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CompletedNCT03457584Updated Sep 29, 2020

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

An interventional study of air arm and BSS arm in Epiretinal Membrane, sponsored by Vienna Institute for Research in Ocular Surgery. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-29.

Sponsored by Vienna Institute for Research in Ocular Surgery · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Nov 2017, registered Mar 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Epiretinal Membrane by Vienna Institute for Research in Ocular Surgery — 1 open to participants now, 2 under way, none of them phase 3. Epiretinal Membrane · Vienna Institute for Research in Ocular Surgery.

Started
2017
with 1 other
No phase
8 of 10
1 open now
Registered
4th of 10
by date

Among the 10 studies in Epiretinal Membrane by Vienna Institute for Research in Ocular Surgery, this one is one of 2 that started in 2017, is one of 8 with no phase, and was the 4th registered.

Epiretinal Membrane

130 studies on the registry are indexed under Epiretinal Membrane; 18 are open to participants now.

Browse Epiretinal Membrane studies →

Open to participants now

1 of the 10 studies in Epiretinal Membrane by Vienna Institute for Research in Ocular Surgery is open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

Where they have run

Who these studies take

Of the 11 Epiretinal Membrane studies recruiting now, 9 (82%) set no upper age limit and none (0%) stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Epiretinal Membrane

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • epiretinal membranes and intraretinal cystoid changes

Exclusion criteria

Exclusion Criteria:

  • macular edema due to other reason than epiretinal membrane
  • hereditary ocular disease
  • pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
96 participants (actual)

Study arms

  • Active comparator
    BSS arm

    BSS is given at the end of surgery

    Procedure: BSS arm

  • Experimental
    air arm

    air-tamponade is given at the end of surgery

    Procedure: air arm

Interventions

  • Procedureair arm

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

  • ProcedureBSS arm

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

06

What researchers measure

Primary outcomes

  1. resorption of intraretinal cystoid changes after surgery

    occurrence of intraretinal cystoid changes will be diagnosed by OCT

    Time frame: 3 months

07

Study locations

1 site
  • VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital
    Vienna, 1140, Austria
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2017 to primary completion in Dec 2019, 25 months.

Of 30 interventional studies with no phase under Epiretinal Membrane, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 90. This study's 25 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 1, 2018
First posted
Mar 7, 2018
StartActual
Nov 1, 2017
Primary completionActual
Dec 1, 2019
CompletionActual
Dec 1, 2019
Last update
Sep 29, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03457584
Lead sponsor
Vienna Institute for Research in Ocular Surgery
Responsible party
Prim. Prof. Dr. Oliver Findl, MBA (Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery) — Principal investigator
First posted
Mar 7, 2018
Start date
Nov 1, 2017
Primary completion
Dec 1, 2019
Completion
Dec 1, 2019
Last update
Sep 29, 2020

Study contacts

Oliver Findl, Prof
principal investigator · VIROS at Hanuschkrankenhaus Vienna

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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