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

Sponsor
Vienna Institute for Research in Ocular Surgery (Other)
Overall Status
Completed
CT.gov ID
NCT03457584
Collaborator
(none)
96
1
2
25
3.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: air arm
  • Procedure: BSS arm
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Air-tamponade on Intraretinal Cystoid Changes After Vitrectomy With Membrane Peeling
Actual Study Start Date :
Nov 1, 2017
Actual Primary Completion Date :
Dec 1, 2019
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: BSS arm

BSS is given at the end of surgery

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

Experimental: air arm

air-tamponade is given at the end of surgery

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

Outcome Measures

Primary Outcome Measures

  1. resorption of intraretinal cystoid changes after surgery [3 months]

    occurrence of intraretinal cystoid changes will be diagnosed by OCT

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • epiretinal membranes and intraretinal cystoid changes
Exclusion Criteria:
  • macular edema due to other reason than epiretinal membrane

  • hereditary ocular disease

  • pregnancy

Contacts and Locations

Locations

Site City State Country Postal Code
1 VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital Vienna Austria 1140

Sponsors and Collaborators

  • Vienna Institute for Research in Ocular Surgery

Investigators

  • Principal Investigator: Oliver Findl, Prof, VIROS at Hanuschkrankenhaus Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prim. Prof. Dr. Oliver Findl, MBA, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier:
NCT03457584
Other Study ID Numbers:
  • cysMP
First Posted:
Mar 7, 2018
Last Update Posted:
Sep 29, 2020
Last Verified:
Sep 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 29, 2020