Chorioretinal Disorders in Diseases Classified ElsewhereNCT02318641
Measurement of the Oxygen Saturation in the Retinal Vessels With Oxymap
An observational study of Chorioretinal Disorders in Diseases Classified Elsewhere, run by Kagawa University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chorioretinal Disorders in Diseases Classified Elsewhere
- What is being tested?
- oximetry
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2014to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy eyes and eyes with various chorioretinal disease.
Who may be able to join
- 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.
Who cannot join
- Eye with medial opacity.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Kagawa University Faculty of Medicine
Hiragi, Kagawa-ken, 761-0793
+81878912211, chosa@med.kagawa-u.ac.jp
About this study
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.
Read the 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.
- Being tested
- oximetry
- Keywords
- oxygen consumption, retinal oximetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oximetryDevice
Retinal oximetry will be performed with Oxymap.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of retinal oxygen saturation from baseline at 6 months
Measured: Six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chorioretinal Disorders in Diseases Classified ElsewhereStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kagawa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akitaka Tsujikawa, Kagawa University
- Investigators
- AKITAKA TSUJIKAWA, MD, Principal investigator, Kagawa Univerisity Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318641
- Sponsor's protocol ID
- H26-046
- Status last verified
- Mar 2018
- First submitted
- 12 Dec 2014
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of the Oxygen Saturation in the Retinal Vessels With Oxymap
- ClinicalTrials.gov ID
- NCT02318641
- Acronym / sponsor ID
- H26-046
- Keywords
- oxygen consumption, retinal oximetry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Kagawa UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 17 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy eyes and eyes with various chorioretinal disease.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Eye with medial opacity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oximetryRetinal oximetry will be performed with Oxymap. | Device | – |
Primary outcome
Change of retinal oxygen saturation from baseline at 6 months
Time frame: Six months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AKITAKA TSUJIKAWA, MD principal investigator
Kagawa Univerisity Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chorioretinal Disorders in Diseases Classified Elsewhere, run by Kagawa University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chika Akuta (+81878912211, kaomie@med.kagawa-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of retinal oxygen saturation from baseline at 6 months (time frame: Six months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.