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OpenTrials
Completed

NCT Number: NCT05196139

Visual Outcome After Vitrectomy With Subretinal tPA Injection

evaluate the safety of Eva surgical system

Completed

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven

Leuven, 3000, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

retrospective study

Other

vitrectomy performed in case of submacular bleeding

Primary outcomes

  1. pre-operative best corrected visual acuity

    Time frame: pre surgery

    • The pre-operative BCVA will be taken from the visit when the indication for the surgery was set

  2. Surgical adverse events

    Time frame: postoperative visit on day 1

    Surgical adverse events or issues that were recorded in the surgical report

  3. post-operative best corrected visual acuity

    Time frame: 6 weeks after surgery

    The post-operative BCVA will be taken from the latest visit after the surgical procedure

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: EVA-tPA

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 19, 2022
Registry last updated
Jan 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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