Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 47 of 81 for:    CRVO - Central Retinal Vein Occlusion

Study of Retinal Oxygenation in Central Retinal Vein Occlusion

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.
ClinicalTrials.gov Identifier: NCT02523339
Recruitment Status : Active, not recruiting
First Posted : August 14, 2015
Last Update Posted : July 11, 2018
Sponsor:
Collaborators:
University Hospital, Basel, Switzerland
Aston University
University of Jena
Medical University of Vienna
University of Aarhus
Clinical Research Center Memorial A. de Rothschild
Palacky University
University of Toyama
Information provided by (Responsible Party):
Sveinn Hakon Hardarson, University of Iceland

Brief Summary:
The purpose of the study is to test if oxygen saturation in retinal vessels is correlated with clinical parameters, such as visual acuity, central retinal thickness and presence of neovascularization. Retinal oximetry is performed with fundus camera based oximeters. The study will not entail change in treatment of the disease.

Condition or disease
Retinal Vein Occlusion

Layout table for study information
Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Study of Retinal Oxygenation in Central Retinal Vein Occlusion
Study Start Date : October 2014
Actual Primary Completion Date : June 2018
Estimated Study Completion Date : December 31, 2018



Primary Outcome Measures :
  1. Retinal vessel oxygen saturation [ Time Frame: 12 months ]
  2. Visual acuity [ Time Frame: 12 months ]
  3. Central retinal thickness [ Time Frame: 12 months ]
  4. Presence or absence of ocular neovascularisation [ Time Frame: 12 months ]
    As determined by gonioscopic examination


Secondary Outcome Measures :
  1. Retinal vessel oxygen saturation [ Time Frame: Baseline ]
  2. Visual acuity [ Time Frame: Baseline ]
  3. Central retinal thickness [ Time Frame: Baseline ]
  4. Presence or absence of ocular neovascularisation [ Time Frame: Baseline ]
    As determined by gonioscopic examination

  5. Retinal vessel oxygen saturation [ Time Frame: 3 months ]
  6. Visual acuity [ Time Frame: 3 months ]
  7. Central retinal thickness [ Time Frame: 3 months ]
  8. Presence or absence of ocular neovascularisation [ Time Frame: 3 months ]
    As determined by gonioscopic examination

  9. Retinal vessel oxygen saturation [ Time Frame: 6 months ]
  10. Visual acuity [ Time Frame: 6 months ]
  11. Central retinal thickness [ Time Frame: 6 months ]
  12. Presence or absence of ocular neovascularisation [ Time Frame: 6 months ]
    As determined by gonioscopic examination



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with suspected central retinal vein occlusion (CRVO) will be invited to participate.
Criteria

Inclusion Criteria:

  • Suspected central retinal vein occlusion.
  • Informed consent for participation.
  • No treatment before the first oximetry measurement.

Exclusion Criteria:

  • History of other retinal disease. Glaucoma and diabetes without retinopathy are not exclusion criteria but should be registered.
  • History of cardiovascular or respiratory diseases that can be expected to influence systemic or retinal oxygen saturation. Examples: Known COPD or carotid stenosis. Subjects with high blood pressure will not be excluded but blood pressure should be registered.
  • Poor quality images will be excluded based on the images themselves. Therefore, grading of cataract or other media opacities is not strictly necessary for the purpose of the study.

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): NCT02523339


Locations
Layout table for location information
Austria
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria, 1090
Czechia
Department of Ophthalmology, University Hospital and Faculty of Medicine and Dentistry, Palacky University Olomouc
Olomouc, Czechia, 77900
Denmark
Aarhus University. Department of Clinical Medicine - The Department of Ophthalmology
Aarhus, Denmark, 8000
Germany
University Hospital Jena
Jena, Germany, 07743
Iceland
University of Iceland / Landspitali, Dept. of Ophthalmology
Reykjavik, Iceland, 101
Switzerland
Eye Clinic of the University Hospital Basel
Basel, Basel-Stadt, Switzerland, 4055
Clinical Research Center Memorial A. de Rothschild
Geneva, Switzerland, 1208
United Kingdom
Aston University School of Life and Health Sciences
Birmingham, United Kingdom, B4 7ET
Sponsors and Collaborators
University of Iceland
University Hospital, Basel, Switzerland
Aston University
University of Jena
Medical University of Vienna
University of Aarhus
Clinical Research Center Memorial A. de Rothschild
Palacky University
University of Toyama
Investigators
Layout table for investigator information
Principal Investigator: Sveinn H. Hardarson, PhD University of Iceland

Layout table for additonal information
Responsible Party: Sveinn Hakon Hardarson, Post-doctoral researcher, University of Iceland
ClinicalTrials.gov Identifier: NCT02523339     History of Changes
Other Study ID Numbers: UI-CRVO-2015
First Posted: August 14, 2015    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Layout table for MeSH terms
Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases