UMIN-CTR Clinical Trial

Basic information
Public title	A multicenter study of retinopathy of prematurity in Yamagata Prefecture, Japan
Acronym	A multicenter study of retinopathy of prematurity in Yamagata Prefecture, Japan
Scientific Title	A multicenter study of retinopathy of prematurity in Yamagata Prefecture, Japan
Scientific Title:Acronym	A multicenter study of retinopathy of prematurity in Yamagata Prefecture, Japan
Region	Japan

Condition
Condition	Retinopathy of prematurity
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the epidemiology of retinopathy of prematurity by examining the preference rate and treatment rate.
Basic objectives2	Others
Basic objectives -Others	To identify factors correlated with the occurrence and progression of retinopathy of prematurity.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Factors correlated with the occurrence and progression of retinopathy of prematurity
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	Premature infants whose parents agreed with participating in this study. Premature infants examined by ophthalmologist on the purpose of screening for retinopathy of prematurity.
Key exclusion criteria	Premature infants whose parents disagreed with participating this study.
Target sample size	100

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 and Visual Sciences
Zip code	990-9585
Address	2-2-2 Iidanishi, Yamagata-shi, Yamagata, 990-2332, Japan
TEL	023-628-5374
Email	hyama-tky@umin.ac.jp

Public contact
Name of contact person	1st name Yusuke Middle name Last name Takeda
Organization	Yamagata University Faculty of Medicine
Division name	Department of Ophthalmology and Visual Sciences
Zip code	990-9585
Address	2-2-2 Iidanishi, Yamagata-shi, Yamagata, 990-2332, Japan
TEL	023-628-5374
Homepage URL
Email	y-takeda@med.id.yamagata-u.ac.jp

Sponsor
Institute	Department of Ophthalmology and Visual Sciences, Yamagata University Faculty of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yamaga University Facultiy od Medicine Institutional Review Board
Address	2-2-2 Iidanishi, Yamagata
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	山形大学医学部付属病院 山形県立中央病院 山形済生病院 鶴岡市立荘内病院

Other administrative information
Date of disclosure of the study information	2016 Year 11 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
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	Open public recruiting
Date of protocol fixation	2016 Year 09 Month 01 Day
Date of IRB	2016 Year 06 Month 22 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2019 Year 05 Month 31 Day
Date of closure to data entry	2019 Year 10 Month 31 Day
Date trial data considered complete	2019 Year 11 Month 30 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information	A multicenter, prospective, observation study. We collecte date over one year.

Management information
Registered date	2016 Year 10 Month 14 Day
Last modified on	2019 Year 12 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028018