Measurement of the Oxygen Saturation in the Retinal Vessels With Oxymap

Chorioretinal Disorders in Diseases Classified Elsewhere Clinical Trial

Official title:

Measurement of the Oxygen Saturation in the Retinal Vessels With Oxymap

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02318641
• Other study ID #: H26-046
• Status: Recruiting
• Phase: N/A
• First received: December 12, 2014
• Last updated: March 6, 2018
• Start date: December 2014
• Est. completion date: December 2018

Study information

• Verified date: March 2018
• Source: Kagawa University
• Contact: Chika Akuta
• Phone: +81878912211
• Email: kaomie[@]med.kagawa-u.ac.jp
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Chorioretinal Disorders in Diseases Classified Elsewhere

Intervention

Device:
• oximetry
Retinal oximetry will be performed with Oxymap.

Locations

Country	Name	City	State
Japan	Kagawa University Faculty of Medicine	Miki	Kagawa

Sponsors (1)

Lead Sponsor	Collaborator
Kagawa University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of retinal oxygen saturation from baseline at 6 months		Six months.