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Clinical Trials/NCT02523339
NCT02523339CompletedNot Applicable

Multicenter Study of Retinal Oxygenation in Central Retinal Vein Occlusion

University of Iceland8 sites in 7 countries117 target enrollmentStarted: October 2014Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
117
Locations
8
Primary Endpoint
Visual acuity
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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.

Outcomes

Primary Outcomes

Visual acuity

Time Frame: 12 months

Retinal vessel oxygen saturation

Time Frame: 12 months

Central retinal thickness

Time Frame: 12 months

Presence or absence of ocular neovascularisation

Time Frame: 12 months

As determined by gonioscopic examination

Secondary Outcomes

  • Presence or absence of ocular neovascularisation(6 months)
  • Central retinal thickness(6 months)
  • Visual acuity(6 months)
  • Retinal vessel oxygen saturation(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sveinn Hakon Hardarson

Post-doctoral researcher

University of Iceland

Study Sites (8)

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Study of Retinal Oxygenation in Central... | Clinical Trial