UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021644
Receipt number R000024960
Scientific Title Usefulness of OCT angiography for retinal and chroidal diseases.
Date of disclosure of the study information 2016/03/27
Last modified on 2019/03/31 22:18:18

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Basic information

Public title

Usefulness of OCT angiography for retinal and chroidal diseases.

Acronym

OCT angiography for retinal and chroidal diseases.

Scientific Title

Usefulness of OCT angiography for retinal and chroidal diseases.

Scientific Title:Acronym

OCT angiography for retinal and chroidal diseases.

Region

Japan


Condition

Condition

Various retinal and choroidal diseases.

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate detailed structure of retina/choroid vessels using Optical coherence tomography angiography (OCT Angio)for various diseases.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The difference between OCT Angio image and clinical 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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Those patients with retinal/choroidal diseases who can obtain ICs.

Key exclusion criteria

1)Difficulty for evaluation.
2)Patients can not obtain ICs(Especially patients under 20 yrs old)

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Masahiko
Middle name
Last name Sugimoto

Organization

Mie University, School of Medicine.

Division name

Department of Ophthalmology

Zip code

514-8507

Address

Edobashi

TEL

0592315027

Email

sugmochi@clin.medic.mie-u.ac.jp


Public contact

Name of contact person

1st name Masahiko
Middle name
Last name Sugimoto

Organization

Mie University, School of Medicine.

Division name

Department of Ophthalmology

Zip code

514-8507

Address

Edobashi

TEL

0592315027

Homepage URL


Email

hmatsu@clin.medic.mie-u.ac.jp


Sponsor or person

Institute

Department of Ophthalmology, Mie University, School of Medicine.

Institute

Department

Personal name



Funding Source

Organization

Department of Ophthalmology, Mie University, School of Medicine.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Mie University

Address

2-174, Edobashi, Tsu, Mie

Tel

0592315027

Email

sugmochi@clin.medic.mie-u.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 03 Month 27 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2016 Year 02 Month 15 Day

Date of IRB

2016 Year 02 Month 15 Day

Anticipated trial start date

2016 Year 02 Month 15 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We use RS-3000 Advance(NIDEK).

Patients are evaluated fundus under mydriasis.
We compare result of OCT-Angio and fundus evaluation.


Management information

Registered date

2016 Year 03 Month 27 Day

Last modified on

2019 Year 03 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024960


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name