UMIN-CTR Clinical Trial

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
Last 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
1st 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