Visual Outcome After Vitrectomy With Subretinal tPA Injection

Completed

• Conditions: Age-Related Macular Degeneration

• Registration Number: NCT05196139
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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

Study Timeline

• Study Start: 2021-04-01
• Primary Completion: 2021-08-16
• Study Completion: 2021-08-16
• Study First Submitted: 2021-12-24
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-04
• Last Update Submitted: 2022-01-04
• Study First Posted: 2022-01-19
• Last Update Posted: 2022-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium