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

Primary Purpose

Epiretinal Membrane

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
air arm
BSS arm
Sponsored by
Vienna Institute for Research in Ocular Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epiretinal Membrane

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • epiretinal membranes and intraretinal cystoid changes

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

BSS arm

air arm

Arm Description

BSS is given at the end of surgery

air-tamponade is given at the end of surgery

Outcomes

Primary Outcome Measures

resorption of intraretinal cystoid changes after surgery
occurrence of intraretinal cystoid changes will be diagnosed by OCT

Secondary Outcome Measures

Full Information

First Posted
March 1, 2018
Last Updated
September 28, 2020
Sponsor
Vienna Institute for Research in Ocular Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT03457584
Brief Title
Effect of Air-tamponade on Intraretinal Cystoid Changes After Membrane Peeling
Official Title
Effect of Air-tamponade on Intraretinal Cystoid Changes After Vitrectomy With Membrane Peeling
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vienna Institute for Research in Ocular Surgery

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiretinal Membrane

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BSS arm
Arm Type
Active Comparator
Arm Description
BSS is given at the end of surgery
Arm Title
air arm
Arm Type
Experimental
Arm Description
air-tamponade is given at the end of surgery
Intervention Type
Procedure
Intervention Name(s)
air arm
Intervention Description
epiretinal membranes are excised during membrane peeling and air-tamponade is left in the eye
Intervention Type
Procedure
Intervention Name(s)
BSS arm
Intervention Description
epiretinal membranes are excised during membrane Peeling and BSS is left in the eye
Primary Outcome Measure Information:
Title
resorption of intraretinal cystoid changes after surgery
Description
occurrence of intraretinal cystoid changes will be diagnosed by OCT
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, Prof
Organizational Affiliation
VIROS at Hanuschkrankenhaus Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital
City
Vienna
ZIP/Postal Code
1140
Country
Austria

12. IPD Sharing Statement

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

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