Study of Retinal Oxygenation in Central Retinal Vein Occlusion

Multicenter Study of Retinal Oxygenation in Central Retinal Vein Occlusion

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.

Study Overview

• Status: Completed
• Conditions: Retinal Vein Occlusion

• Study Type: Observational
• Enrollment (Actual): 117

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Department of Clinical Pharmacology, Medical University of Vienna
• Czechia
  • Olomouc, Czechia, 77900
    • Department of Ophthalmology, University Hospital and Faculty of Medicine and Dentistry, Palacky University Olomouc
• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University. Department of Clinical Medicine - The Department of Ophthalmology
• Germany
  • Jena, Germany, 07743
    • University Hospital Jena
• Iceland
  • Reykjavik, Iceland, 101
    • University of Iceland / Landspitali, Dept. of Ophthalmology
• Switzerland
  • Geneva, Switzerland, 1208
    • Clinical Research Center Memorial A. de Rothschild
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4055
      • Eye Clinic of the University Hospital Basel
• United Kingdom
  • Birmingham, United Kingdom, B4 7ET
    • Aston University School of Life and Health Sciences

Participation Criteria

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 with suspected central retinal vein occlusion (CRVO) will be invited to participate.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retinal vessel oxygen saturation		12 months
Visual acuity		12 months
Central retinal thickness		12 months
Presence or absence of ocular neovascularisation	As determined by gonioscopic examination	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity		6 months
Retinal vessel oxygen saturation		Baseline
Visual acuity		Baseline
Central retinal thickness		Baseline
Presence or absence of ocular neovascularisation	As determined by gonioscopic examination	Baseline
Retinal vessel oxygen saturation		3 months
Visual acuity		3 months
Central retinal thickness		3 months
Presence or absence of ocular neovascularisation	As determined by gonioscopic examination	3 months
Retinal vessel oxygen saturation		6 months
Central retinal thickness		6 months
Presence or absence of ocular neovascularisation	As determined by gonioscopic examination	6 months

Collaborators and Investigators

• Sponsor: University of Iceland
• Collaborators: Medical University of Vienna; University Hospital, Basel, Switzerland; University of Aarhus; University of Jena; Palacky University; Aston University; Clinical Research Center Memorial A. de Rothschild; University of Toyama
• Investigators: Principal Investigator: Sveinn H. Hardarson, PhD, University of Iceland

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): November 3, 2020

Study Registration Dates

• First Submitted: August 7, 2015
• First Submitted That Met QC Criteria: August 11, 2015
• First Posted (Estimate): August 14, 2015

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Diseases; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Retinal Vein Occlusion
• Other Study ID Numbers: UI-CRVO-2015

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