Measurement of the Oxygen Saturation in the Retinal Vessels With Oxymap

March 6, 2018 updated by: Akitaka Tsujikawa, Kagawa University
Retinal oximetry can be measured with newly developed Oxymap (Oxymap ehf, Reykjavik, Iceland). Briefly, the device simultaneously acquires digital images at two wavelengths and automatically tracks retinal vessels on both images. Retinal vessel oxygen saturation is estimated by spectrophotometric analysis of light reflected from retinal vessels and from the immediately surrounding retina. Oxygen saturation measurements are made on major temporal arteries and veins. Briefly, the first and second degree vessels are used, with the addition of third degree vessels in images where peripapillary haemorrhage prevented analysis close to the optic disc. Vessel segments chosen for analysis are used consistently for consecutive measurements in the same retina.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Retinal oximetry can be measured with newly developed Oxymap (Oxymap ehf, Reykjavik, Iceland). Briefly, the device simultaneously acquires digital images at two wavelengths and automatically tracks retinal vessels on both images. Retinal vessel oxygen saturation is estimated by spectrophotometric analysis of light reflected from retinal vessels and from the immediately surrounding retina. Oxygen saturation measurements are made on major temporal arteries and veins. Briefly, the first and second degree vessels are used, with the addition of third degree vessels in images where peripapillary haemorrhage prevented analysis close to the optic disc. Vessel segments chosen for analysis are used consistently for consecutive measurements in the same retina.

Retinal oximetry in various chorioretinal diseases will be measured with Oxymap.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Kagawa
      • Miki, Kagawa, Japan, 761-0793

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy eyes and eyes with various chorioretinal disease.

Description

Inclusion Criteria:

  • Healthy eyes and eyes with various chorioretinal diseases, including diabetic retinopathy, retinal vein occlusion, epiretinal membrane, macular hole, inherited chorioretinal diseases, glaucoma, retinal detachment, etc.

Exclusion Criteria:

  • Eye with medial opacity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of retinal oxygen saturation from baseline at 6 months
Time Frame: Six months.
Six months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kagawa University

Investigators

  • Principal Investigator: AKITAKA TSUJIKAWA, MD, Kagawa Univerisity Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

December 12, 2014

First Submitted That Met QC Criteria

December 12, 2014

First Posted (Estimate)

December 17, 2014

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 6, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H26-046

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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