Robotic Subretinal tPA Injection Study

NCT06347107 | Completed DMC

• 1 other identifier: S67215
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

In the RoTIS study, the investigators would like to test the robotic stabilizer for the subretinal injection of tPA in patients with subretinal hemorrhage during standard-of-care surgery. The surgical devices used during this procedure will be the following:

• The robotic stabilizer (prototype - FAMHP approval received)
• 41G subretinal needle (CE marked - used within label)
• Inicio micro-injection system (CE marked - used within label) The Inicio system mounted with the 41G needle will be held by the robot, and guided by the surgeon towards the required position. When the tip of the needle is in the desired subretinal position, the robotic stabilizer will be locked and the tPA will be injected till sufficient subretinal bleb formation is obtained, with a maximal duration of up to 3 minutes. As performed routinely, the surgical view through the microscope will be video-recorded and while the injection is being administered, the built-in iOCT of the Artevo surgical microscope (Zeiss, Oberkochen, Germany) will be used to scan the retina area around the injection site to record the subretinal bleb formation for later review.

Conditions

Subretinal Hemorrhage; Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

• Percentage of patients with succesful subretinal insertion of the robot-held 41G needle

  The insertion of a 41G subretinal needle adjacent to a subretinal hemorrhage using the stabilizing (tremor-reducing) properties of a robotic instrument will be evaluated. Succesful formation of a subretinal bleb will prove that the needle was introduced subretinally. This will be monitored visually through the operating microscope and with intra-operative OCT confirming the bleb formation.

  During surgery, once vitrectomy is completed, pass/fail event.

• Percentage of patients with stable subretinal position of the needle for at least 3 minutes.

  The ability to hold the needle still in the subretinal space for a time of up to 3 minutes after initiating bleb formation will be determined.This will be monitored visually through the operating microscope and with intra-operative OCT confirming the stable position of the needle.

  During surgery, immediately after insertion of the needle in the subretinal space for up to 3 minutes.

Secondary Outcomes (2)

• Device-related adverse events

  Duration of surgery: +/- 90 minutes

• Functional outcome

  2 months post-operative

Study Arms (1)

Robotic subretinal tPA injection group

EXPERIMENTAL

The purpose of this study is to determine the feasibility of subretinal injection of tPA assisted by a prototype robotic device.

Device: Robotic subretinal tPA injection

Interventions

Robotic subretinal tPA injection DEVICE

-The insertion of a 41G subretinal needle adjacent to a subretinal hemorrhage using the stabilizing (tremor-reducing) properties of a robotic instrument in order to slowly inject tPA and evaluate whether the needle can be held in place for up tot 3 minutes.

Robotic subretinal tPA injection group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
• Patients that are scheduled for vitrectomy surgery to treat a submacular hemorrhage with subretinal injection of tPA.
• Both vitrectomy-only and combined phaco-vitrectomy surgeries
• General anesthesia

You may not qualify if:

• Patients aged \< 18 years
• Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the study protocol.
• Vitrectomy surgery for other indication than mentioned above
• No post-operative week 8 visit is anticipated
• General anesthesia not possible

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• DORC Dutch Ophthalmic Research Center International BV: collaborator

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Peter Stalmans, MD PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Investigator-initiated, academic, mono-center, prospective, interventional case study

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 4, 2024
• Study Start: June 21, 2024
• Primary Completion: August 12, 2025
• Study Completion: August 12, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)