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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029512
Receipt No. R000033723
Scientific Title The change of intraocular pressure after intravitreous injection for retinopathy of prematurity
Date of disclosure of the study information 2017/10/15
Last modified on 2019/04/05

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Basic information
Public title The change of intraocular pressure after intravitreous injection for retinopathy of prematurity
Acronym Intraocular pressure after intravitreous injection for retinopathy of prematurity
Scientific Title The change of intraocular pressure after intravitreous injection for retinopathy of prematurity
Scientific Title:Acronym Intraocular pressure after intravitreous injection for 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 evaluate the change of intraocular pressure after intravitreous injection for retinopathy of prematurity
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Intraocular pressures at 1 minutes after intravitreous injection
Key secondary outcomes Intra ocular pressures of 3, 10, 30, 60 minutes and 1day after intravitreous injection.
Preoperative risk factors for intraocular pressure increasing.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Intraocular pressure is measured at pre injection, 1, 3, 10, 30, 60 minutes and 1day after injection.
Axial length, depth of anterior chamber, thickness of lens, thickness of cornea are measured at pre injection.
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 1) Patients with retinopathy of prematurity requiring intravitreal injection.
2) Those who can obtain agreement about this research participation by parents.
Key exclusion criteria None
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoaki Higashiyama
Organization Shiga University of Medical Scinece
Division name Department of Ophthalmology
Zip code
Address Seta Tsukinowacho, Otsu, Shiga, JAPAN
TEL 0775482276
Email higashi@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shumpei Obata
Organization Shiga University of Medical Scinece
Division name Department of Ophthalmology
Zip code
Address Seta Tsukinowacho, Otsu, Shiga, JAPAN
TEL 0775482276
Homepage URL
Email obata326@belle.shiga-med.ac.jp

Sponsor
Institute Department of Ophthalmology, Shiga University of Medical Science
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 10 Month 15 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
2017 Year 10 Month 06 Day
Date of IRB
2017 Year 10 Month 15 Day
Anticipated trial start date
2017 Year 10 Month 15 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 20 Day
Date trial data considered complete
2019 Year 03 Month 20 Day
Date analysis concluded
2019 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 10 Month 11 Day
Last modified on
2019 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033723

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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