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

NCT ID: NCT03457584

Last Updated: 2020-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2019-12-01

Brief Summary

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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

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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.

Conditions

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Epiretinal Membrane

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BSS arm

BSS is given at the end of surgery

Group Type ACTIVE_COMPARATOR

BSS arm

Intervention Type PROCEDURE

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

air arm

air-tamponade is given at the end of surgery

Group Type EXPERIMENTAL

air arm

Intervention Type PROCEDURE

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

Interventions

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air arm

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

Intervention Type PROCEDURE

BSS arm

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* epiretinal membranes and intraretinal cystoid changes

Exclusion Criteria

* macular edema due to other reason than epiretinal membrane
* hereditary ocular disease
* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vienna Institute for Research in Ocular Surgery

OTHER

Sponsor Role lead

Responsible Party

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Prim. Prof. Dr. Oliver Findl, MBA

Prim. Prof. Dr. Oliver Findl, MBA

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oliver Findl, Prof

Role: PRINCIPAL_INVESTIGATOR

VIROS at Hanuschkrankenhaus Vienna

Locations

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

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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cysMP

Identifier Type: -

Identifier Source: org_study_id

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