NCT02318641

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

4 years

First QC Date

December 12, 2014

Last Update Submit

March 6, 2018

Conditions

Keywords

oxygen consumptionretinal oximetry

Outcome Measures

Primary Outcomes (1)

  • Change of retinal oxygen saturation from baseline at 6 months

    Six months.

Interventions

oximetryDEVICE

Retinal oximetry will be performed with Oxymap.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy eyes and eyes with various chorioretinal disease.

You may qualify if:

  • 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.

You may not qualify if:

  • Eye with medial opacity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kagawa University Faculty of Medicine

Hiragi, Kagawa-ken, 761-0793, Japan

RECRUITING

MeSH Terms

Interventions

Oximetry

Intervention Hierarchy (Ancestors)

Blood Gas AnalysisBlood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHeart Function TestsDiagnostic Techniques, CardiovascularRespiratory Function TestsDiagnostic Techniques, Respiratory SystemInvestigative Techniques

Study Officials

  • AKITAKA TSUJIKAWA, MD

    Kagawa Univerisity Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chairman

Study Record Dates

First Submitted

December 12, 2014

First Posted

December 17, 2014

Study Start

December 1, 2014

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 7, 2018

Record last verified: 2018-03

Locations