UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023041 |
|---|---|
| Receipt number | R000026556 |
| Scientific Title | Study of ocular blood flow changes in the retinopathy of prematurity with Laser speckle flowgraphy (LSFG) |
| Date of disclosure of the study information | 2016/07/06 |
| Last modified on | 2018/07/09 14:29:17 |
* 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 ocular blood flow changes in the retinopathy of prematurity with Laser speckle flowgraphy (LSFG)
Acronym
Ocular blood flow changes in the retinopathy of prematurity
Scientific Title
Study of ocular blood flow changes in the retinopathy of prematurity with Laser speckle flowgraphy (LSFG)
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Tadashi Matsumoto |
Organization
School of Medicine Toho University
Division name
Department of Ophthalmology
Zip code
Address
6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541
TEL
81-3-3762-4151
matsu-t@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadashi Matsumoto |
Organization
School of Medicine Toho University
Division name
Department of Ophthalmology
Zip code
Address
6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541
TEL
81-3-3762-4151
Homepage URL
matsu-t@med.toho-u.ac.jp
Sponsor or person
Institute
School of Medicine Toho University
Institute
Department
Personal name
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
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 09 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026556
