Robotic injection of tPA for treating subretinal hemorrhage
Robotic Subretinal tPA Injection Study
This study is testing if using a robotic device to help inject a medication under the retina can improve vision for people with bleeding in the eye due to age-related macular degeneration.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT06347107 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the use of a robotic stabilizer for the subretinal injection of tPA in patients undergoing vitrectomy surgery for submacular hemorrhage. The procedure involves using a 41G subretinal needle and an Inicio micro-injection system, both of which are CE marked, to deliver tPA precisely under the retina. The robotic device will assist the surgeon in positioning the needle accurately, and the injection will be monitored using advanced imaging techniques. The goal is to improve visual outcomes for patients suffering from complications of age-related macular degeneration.
Who should consider this trial
Good fit: Ideal candidates for this study are patients scheduled for vitrectomy surgery to treat submacular hemorrhage who can provide informed consent.
Not a fit: Patients under 18 years old or those requiring vitrectomy for indications other than submacular hemorrhage may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness of treating subretinal hemorrhage and improve visual acuity in affected patients.
How similar studies have performed: While the use of robotic assistance in surgical procedures is gaining traction, this specific application for subretinal tPA injection is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Leuven, Vlaams-Brabant
- UZ Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
Study contacts
- Principal investigator: Peter Stalmans, MD PhD — UZ Leuven
- Study coordinator: Peter Stalmans, MD PhD
- Email: peter.stalmans@uzleuven.be
- Phone: 016340768
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.