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NCT05196139 Clinical Trial

Visual Outcome After Vitrectomy With Subretinal tPA Injection

Age-Related Macular Degeneration Clinical Trial

— EVA-tPA  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05196139
Other study ID # 65203
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date August 16, 2021

Study information
Verified date January 2022
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

evaluate the safety of Eva surgical system

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

Recruitment information / eligibility
Status Completed
Enrollment 96
Est. completion date August 16, 2021
Est. primary completion date August 16, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients with VTX subretinal tPA ( + phaco) - patients with submacular bleeding Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• retrospective study
vitrectomy performed in case of submacular bleeding

Locations
Country Name City State
Belgium UZ Leuven Leuven

Sponsors (1)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary pre-operative best corrected visual acuity • The pre-operative BCVA will be taken from the visit when the indication for the surgery was set pre surgery
Primary Surgical adverse events Surgical adverse events or issues that were recorded in the surgical report postoperative visit on day 1
Primary post-operative best corrected visual acuity The post-operative BCVA will be taken from the latest visit after the surgical procedure 6 weeks after surgery
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