned above 4. No post-operative week 8 visit is anticipated 5. General anesthesia not possible

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Conditions

The condition(s) this trial relates to.

age-related macular degeneration macular degeneration

As listed by the trial registrant

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

Age-related macular degeneration Subretinal hemorrhage

Contacts and locations

Locations

  • UZ Leuven

    Leuven, Vlaams-Brabant, 3000, Belgium

More trials for these conditions

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