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NCT03457584 Clinical Trial

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

Epiretinal Membrane Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03457584
Other study ID # cysMP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2017
Est. completion date December 1, 2019

Study information
Verified date September 2020
Source Vienna Institute for Research in Ocular Surgery
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 96
Est. completion date December 1, 2019
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- epiretinal membranes and intraretinal cystoid changes

Exclusion Criteria:

- macular edema due to other reason than epiretinal membrane

- hereditary ocular disease

- pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Austria VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital Vienna

Sponsors (1)
Lead Sponsor Collaborator
Vienna Institute for Research in Ocular Surgery

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary resorption of intraretinal cystoid changes after surgery occurrence of intraretinal cystoid changes will be diagnosed by OCT 3 months
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