Clinical trial NCT02523339: Study of Retinal Oxygenation in Central Retinal Vein Occlusion
Official title: Multicenter Study of Retinal Oxygenation in Central Retinal Vein Occlusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Vein Occlusion
Lead sponsor: University of Iceland
Sponsor class: OTHER
Collaborators: name: University Hospital, Basel, Switzerland
name: Aston University
name: University of Jena
name: Medical University of Vienna
name: University of Aarhus
name: Clinical Research Center Memorial A. de Rothschild
name: Palacky University
name: University of Toyama
First posted: 2015-08-14
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected central retinal vein occlusion (CRVO) will be invited to participate.

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.


Eligibility 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.

Primary outcomes:
measure: Retinal vessel oxygen saturation
timeFrame: 12 months
measure: Visual acuity
timeFrame: 12 months
measure: Central retinal thickness
timeFrame: 12 months
measure: Presence or absence of ocular neovascularisation
timeFrame: 12 months
Secondary outcomes:
measure: Retinal vessel oxygen saturation
timeFrame: Baseline
measure: Visual acuity
timeFrame: Baseline
measure: Central retinal thickness
timeFrame: Baseline
measure: Presence or absence of ocular neovascularisation
timeFrame: Baseline
measure: Retinal vessel oxygen saturation
timeFrame: 3 months
measure: Visual acuity
timeFrame: 3 months
measure: Central retinal thickness
timeFrame: 3 months
measure: Presence or absence of ocular neovascularisation
timeFrame: 3 months
measure: Retinal vessel oxygen saturation
timeFrame: 6 months
measure: Visual acuity
timeFrame: 6 months
measure: Central retinal thickness
timeFrame: 6 months
measure: Presence or absence of ocular neovascularisation
timeFrame: 6 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
city: Olomouc
country: Czechia
facility: Department of Ophthalmology, University Hospital and Faculty of Medicine and Dentistry, Palacky University Olomouc
city: Aarhus
country: Denmark
facility: Aarhus University. Department of Clinical Medicine - The Department of Ophthalmology
city: Jena
country: Germany
facility: University Hospital Jena
city: Reykjavik
country: Iceland
facility: University of Iceland / Landspitali, Dept. of Ophthalmology
city: Basel
country: Switzerland
facility: Eye Clinic of the University Hospital Basel
state: Basel-Stadt
city: Geneva
country: Switzerland
facility: Clinical Research Center Memorial A. de Rothschild
city: Birmingham
country: United Kingdom
facility: Aston University School of Life and Health Sciences
Study officials:
affiliation: University of Iceland
name: Sveinn H. Hardarson, PhD
role: PRINCIPAL_INVESTIGATOR
References: