Vitrectomy Retinal Oxygenation

June 25, 2020 updated by: Stefan Sacu

The Influence of Retinal Oxygenation on the Clinical Outcomes in Eyes With Different Vitreoretinal Pathologies After a Successful Vitrectomy

Vitrectomy is the common treatment for patients with macular edema secondary to epiretinal membrane. Recently, in eyes with diabetic macular edema or persistent macular edema following retinal vein occlusion, vitrectomy will be increasingly performed as an additional treatment modality. In eyes with impaired oxygen situation vitrectomy may improve the retinal oxygen saturation. However, little information is available about the oxygenation and the blood flow of the retinal vessels after vitroretinal surgery.

Hypoxia is a the major trigger of vascular endothelial growth factor (VEGF), which is in turn the most important factor for the development of macular edema. It is a major issue to improve the oxygen situation and the blood flow of the retina and there are just a few not satisfactory procedures available to overcome this problem. However, vitrectomy would be an adequate therapy for many of these diseases, and it would be an appreciated side effect of the treatment in almost every case.

To investigate the influence of oxygenation and blood flow of the retina on clinical outcomes after a successfully 23 gauge vitrectomy in eyes with epiretinal membrane, persistent macular edema following diabetic retinopathy or retinal vein occlusion.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

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, 1090
        • Department of Opthalmology/Clinical Pharmacology

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

Group 1: 20 patients with macular edema following epiretinal membrane Group 2: 20 patients with persistent diabetic macular edema. Group 3: 20 patients with persistent macular edema following retinal vein occlusion

Description

Inclusion Criteria:

  • male or female, at least 18 years of age.
  • ophthalmoscopic evidence of epiretinal membrane scheduled for vitrectomy and membrane peeling.
  • persistent diabetic macular edema
  • written informed consent
  • female patients of childbearing potential must have a negative urine pregnancy test.

Exclusion Criteria:

  • uncontrolled systemic disease
  • symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • any ocular condition that in the opinion of the investigator would be a contraindication for the surgical procedure
  • history of glaucoma, aphakie or presence of anterior chamber intraocular lens, choroidal neovascularisation, significant cataract, any ocular infection, - history of pars plana vitrectomy.
  • contraindication to pupil dilation.
  • need for silicon oil or gas after the surgery
  • advanced diabetic retinopathy with vitreoretinal tear and/or bleeding

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: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Epiretinal membrane
diabetic macular edema
vein occlusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Data
Time Frame: 6 months
Visus, OCT
6 months
Blood Flow Data
Time Frame: 6 months
Oxygenation of retinal blood vessles and retinal blood flow
6 months

Collaborators and Investigators

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

Sponsor

Stefan Sacu

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

October 1, 2011

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

January 11, 2012

First Submitted That Met QC Criteria

January 13, 2012

First Posted (Estimate)

January 16, 2012

Study Record Updates

Last Update Posted (Actual)

June 29, 2020

Last Update Submitted That Met QC Criteria

June 25, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VE-Oxygen-28062010

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.

Clinical Trials on Diabetic Macular Edema

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe