UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022653
Receipt No. R000026002
Scientific Title Clinical evaluation of the noninvasive retinal and choroidal angiographic visualization using high resolution optical coherence tomography
Date of disclosure of the study information 2016/06/08
Last modified on 2020/06/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Clinical evaluation of the noninvasive retinal and choroidal angiographic visualization using high resolution optical coherence tomography
Acronym Clinical evaluation of high resolution OCT angiography
Scientific Title Clinical evaluation of the noninvasive retinal and choroidal angiographic visualization using high resolution optical coherence tomography
Scientific Title:Acronym Clinical evaluation of high resolution OCT angiography
Region
Japan

Condition
Condition Ocular fundus disease
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the performance of chorioretinal blood vessel visualization and its characteristics themselves that could not be identified by conventional OCT for the clinical application after acquiring the images of the healthy eyes and the eyes with fundus abnormalities using high resolution OCT with 3micron depth resolution using OCT angiography techniques.
Basic objectives2 Others
Basic objectives -Others To compare the chorioretinal blood vessel images using OCT angiography with the images using conventional fluorescein and indocyanine green angiography.
To evaluate the utility of 3 dimensional analysis from the obtained data.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To compare the chorioretinal blood vessel images of OCT angiography about the clarity and particularity between the target OCT device and other OCT devices by several examiners for clinical utility evaluation.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with the ocular fundus disease and haelthy volunteers who consent to participate in this study
Key exclusion criteria 1. Subjects who a doctor declares difficulty of image acquisition because of cataract in slit lamp examination
2. Subjects who a doctor declares ineligible for any other reasons
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Tomohiro
Middle name
Last name Iida
Organization Tokyo Women's Medical University School of Medicine
Division name Ophthalmology
Zip code 1628666
Address 8-1 Kawadacho, Shinjuku-ku, Tokyo, JAPAN
TEL 03-3353-8111
Email iida@oph.twmu.ac.jp

Public contact
Name of contact person
1st name Ichiro
Middle name
Last name Maruko
Organization Tokyo Women's Medical University School of Medicine
Division name Ophthalmology
Zip code 1628666
Address 8-1 Kawadacho, Shinjuku-ku, Tokyo, JAPAN
TEL 03-3353-8111
Homepage URL
Email imaruko@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University School of Medicine
Institute
Department

Funding Source
Organization Tokyo Women's Medical University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor CANON INC
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Women's Medical University School of Medicine
Address 8-1 Kawadacho, Shinjuku-ku, Tokyo, JAPAN
Tel 03-3353-8111
Email krinri.bm@twmu.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 06 Month 08 Day

Related information
URL releasing protocol https://link.springer.com/article/10.1007/s00417-019-04275-5
Publication of results Unpublished

Result
URL related to results and publications https://link.springer.com/article/10.1007/s00417-019-04275-5
Number of participants that the trial has enrolled 27
Results The average PSNR for the A-images was 14.0 which was significantly higher than the 12.2 for the S-images (P<0.01). However, the average VD was 33.6% for the S-images and 34.8% for the A-images (P>0.1). The average FD was 1.67 for the S-images and 1.54 for the A-images (P<0.01). The mean luminance difference obtained by subtracting the luminance of the A-image from the S-image after BPF processing was 10.41 db which was positive for all eyes.
Results date posted
2020 Year 06 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Twenty-seven eyes of 25 patients (18 men, 7 women; average age 71.0 years) with a CNV were examined by OCTA (OCT HS-100, Canon. Japan).
Participant flow Analyses were performed on a single image (S-image) and the average of five single images of the same area (A-images).
Adverse events None
Outcome measures the peak signal-to-noise ratio (PSNR), the vascular density (VD), fractal dimension (FD), and the noise component using band pass filter (BPF) processing of the S- and A-images of each case were compared.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 05 Month 31 Day
Date of IRB
2016 Year 05 Month 31 Day
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2017 Year 12 Month 31 Day
Date trial data considered complete
2017 Year 12 Month 31 Day
Date analysis concluded

Other
Other related information Prospective observational study
Patients with the ocular fundus disease and haelthy volunteers who consent to participate. (Patients who visit or hospitalize to Tokyo Women's Medical University. Healthy volunteers who work at Tokyo Women's Medical University as a doctor.)

Management information
Registered date
2016 Year 06 Month 08 Day
Last modified on
2020 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026002

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.