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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027773
Receipt No. R000031832
Scientific Title Iris morphological features of 360 degrees angle closure in patients with neovascular glaucoma
Date of disclosure of the study information 2017/06/15
Last modified on 2017/06/15

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Basic information
Public title Iris morphological features of 360 degrees angle closure in patients with neovascular glaucoma
Acronym Iris morphological features of 360 degrees angle closure in patients with neovascular glaucoma
Scientific Title Iris morphological features of 360 degrees angle closure in patients with neovascular glaucoma
Scientific Title:Acronym Iris morphological features of 360 degrees angle closure in patients with neovascular glaucoma
Region
Japan

Condition
Condition 360 degrees angle closure in patients with NVG
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the iris morphological features in 360 degrees angle closure NVG by swept-source anterior segment optical coherence tomography (SS-ASOCT).
Basic objectives2 Others
Basic objectives -Others morphological features
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Iris thickness at 1 mm and 2 mm from pupil edge, iris length, trabecular meshwork (TM) length, peripheral anterior synechia (PAS) length, the PAS ratio (PAS length /TM length) and pupil diameter were analyzed.
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) 360 degrees angle closure NVG confirmed by gonioscopic examination. When the trabecular pigment band was invisible, the area was diagnosed as closed. 2) who had intraocular lens implantation to exclude the effect of lens 3) history of no glaucoma surgery 4) 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 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunsuke Nakakura
Organization saneikai tsukazaki Hospital
Division name Ophthalmology
Zip code
Address Himeji City Aboshi Waku 68-1
TEL 079-272-8555
Email shunsukenakakura@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shunsuke Nakakura
Organization saneikai tsukazaki hospital
Division name Ophthalmology
Zip code
Address Himeji City Aboshi Waku 68-1
TEL 079-272-8555
Homepage URL
Email shunsukenakakura@yahoo.co.jp

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
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 06 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
2009 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In patients with 360 degrees angle closure NVG, iris thickness became thinning about 50% of healthy subjects. Additionally, the TM was completely closed by high PAS in most cases, this will explain high IOP.

Management information
Registered date
2017 Year 06 Month 15 Day
Last modified on
2017 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031832

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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