NCT04306718

Brief Summary

ILM and ERM are routinely excised during surgery, as part of the surgical technique, and cultivation of hyalocytes will be performed ex vivo after surgery.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

October 1, 2019

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

June 4, 2024

Status Verified

June 1, 2024

Enrollment Period

4.8 years

First QC Date

October 21, 2019

Last Update Submit

June 2, 2024

Conditions

Epiretinal Membrane

Outcome Measures

Primary Outcomes (1)

  • Proliferation of Hyalocytes

    hyalocytes from ERM and ILM will be cultured and counted

    9 days

Study Arms (1)

studyarm

EXPERIMENTAL

Hyalocytes from ERM and ILM are cultured in alphaMEM to examine their proliferation habits

Procedure: membrane peeling

Interventions

membrane peelingPROCEDURE

ERM and ILM are peeled routinely during surgery

studyarm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Macular hole or epiretinal Membrane

You may not qualify if:

  • Pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VIROS at Hanuschkrankenhaus

Vienna, 1140, Austria

Location

Related Publications (1)

  • Chang WC, Lin C, Lee CH, Sung TL, Tung TH, Liu JH. Vitrectomy with or without internal limiting membrane peeling for idiopathic epiretinal membrane: A meta-analysis. PLoS One. 2017 Jun 16;12(6):e0179105. doi: 10.1371/journal.pone.0179105. eCollection 2017.

    PMID: 28622372BACKGROUND

MeSH Terms

Conditions

Epiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Oliver Findl, Prof., Dr.

    VIROS at Hanuschkrankenhaus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of department, Professor

Study Record Dates

First Submitted

October 21, 2019

First Posted

March 13, 2020

Study Start

October 1, 2019

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

June 4, 2024

Record last verified: 2024-06

Locations

AU(1)