NCT02523339

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
7 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2020

Completed
Last Updated

February 12, 2021

Status Verified

February 1, 2021

Enrollment Period

3.7 years

First QC Date

August 7, 2015

Last Update Submit

February 11, 2021

Conditions

Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (12)

  • Retinal vessel oxygen saturation

    Baseline

  • Visual acuity

    Baseline

  • Central retinal thickness

    Baseline

  • Presence or absence of ocular neovascularisation

    Baseline

  • Retinal vessel oxygen saturation

    3 months

  • +7 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Location

Department of Ophthalmology, University Hospital and Faculty of Medicine and Dentistry, Palacky University Olomouc

Olomouc, 77900, Czechia

Location

Aarhus University. Department of Clinical Medicine - The Department of Ophthalmology

Aarhus, 8000, Denmark

Location

University Hospital Jena

Jena, 07743, Germany

Location

University of Iceland / Landspitali, Dept. of Ophthalmology

Reykjavik, 101, Iceland

Location

Eye Clinic of the University Hospital Basel

Basel, Canton of Basel-City, 4055, Switzerland

Location

Clinical Research Center Memorial A. de Rothschild

Geneva, 1208, Switzerland

Location

Aston University School of Life and Health Sciences

Birmingham, B4 7ET, United Kingdom

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Sveinn H. Hardarson, PhD

    University of Iceland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-doctoral researcher

Study Record Dates

First Submitted

August 7, 2015

First Posted

August 14, 2015

Study Start

October 1, 2014

Primary Completion

June 1, 2018

Study Completion

November 3, 2020

Last Updated

February 12, 2021

Record last verified: 2021-02

Locations

DE(1)CH(2)GB(1)AU(1)CZ(1)IC(1)DK(1)