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

RecruitingNAAges 18 Years - anyAllUniversity of Oxford
NCT07820761 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 t

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📋 Eligibility rules (as published)
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.
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What it tests

  • Surgery with Preceyes Robot plus NHS standard of care
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Where

1 site
Eye Research Group Oxford, Oxford Eye Hospital, LG1, West Wing of the John Radcliffe Hospital
Oxford, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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