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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029378
Receipt No. R000033415
Scientific Title Changes of iris morphological feature after anti-VEGF intravitreal injection
Date of disclosure of the study information 2017/10/02
Last modified on 2019/04/08

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Basic information
Public title Changes of iris morphological feature after anti-VEGF intravitreal injection
Acronym Changes of iris morphological feature after anti-VEGF intravitreal injection
Scientific Title Changes of iris morphological feature after anti-VEGF intravitreal injection
Scientific Title:Acronym Changes of iris morphological feature after anti-VEGF intravitreal injection
Region
Japan

Condition
Condition Branch retinal vein occlusion,Central retinal vein occlusion
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the changes of iris morphological features before and after anti-VEGF intravitreal investigation.
Basic objectives2 Others
Basic objectives -Others morphological features
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Iris thickness at 1mm and 2mm from pupil edge,iris length were analyzed at baseline, 1M, 3M, 6M, 12M after anti-VEGF intravitreal injection.
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
20 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria 1)Patients with Branch retinal vein occlusion and Central retinal vein occlusion
2)history of no anti-VEGF intravireal injection
3)clear cross-sectional images were already obtained using the anterior segment mode and angle mode on swept-source(SS)-AsOCT(SS-1000 CASIATM,TOMEY,Nagoya,Japan).
Key exclusion criteria Except for above criteria
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Tomoaki
Middle name
Last name Sonobe
Organization saneikai tsukazaki Hospital
Division name Ophthalmology
Zip code 671-1227
Address Himeji City Aboshi Waku 68-1
TEL 0792728555
Email t.sonobe@tsukazaki-eye.net

Public contact
Name of contact person
1st name Tomoaki
Middle name
Last name Sonobe
Organization saneikai tsukazaki Hospital
Division name Ophthalmology
Zip code 671-1227
Address Himeji City Aboshi Waku 68-1
TEL 0792728555
Homepage URL
Email t.sonobe@tsukazaki-eye.net

Sponsor
Institute saneikai tsukazaki Hospital
Institute
Department

Funding Source
Organization saneikai tsukazaki Hospital
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 saneikai tsukazaki Hospital
Address Himeji City Aboshi Waku 68-1
Tel 0792728555
Email t.sonobe@tsukazaki-eye.net

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 02 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 Open public recruiting
Date of protocol fixation
2017 Year 09 Month 23 Day
Date of IRB
2017 Year 09 Month 23 Day
Anticipated trial start date
2017 Year 09 Month 23 Day
Last follow-up date
2019 Year 10 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information nothing

Management information
Registered date
2017 Year 10 Month 02 Day
Last modified on
2019 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033415

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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