UMIN-CTR Clinical Trial

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
Institute	Yamagata University
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042729