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Vitrectomy Retinal Oxygenation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01510691
First Posted: January 16, 2012
Last Update Posted: April 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stefan Sacu, Medical University of Vienna
  Purpose

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.


Condition
Diabetic Macular Edema

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Influence of Retinal Oxygenation on the Clinical Outcomes in Eyes With Different Vitreoretinal Pathologies After a Successful Vitrectomy

Resource links provided by NLM:


Further study details as provided by Stefan Sacu, Medical University of Vienna:

Primary Outcome Measures:
  • Clinical Data [ Time Frame: 6 months ]
    Visus, OCT

  • Blood Flow Data [ Time Frame: 6 months ]
    Oxygenation of retinal blood vessles and retinal blood flow


Estimated Enrollment: 7
Study Start Date: October 2011
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Epiretinal membrane
diabetic macular edema
vein occlusion

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01510691


Locations
Austria
Department of Opthalmology/Clinical Pharmacology
Vienna, Austria, 1090
Sponsors and Collaborators
Stefan Sacu
  More Information

Responsible Party: Stefan Sacu, Ass Prof Priv Doz Dr, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01510691     History of Changes
Other Study ID Numbers: VE-Oxygen-28062010
First Submitted: January 11, 2012
First Posted: January 16, 2012
Last Update Posted: April 15, 2015
Last Verified: April 2015

Keywords provided by Stefan Sacu, Medical University of Vienna:
Oxygenation of the retinal vessels
vitroretinal surgery

Additional relevant MeSH terms:
Macular Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases