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Completed

NCT Number: NCT02523339

Study of Retinal Oxygenation in Central Retinal Vein Occlusion

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.

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Key information

Conditions

Retinal Vein Occlusion Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Retinal Diseases Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Retinal vessel oxygen saturation

    Time frame: 12 months

  2. Visual acuity

    Time frame: 12 months

  3. Central retinal thickness

    Time frame: 12 months

  4. Presence or absence of ocular neovascularisation

    Time frame: 12 months

    As determined by gonioscopic examination

Secondary outcomes

  1. Retinal vessel oxygen saturation

    Time frame: Baseline

  2. Visual acuity

    Time frame: Baseline

  3. Central retinal thickness

    Time frame: Baseline

  4. Presence or absence of ocular neovascularisation

    Time frame: Baseline

    As determined by gonioscopic examination

  5. Retinal vessel oxygen saturation

    Time frame: 3 months

  6. Visual acuity

    Time frame: 3 months

  7. Central retinal thickness

    Time frame: 3 months

  8. Presence or absence of ocular neovascularisation

    Time frame: 3 months

    As determined by gonioscopic examination

  9. Retinal vessel oxygen saturation

    Time frame: 6 months

  10. Visual acuity

    Time frame: 6 months

  11. Central retinal thickness

    Time frame: 6 months

  12. Presence or absence of ocular neovascularisation

    Time frame: 6 months

    As determined by gonioscopic examination

Sponsors and collaborators

Lead sponsor

University of Iceland

Other

Collaborators

  • 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

Registry information

Official study title

Multicenter Study of Retinal Oxygenation in Central Retinal Vein Occlusion

Important dates

Study start
2014
Primary completion
2018
Study completion
2020
First posted
Aug 14, 2015
Registry last updated
Feb 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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