Intraretinal Cystoid Changes After Vitrectomy With Membrane Peeling

September 28, 2020 updated by: Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
Aim of the study is to assess the rate of postoperative intraretinal cystoid changes after pars plana vitrectomy with membrane peeling and peribulbar application of triamcinolone acetonide and to examine possible risk factors for postoperative intraretinal cystoid changes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Epiretinal membranes (ERM) are disorders leading to vision loss and metamorphopsia. Vitrectomy with membrane peeling has developed to be the gold-standard in treatment of ERM. Nevertheless, there are about 10% of patients having intraretinal cystoid changes after surgery with potential for disturbance of visual acuity. The aim of the study is to assess the rate of postoperative intraretinal cystoid changes after pars plana vitrectomy with membrane peeling and peribulbar application of triamcinolone acetonide and to examine possible risk factors for postoperative intraretinal cystoid changes.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1140
        • Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients having undergone pars plana vitrectomy with membrane peeling and periocular application of triamcinolone acetonide at the end of surgery between June 2019 and January 2020 at the department of Ophthalmology of the Hanusch Hospital in Vienna, Austria, were selected for the study

Description

Inclusion Criteria:

  • presence of an ERM
  • indication for membrane peeling defined as significant loss of vision and/or metamorphopsia due to the ERM
  • application of periocular triamcinolone acetonide at the end of surgery
  • at least one follow-up examination present in the patient's history

Exclusion Criteria:

  • macular edema caused by conditions other than ERM (such as choroidal neovascularization, diabetic macular edema, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Studygroup
Retrospective analysis of OCT, IOP and distance corrected visual acuity from the patients history.
Device: optical coherence tomography (OCT)
OCT visualizes the retinal layers by backreflection of light

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraretinal cystoid changes
Time Frame: 3 months
presence of intraretinal cystoid changes in OCT is assessed during the time period of 3 months after surgery
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraocular pressure (IOP)
Time Frame: 3 months
intraocular pressure is examined during the time period of 3 months after surgery
3 months
distance corrected visual acuity
Time Frame: 3 months
distance corrected visual acuity is measured at baseline and 3 months after surgery
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vienna Institute for Research in Ocular Surgery

Investigators

  • Principal Investigator: Oliver Findl, Prof., Vienna Institute for Research in Ocular Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2020

Primary Completion (Actual)

September 28, 2020

Study Completion (Actual)

September 28, 2020

Study Registration Dates

First Submitted

July 11, 2020

First Submitted That Met QC Criteria

July 11, 2020

First Posted (Actual)

July 15, 2020

Study Record Updates

Last Update Posted (Actual)

September 29, 2020

Last Update Submitted That Met QC Criteria

September 28, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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