UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of ocular blood flow changes in the retinopathy of prematurity with Laser speckle flowgraphy (LSFG)
Title of the study (Brief title)	Ocular blood flow changes in the retinopathy of prematurity
Region	Japan

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

Objectives
Narrative objectives1	To examine relationship between stage of retinopathy of prematurity and ocular blood flow
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Ocular blood flow value (MBR) of the optic nerve head with LSFG
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	30 weeks-old <=
Age-upper limit	52 weeks-old >
Gender	Male and Female
Key inclusion criteria	Pretern infants, ,less than 34weeks postconceptional age, who are hospitalized in the neonatal intensive care unit at Toho University Omori Medical Center are eligible for enrollment. Written informed consent was obtained from parent of each neonate.
Key exclusion criteria	1.neonate with chromosomal anomaly 2.neonate with severe systemic diseases 3.neonate with ophthalmogic abnormality 4.neonate who is judged to be inappropriate as sublect.
Target sample size	100

Research contact person
Name of lead principal investigator	Tadashi Matsumoto
Organization	School of Medicine Toho University
Division name	Department of Ophthalmology
Address	6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541
TEL	81-3-3762-4151
Email	matsu-t@med.toho-u.ac.jp

Public contact
Name of contact person	Tadashi Matsumoto
Organization	School of Medicine Toho University
Division name	Department of Ophthalmology
Address	6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541
TEL	81-3-3762-4151
Homepage URL
Email	matsu-t@med.toho-u.ac.jp

Sponsor
Institute	School of Medicine Toho University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2016 Year 07 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 09 Day
Anticipated trial start date	2016 Year 07 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Measurement of ocular blood flow using LSFG at the same time as a medical examination of retinopathy of prematurity

Management information
Registered date	2016 Year 07 Month 06 Day
Last modified on	2018 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026556