UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029512 |
|---|---|
| Receipt number | 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 15:57:22 |
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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
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
obata326@belle.shiga-med.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Shiga University of Medical Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033723
