UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037540
Receipt number R000042729
Scientific Title Study of the relationship between choroidal thickness and choroidal circulation in retinal diseases
Date of disclosure of the study information 2019/08/01
Last modified on 2021/03/20 11:09:48

* 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

Study of the relationship between choroidal thickness and choroidal circulation in retinal diseases

Acronym

Study of the relationship between choroidal thickness and choroidal circulation in retinal diseases

Scientific Title

Study of the relationship between choroidal thickness and choroidal circulation in retinal diseases

Scientific Title:Acronym

Study of the relationship between choroidal thickness and choroidal circulation in retinal diseases

Region

Japan


Condition

Condition

retinal disease, choroidal disease

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To measure of choroidal thickness and choroidal circulation in the eye with retinal and choroidal disease.

Basic objectives2

Others

Basic objectives -Others

observational research

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

choroidal thickness, choroidal circulation

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

Cases with retinal disease or choroidal disease (diabetic retinopathy, retinal vascular occlusion, age-related macular degeneration, Harada disease, central serous chorioretinopathy, etc.).
Cases in which consent was obtained for this study

Key exclusion criteria

Cases in which no consent was obtained for this study.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Hidetoshi
Middle name
Last name Yamashita

Organization

Yamagata University Faculty of Medicine

Division name

Department of Ophthalmology

Zip code

990-9585

Address

2-2-2 Iida-nishi, Yamagata city, Yamagata, Japan

TEL

023-628-5374

Email

hyama-tky@umin.ac.jp


Public contact

Name of contact person

1st name Sakiko
Middle name
Last name Goto

Organization

Yamagata University Faculty of Medicine

Division name

Department of Ophthalmology

Zip code

990-9585

Address

2-2-2 Iida-nishi, Yamagata city, Yamagata, Japan

TEL

023-628-5374

Homepage URL


Email

nakano-ygt@umin.ac.jp


Sponsor or person

Institute

Yamagata University

Institute

Department

Personal name



Funding Source

Organization

Yamagata University

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

Yamagata University Faculty of Medicine

Address

2-2-2 Iida-nishi, Yamagata city, Yamagata, Japan

Tel

023-628-5047

Email

ikekenkyu@jm.kj.yamagata-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

2019 Year 08 Month 01 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

21

Results

The subjects were 39 eyes in 21 cases with diabetes . The cases with cancer were the mean foveal retinal thickness was 233.8um, and the mean foveal choroidal thickness was 199.4 um. The cases without cancer were the mean foveal retinal thickness was 231.2 um, and the mean foveal choroidal thickness was 191.8 um. No association was found between the state of diabetic retinopathy and the retinal and choroidal thickness.

Results date posted

2021 Year 03 Month 20 Day

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

none

IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 02 Month 14 Day

Date of IRB

2019 Year 03 Month 11 Day

Anticipated trial start date

2019 Year 04 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

We obtain the data within normal medial examination.


Management information

Registered date

2019 Year 07 Month 30 Day

Last modified on

2021 Year 03 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042729


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name