Effect of Air-tamponade on Intraretinal Cystoid Changes A... | NCT03457584

Studies
Effect of Air-tamponade on Intraretinal Cystoid Changes After Membrane Peeling

NCT03457584

Sponsor

Vienna Institute for Research in Ocular Surgery

Status

Completed

Last Update Posted

Sep 29, 2020Actual

Enrollment

96Actual

Phase

Not Applicable

Conditions

Epiretinal Membrane

Interventions

air arm
BSS arm

Countries

Austria

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

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

Nov 1, 2017Actual

Primary Completion Date

Dec 1, 2019Actual

Completion Date

Dec 1, 2019Actual

First Submitted Date

Mar 1, 2018

First Submission Date that Met QC Criteria

Mar 1, 2018

First Posted Date

Mar 7, 2018Actual

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

Sep 28, 2020

Last Update Posted Date

Sep 29, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prim. Prof. Dr. Oliver Findl, MBA, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular SurgeryPrincipal Investigator

Lead Sponsor

Vienna Institute for Research in Ocular SurgeryOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

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.

Detailed Description

Patients with intraretinal cystoid changes before scheduled membrane peeling for epiretinal membranes are included. 23G-pars plana vitrectomy with membrane peeling is performed in all patients. Before surgery patients are randomized for BSS or air-tamponade. Optical coherence tomography (OCT) is performed 5 days after and 3 months after surgery, visual acuity is measured 3 months after surgery.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
air arm	Procedure	epiretinal membranes are excised during membrane peeling and air-tamponade is left in the eye	air arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
resorption of intraretinal cystoid changes after surgery	occurrence of intraretinal cystoid changes will be diagnosed by OCT	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

epiretinal membranes and intraretinal cystoid changes

Exclusion Criteria:

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

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Oliver Findl, Prof	VIROS at Hanuschkrankenhaus Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital		Vienna		1140	Austria

Condition Browse Module

MeSH Terms

ID	Term
D019773	Epiretinal Membrane

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided