UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040294
Receipt number R000045972
Scientific Title Evaluation of retinal vascular function in patients with vitreoretinal disorders
Date of disclosure of the study information 2020/05/10
Last modified on 2020/05/02 13:47:30

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Basic information

Public title

Evaluation of retinal vascular function in patients with vitreoretinal disorders

Acronym

Evaluation of retinal vascular function

Scientific Title

Evaluation of retinal vascular function in patients with vitreoretinal disorders

Scientific Title:Acronym

Evaluation of retinal vascular function

Region

Japan


Condition

Condition

Diabetic retinopathy, Retinal vein occulusion

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate neurovascular function in the retina by flicker-induced increase in ocular blood flow and exmaine whether this examination may be useful for the prediction and prevention of these diseases.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The response of ocular blood flow in response to the flicker-stimulation.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Flicker-stimulation (12 Hz, 3 minutes)

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with retinal vascular disorders

Key exclusion criteria

Poor visual acuity, past ocular surgery, poor glycemic control

Target sample size

40


Research contact person

Name of lead principal investigator

1st name TAIJI
Middle name
Last name NAGAOKA

Organization

Nihon University School of Medicine

Division name

Division of Ophthalmology, Department of Visual Sciences

Zip code

173-8610

Address

30-1 Oyaguchi-Kamicho, Itabashi-ku, Tokyo

TEL

03-3972-8111

Email

taijinagaoka@gmail.com


Public contact

Name of contact person

1st name TAIJI
Middle name
Last name NAGAOKA

Organization

Nihon University School of Medicine

Division name

Division of Ophthalmology, Department of Visual Sciences

Zip code

173-8610

Address

30-1 Oyaguchi-Kamicho, Itabashi-ku, Tokyo

TEL

03-3972-8111

Homepage URL


Email

taijinagaoka@gmail.com


Sponsor or person

Institute

Nihon University

Institute

Department

Personal name



Funding Source

Organization

Nihon 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

Nihon University IRB

Address

30-1 Oyaguchi-Kamicho, Itabashi-ku, Tokyo

Tel

03-3972-8111

Email

komoda.nozomi@nihon-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

2020 Year 05 Month 10 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

Preinitiation

Date of protocol fixation

2020 Year 04 Month 20 Day

Date of IRB


Anticipated trial start date

2020 Year 06 Month 01 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



Management information

Registered date

2020 Year 05 Month 02 Day

Last modified on

2020 Year 05 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045972


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name