Visual Outcome After Vitrectomy With Subretinal tPA Injec... | NCT05196139

Studies
Visual Outcome After Vitrectomy With Subretinal tPA Injection

NCT05196139

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Last Update Posted

Jan 19, 2022Actual

Enrollment

96Actual

Phase

Not provided

Conditions

Age-Related Macular Degeneration

Interventions

retrospective study

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2021Actual

Primary Completion Date

Aug 16, 2021Actual

Completion Date

Aug 16, 2021Actual

First Submitted Date

Dec 24, 2021

First Submission Date that Met QC Criteria

Jan 4, 2022

First Posted Date

Jan 19, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2022

Last Update Posted Date

Jan 19, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

96Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
retrospective study	Other	vitrectomy performed in case of submacular bleeding

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
Surgical adverse events	Surgical adverse events or issues that were recorded in the surgical report	postoperative visit on day 1
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Stalmans, PhD	UZ Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ Leuven		Leuven		3000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Jun 21, 2022
Unrelease	Jun 21, 2022
Release	Jun 22, 2022
Reset	Apr 3, 2023
Release	Apr 4, 2023
Reset	Jan 11, 2024

Submission Tracking

Estimated Results First Submitted Date

Jun 21, 2022

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jun 21, 2022	Jun 21, 2022
Jun 22, 2022

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012189	Retrospective Studies

Ancestor Terms

ID	Term
D016022	Case-Control Studies
D016021	Epidemiologic Studies
D016020	Epidemiologic Study Characteristics
D004812	Epidemiologic Methods

Browse Leaves

Not provided

Browse Branches

Not provided