Robotic RVO Trial: Robot-assisted Retinal Vein Cannulation in Patients With Retinal Vein Occlusions

NCT07820761 — Not applicable, Recruiting, 40 participants, University of Oxford

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Evaluating the Safety and Efficacy of Robot-assisted Retinal Vein Cannulation in Patients With Retinal Vein Occlusions.

Registry	NCT07820761, acronym RVO
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, other
Enrollment	40 (Estimated)
Sponsor	University of Oxford (Other)
Conditions	Retinal Vein Occlusion (RVO)
Interventions	Surgery with Preceyes Robot plus NHS standard of care (Procedure)
Dates	start 2025-09-01, primary completion 2027-03-30 (estimated), completion 2028-03-30 (estimated), first posted 2026-09-15, last updated 2026-10-21
Locations	1 site in United Kingdom

-Summary

Retinal vein occlusions (RVOs) are the second leading cause of permanent vision loss in the UK. Current treatments, like anti-VEGF injections or steroids, address complications such as macular fluid but do not target the underlying issue-a clot in the retinal vein. Direct injection of clot-dissolving agents, such as tissue plasminogen activator (tPA), is challenging due to the small size of retinal veins. This surgical trial aims to inject tPA directly into the blocked retinal vein to dissolve the clot and restore blood flow.

This surgical trial aims to inject tPA directly into the blocked retinal vein to dissolve the clot and restore blood flow. Robotic assistance will stabilise the injection cannula, ensuring precise and slow infusion of tPA. This study will compare outcomes in patients receiving standard care for RVOs (the control group) with those receiving standard treatment plus the robot-assisted tPA injection (the study group). The robotic system has been clinically validated and has received CE marking for vitreoretinal interventions, including tPA injection beneath the retina.

tPA has been safely used in the eye with no reported safety concerns. It is licensed for intravenous use for thromboembolic events that lead to ischemia. RVO (an ischemic stroke of the eye) is a specific example. Instead of systemic administration through the peripheral vein, we will be directly delivering tPA into the occluded retinal vein, effectively treating the localised ischemia, within licensed intent.

40 eligible participants diagnosed with RVO will be recruited from the NHS clinic. Participants will be randomly allocated to the control group or the study group and will be monitored for 12 months. The study focuses on safety as the primary outcome and efficacy in terms of retinal structure and function as secondary outcomes. If successful, this trial could lead to a new intervention for RVO-related vision loss.

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+Arms and interventions

Arm	Type	Interventions	Description
Control Arm ( NHS Standard of Care Surgery)	No intervention		Participants randomised to the control arm will receive NHS standard of care surgery.
Interventional Arm ( NHS Standard of Care Surgery + Robot)	Active comparator	Procedure: Surgery with Preceyes Robot plus NHS standard of care	Participants randomised to the interventional arm will receive robot-assisted vein cannulation and infusion into the blocked vein during the NHS standard of care surgery.

Surgery with Preceyes Robot plus NHS standard of care (Procedure): Central Retinal Vein cannulation and infusion into the blocked vein using the Preceyes Robot, while following NHS standard of care

+Outcome measures

Primary outcomes

Safety of robot-assisted retinal vein cannulation [Baseline to 12 months]: Evaluation of safety will be based on the potential number of procedure-related adverse events.

Secondary outcomes

To evaluate change in visual acuity [Baseline to 12 months]: Mean change from baseline to Month 12 in Best-Corrected Visual Acuity (BCVA) as measured by the Early Treatment of Diabetic Retinopathy (ETDRS) Chart
To evaluate change in central macular thickness [Baseline to 12 months]: Mean change in central macular thickness from baseline to Month 12 as measured with spectral domain optical coherence tomography ( SD-OCT)
To evaluate changes in area of the non-perfused retina [At all protocol-specified visits with the endpoint at 12 months.]: Change in area of the non-perfused retina from baseline to Month 12 as measured with fundus fluorescein angiography (FFA).

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Participant is wiling and able to give informed consent for participation in the trial
* Male or Female aged 18 years or above
* Recently diagnosed with central RVO (<4 weeks)
* In the Investigator's opinion, the patient is able and willing to comply with all trial requirements and is deemed fit for treatment.
* ETDRS BCVA letter score of 70 or less or Snellen equivalent (< 6/12) in the study eye at Screening Visit 1

Exclusion Criteria:

* Participants with comorbidities contraindicating vitreoretinal surgery (e.g. excessive tremor) as determined by the investigator.
* Participants with ocular comorbidities contraindicating the use of steroid implants (e.g. glaucoma) or anti-VEGFs as determined by the investigator.
* Participants who are participating in another research trial involving an investigational product or surgical intervention.
* Participants with known allergy to Fluorescein
* Participants with contraindications for the use of tPA (Alteplase, Boehringer Ingelheim, Germany) or currently receiving or starting medications that have a known interaction with tPA, as identified in the SmPC, which may alter its efficacy or safety profile of tPA.

+Locations (1)

Facility	City	Country	Status
Eye Research Group Oxford, Oxford Eye Hospital, LG1, West Wing of the John Radcliffe Hospital	Oxford, Oxfordshire	United Kingdom	Recruiting