UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023767
Receipt number R000027380
Scientific Title Comparison of efficacy between OCT angiography and fluorescein angiography in the eyes with chorioretinal diseases
Date of disclosure of the study information 2016/08/26
Last modified on 2017/02/28 13:27:37

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Basic information

Public title

Comparison of efficacy between OCT angiography and fluorescein angiography in the eyes with
chorioretinal diseases

Acronym

Comparison of efficacy between OCT angiography and fluorescein angiography

Scientific Title

Comparison of efficacy between OCT angiography and fluorescein angiography in the eyes with
chorioretinal diseases

Scientific Title:Acronym

Comparison of efficacy between OCT angiography and fluorescein angiography

Region

Japan


Condition

Condition

diabetic retinopathy (macular edema), branch retinal vein occlusion, wet type of age-related macular
degeneration

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the value of OCT angiography, we compare the result between OCT angigraphy and fluorescein angiography in the same eye

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Detection rate of the lesion in each eyes

Key secondary outcomes

Duration (minutes) for each angiography test


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

the patients with diabetic retinopathy (macular edema), BRVO or wAMD, who are scheduled for fluorescein angiography to diagnose or follow-up, and the patients who have not media opacity or poor fixation.

Key exclusion criteria

The patients who have allergy to dye, or renal dysfunction.
The patients who have possibility of pregnant or pregnant patients

Target sample size

90


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuichiro Ogura

Organization

Nagoya City University Hospital

Division name

Ophthalmology

Zip code


Address

1 Kawasumi Mizuho-cho Mizuho-ku Nagoya

TEL

052(853)8251

Email

ogura@med.nagoya-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Miho Nozaki

Organization

Nagoya City University Hospital

Division name

Ophthalmology

Zip code


Address

1 Kawasumi Mizuho-cho Mizuho-ku Nagoya

TEL

052(853)8251

Homepage URL


Email

nozakim@med.nagoya-cu.ac.jp


Sponsor or person

Institute

Nagoya City University Hospital

Institute

Department

Personal name



Funding Source

Organization

Japanese Ophthalmic Instruments Association

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Kagoshima University Hospital
Tokyo Women's Medical University Hospital
Kagawa University Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

東京女子医科大学病院(東京都)
名古屋市立大学病院(愛知県)
鹿児島大学病院(鹿児島県)
園田病院(鹿児島県)
香川大学病院(香川県)


Other administrative information

Date of disclosure of the study information

2016 Year 08 Month 26 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2016 Year 08 Month 24 Day

Date of IRB


Anticipated trial start date

2016 Year 08 Month 26 Day

Last follow-up date


Date of closure to data entry

2016 Year 12 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

recruiting


Management information

Registered date

2016 Year 08 Month 25 Day

Last modified on

2017 Year 02 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027380


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name