Study of Retinal Oxygenation in Central Retinal Vein Occlusion

Completed

• Conditions: Retinal Vein Occlusion

• Registration Number: NCT02523339
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-08-07
• Study First Submitted QC: 2015-08-11
• Study First Posted: 2015-08-14
• Primary Completion: 2018-06
• Study Completion: 2020-11-03
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-11
• Last Update Posted: 2021-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Retinal vessel oxygen saturation	12 months
Central retinal thickness	12 months
Visual acuity	12 months
Presence or absence of ocular neovascularisation	12 months	As determined by gonioscopic examination

Secondary Outcome Measures

Name	Time	Method
Presence or absence of ocular neovascularisation	6 months	As determined by gonioscopic examination
Central retinal thickness	6 months
Visual acuity	6 months
Retinal vessel oxygen saturation	6 months

Trial Locations

Locations (8)

Department of Clinical Pharmacology, Medical University of Vienna; 🇦🇹 Vienna, Austria

Aston University School of Life and Health Sciences; 🇬🇧 Birmingham, United Kingdom

Eye Clinic of the University Hospital Basel; 🇨🇭 Basel, Basel-Stadt, Switzerland

Department of Ophthalmology, University Hospital and Faculty of Medicine and Dentistry, Palacky University Olomouc; 🇨🇿 Olomouc, Czechia

Aarhus University. Department of Clinical Medicine - The Department of Ophthalmology; 🇩🇰 Aarhus, Denmark

University Hospital Jena; 🇩🇪 Jena, Germany

University of Iceland / Landspitali, Dept. of Ophthalmology; 🇮🇸 Reykjavik, Iceland

Clinical Research Center Memorial A. de Rothschild; 🇨🇭 Geneva, Switzerland