UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022653
Receipt number 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 12:39:54

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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 or person

Institute

Tokyo Women's Medical University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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