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OpenTrials
Completed

NCT Number: NCT03457584

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Vienna, 1140, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • epiretinal membranes and intraretinal cystoid changes

Exclusion criteria

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

Treatment and study plan

air arm

Procedure

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

BSS arm

Procedure

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

Primary outcomes

  1. resorption of intraretinal cystoid changes after surgery

    Time frame: 3 months

    occurrence of intraretinal cystoid changes will be diagnosed by OCT

Sponsors and collaborators

Lead sponsor

Vienna Institute for Research in Ocular Surgery

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 7, 2018
Registry last updated
Sep 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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