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Visual Outcome After Vitrectomy With Subretinal tPA Injection

Visual Outcome After Vitrectomy With Subretinal tPA Injection to Treat Submacular Hemorrhage Secondary to Age-related Macular Degeneration or Macroaneurysm

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05196139
Acronym
EVA-tPA
Enrollment
96
Registered
2022-01-19
Start date
2021-04-01
Completion date
2021-08-16
Last updated
2022-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-Related Macular Degeneration

Brief summary

evaluate the safety of Eva surgical system

Detailed description

The purpose of this retrospective study is to evaluate the safety and clinical results using this surgical technique when performed using the EVA surgical system and associated instrumentation and disposable surgical equipment

Interventions

vitrectomy performed in case of submacular bleeding

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* patients with VTX subretinal tPA ( + phaco) * patients with submacular bleeding

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
pre-operative best corrected visual acuitypre surgery• The pre-operative BCVA will be taken from the visit when the indication for the surgery was set
Surgical adverse eventspostoperative visit on day 1Surgical adverse events or issues that were recorded in the surgical report
post-operative best corrected visual acuity6 weeks after surgeryThe post-operative BCVA will be taken from the latest visit after the surgical procedure

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026