UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between fundus structure and hemodynamics in children with refractive error
Acronym	Hemodynamics in Pediatric Eyes with Refractive Error
Scientific Title	Relationship between fundus structure and hemodynamics in children with refractive error
Scientific Title:Acronym	Hemodynamics in Pediatric Eyes with Refractive Error
Region	Japan

Condition
Condition	patients with refract error
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the hemodynamic changes due to differences in fundus structure caused by refractive error
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	blood flow, refraction power, axial length
Key secondary outcomes	Gender, age, cause of low vision, presence of systemic disease, visual acuity,reproducibility

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	5 years-old <=
Age-upper limit	15 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with refractive error eyes between the ages of 5 and 15 years who were followed up at the Department of Ophthalmology, Toho University Medical Center Omori Hospital from April 2015 to July 2022 are included in this study.
Key exclusion criteria	Patients who cannot tolerate imaging studies due to trauma, or the presence of ocular disease requiring structural abnormalities such as retinal detachment, cataracts, corneal scarring, uveitis, or developmental disorders are excluded. Patients with inadequate examination data or unclear imaging data that interfere with data analysis are also excluded.
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Matsumoto Middle name Last name Tadashi
Organization	Toho University Omori Medical Center
Division name	Ophthalmology
Zip code	143-8541
Address	6-11-1, Omorinishi, Ota-ku, Tokyo
TEL	03-3762-4151
Email	matsu-t@med.toho-u.ac.jp

Public contact
Name of contact person	1st name Itokawa Middle name Last name Takashi
Organization	Toho University Omori Medical Center
Division name	Ophthalmology
Zip code	143-8541
Address	6-11-1, Omorinishi, Ota-ku, Tokyo
TEL	03-3762-4151
Homepage URL
Email	takashi.itokawa@med.toho-u.ac.jp

Sponsor
Institute	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)

IRB Contact (For public release)
Organization	Ethics Committee of Toho University Omori Medical Center
Address	6-11-1, Omorinishi, Ota-ku, Tokyo
Tel	03-5763-6534
Email	omori.rinri@ext.toho-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	2022 Year 10 Month 24 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	35
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	2015 Year 04 Month 01 Day
Date of IRB	2022 Year 10 Month 04 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2022 Year 07 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective study

Management information
Registered date	2022 Year 10 Month 24 Day
Last modified on	2022 Year 10 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056127