NCT03457584

Brief Summary

Patients with intraretinal cystoid changes before scheduled membrane peeling for epiretinal membranes are included. Patients are randomized for balanced salt solution (BSS) or air-tamponade.

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 not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

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

November 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

2.1 years

First QC Date

March 1, 2018

Last Update Submit

September 28, 2020

Conditions

Epiretinal Membrane

Outcome Measures

Primary Outcomes (1)

  • resorption of intraretinal cystoid changes after surgery

    occurrence of intraretinal cystoid changes will be diagnosed by OCT

    3 months

Study Arms (2)

BSS arm

ACTIVE COMPARATOR

BSS is given at the end of surgery

Procedure: BSS arm

air arm

EXPERIMENTAL

air-tamponade is given at the end of surgery

Procedure: air arm

Interventions

air armPROCEDURE

epiretinal membranes are excised during membrane peeling and air-tamponade is left in the eye

air arm
BSS armPROCEDURE

epiretinal membranes are excised during membrane Peeling and BSS is left in the eye

BSS arm

Eligibility Criteria

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

You may qualify if:

  • epiretinal membranes and intraretinal cystoid changes

You may not qualify if:

  • macular edema due to other reason than epiretinal membrane
  • hereditary ocular disease
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital

Vienna, 1140, Austria

Location

MeSH Terms

Conditions

Epiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Oliver Findl, Prof

    VIROS at Hanuschkrankenhaus Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prim. Prof. Dr. Oliver Findl, MBA

Study Record Dates

First Submitted

March 1, 2018

First Posted

March 7, 2018

Study Start

November 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

September 29, 2020

Record last verified: 2020-09

Locations

AU(1)