Visual Outcome After Vitrectomy With Subretinal tPA Injection (EVA-tPA)

January 4, 2022 updated by: Universitaire Ziekenhuizen KU Leuven

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

evaluate the safety of Eva surgical system

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Surgery on the patients included in the study will have been performed using the EVA surgical system (DORC).

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
pre surgery
Surgical adverse events
Time Frame: postoperative visit on day 1
Surgical adverse events or issues that were recorded in the surgical report
postoperative visit on day 1
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
6 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

August 16, 2021

Study Completion (Actual)

August 16, 2021

Study Registration Dates

First Submitted

December 24, 2021

First Submitted That Met QC Criteria

January 4, 2022

First Posted (Actual)

January 19, 2022

Study Record Updates

Last Update Posted (Actual)

January 19, 2022

Last Update Submitted That Met QC Criteria

January 4, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 65203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Age-Related Macular Degeneration

Clinical Trials on retrospective study

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe