Study of Retinal Oxygenation in Central Retinal Vein Occlusion

Retinal Vein Occlusion Clinical Trial

Official title:

Multicenter Study of Retinal Oxygenation in Central Retinal Vein Occlusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02523339
• Other study ID #: UI-CRVO-2015
• Status: Completed
• Start date: October 2014
• Est. completion date: November 3, 2020

Study information

• Verified date: February 2021
• Source: University of Iceland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: November 3, 2020
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Retinal Vein Occlusion

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna
Czechia	Department of Ophthalmology, University Hospital and Faculty of Medicine and Dentistry, Palacky University Olomouc	Olomouc
Denmark	Aarhus University. Department of Clinical Medicine - The Department of Ophthalmology	Aarhus
Germany	University Hospital Jena	Jena
Iceland	University of Iceland / Landspitali, Dept. of Ophthalmology	Reykjavik
Switzerland	Eye Clinic of the University Hospital Basel	Basel	Basel-Stadt
Switzerland	Clinical Research Center Memorial A. de Rothschild	Geneva
United Kingdom	Aston University School of Life and Health Sciences	Birmingham

Sponsors (9)

Lead Sponsor	Collaborator
University of Iceland	Aston University, Clinical Research Center Memorial A. de Rothschild, Medical University of Vienna, Palacky University, University Hospital, Basel, Switzerland, University of Aarhus, University of Jena, University of Toyama

Countries where clinical trial is conducted

Austria,  Czechia,  Denmark,  Germany,  Iceland,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal vessel oxygen saturation		12 months
Primary	Visual acuity		12 months
Primary	Central retinal thickness		12 months
Primary	Presence or absence of ocular neovascularisation	As determined by gonioscopic examination	12 months
Secondary	Retinal vessel oxygen saturation		Baseline
Secondary	Visual acuity		Baseline
Secondary	Central retinal thickness		Baseline
Secondary	Presence or absence of ocular neovascularisation	As determined by gonioscopic examination	Baseline
Secondary	Retinal vessel oxygen saturation		3 months
Secondary	Visual acuity		3 months
Secondary	Central retinal thickness		3 months
Secondary	Presence or absence of ocular neovascularisation	As determined by gonioscopic examination	3 months
Secondary	Retinal vessel oxygen saturation		6 months
Secondary	Visual acuity		6 months
Secondary	Central retinal thickness		6 months
Secondary	Presence or absence of ocular neovascularisation	As determined by gonioscopic examination	6 months