NCT05196139

Brief Summary

evaluate the safety of Eva surgical system

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

5 months

First QC Date

December 24, 2021

Last Update Submit

January 4, 2022

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (3)

  • 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

Interventions

retrospective studyOTHER

vitrectomy performed in case of submacular bleeding

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Retrospective Studies

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Case-Control StudiesEpidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesCohort StudiesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Peter Stalmans, PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2021

First Posted

January 19, 2022

Study Start

April 1, 2021

Primary Completion

August 16, 2021

Study Completion

August 16, 2021

Last Updated

January 19, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)