Clincosm LogoSign in Get a demo

Study of Retinal Oxygenation in Central Retinal Vein Occlusion

Sponsor
University of Iceland (Other)
Overall Status
Completed
CT.gov ID
NCT02523339
Collaborator
University Hospital, Basel, Switzerland (Other), Aston University (Other), University of Jena (Other), Medical University of Vienna (Other), University of Aarhus (Other), Clinical Research Center Memorial A. de Rothschild (Other), Palacky University (Other), University of Toyama (Other)
117
Enrollment
8
Locations
73.1
Duration (Months)
14.6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    117 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Multicenter Study of Retinal Oxygenation in Central Retinal Vein Occlusion
    Study Start Date :
    Oct 1, 2014
    Actual Primary Completion Date :
    Jun 1, 2018
    Actual Study Completion Date :
    Nov 3, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Retinal vessel oxygen saturation [12 months]

    2. Visual acuity [12 months]

    3. Central retinal thickness [12 months]

    4. Presence or absence of ocular neovascularisation [12 months]

      As determined by gonioscopic examination

    Secondary Outcome Measures

    1. Retinal vessel oxygen saturation [Baseline]

    2. Visual acuity [Baseline]

    3. Central retinal thickness [Baseline]

    4. Presence or absence of ocular neovascularisation [Baseline]

      As determined by gonioscopic examination

    5. Retinal vessel oxygen saturation [3 months]

    6. Visual acuity [3 months]

    7. Central retinal thickness [3 months]

    8. Presence or absence of ocular neovascularisation [3 months]

      As determined by gonioscopic examination

    9. Retinal vessel oxygen saturation [6 months]

    10. Visual acuity [6 months]

    11. Central retinal thickness [6 months]

    12. Presence or absence of ocular neovascularisation [6 months]

      As determined by gonioscopic examination

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Sveinn H. Hardarson, PhD, University of Iceland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sveinn Hakon Hardarson, Post-doctoral researcher, University of Iceland
    ClinicalTrials.gov Identifier:
    NCT02523339
    Other Study ID Numbers:
    • UI-CRVO-2015
    First Posted:
    Aug 14, 2015
    Last Update Posted:
    Feb 12, 2021
    Last Verified:
    Feb 1, 2021
    Additional relevant MeSH terms:
    Retinal Vein Occlusion

    Study Results

    No Results Posted as of Feb 12, 2021