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Changes in the Diameter of Retinal Vessels After Remote Ischemic Conditioning

Primary Purpose

Retinal Artery Occlusion, Retinal Vein Occlusion

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Remote ischemic conditioning
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Retinal Artery Occlusion

Eligibility Criteria

20 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Normal persons

Exclusion Criteria:

  • Present or previous eye disease
  • Use of medications except anti-conceptive
  • Epilepsy
  • Pregnancy or lactation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Remote ischemic conditioning

    Arm Description

    Outcomes

    Primary Outcome Measures

    Diameter change of retinal vessel

    Secondary Outcome Measures

    Full Information

    First Posted
    September 8, 2016
    Last Updated
    April 4, 2019
    Sponsor
    University of Aarhus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02898480
    Brief Title
    Changes in the Diameter of Retinal Vessels After Remote Ischemic Conditioning
    Official Title
    Changes in the Diameter of Retinal Vessels After Remote Ischemic Conditioning
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2016 (undefined)
    Primary Completion Date
    November 14, 2016 (Actual)
    Study Completion Date
    May 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Aarhus

    4. Oversight

    5. Study Description

    Brief Summary
    Remote ischemic conditioning (RIC) is a therapeutic strategy for protecting organs or tissue against the detrimental effects of acute ischemia-reperfusion injury. It remains unknown whether this can be used in retinal vascular occlusive diseases. The purpose of the present study is to examine whether the autoregulation of retinal vessel diameters in normal persons change after remote ischemic conditioning.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Retinal Artery Occlusion, Retinal Vein Occlusion

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Remote ischemic conditioning
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Remote ischemic conditioning
    Intervention Description
    Briefly reversible restricting of blood flow to upper limb in four cycles of 5 minutes of inflation at 200mm Hg followed by 5 minutes of deflation.
    Primary Outcome Measure Information:
    Title
    Diameter change of retinal vessel
    Time Frame
    immediate

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Normal persons Exclusion Criteria: Present or previous eye disease Use of medications except anti-conceptive Epilepsy Pregnancy or lactation

    12. IPD Sharing Statement

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    Changes in the Diameter of Retinal Vessels After Remote Ischemic Conditioning

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