UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of the anterior eye by polarization sensitive optical coherence tomography
Acronym	Polarization sensitive OCT of anterior eye
Scientific Title	Investigation of the anterior eye by polarization sensitive optical coherence tomography
Scientific Title:Acronym	Polarization sensitive OCT of anterior eye
Region	Japan

Condition
Condition	Glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigate the image contrasts of the tissues in the anterior eye by polarization sensitive optical coherence tomography
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	The visibility of individual tissues in PSOCT images are graded by multiple graders with discrete score levels.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The subjects who were explained about this study and then agreed with this study. The subject may contain normal healthy subjects, subjects who are suffered by anterior and or posterior eye disorders.
Key exclusion criteria	The subjects without informed consent will be rejected from this study.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshiaki Yasuno
Organization	University of Tsukuba
Division name	Institute of Applied Physics
Zip code
Address	Tennodai 1-1-1, Tsukuba, Ibaraki, Japan
TEL	029-853-5217
Email

Public contact
Name of contact person	1st name Middle name Last name Yoshiaki Yasuno
Organization	University of Tsukuba
Division name	Institute of Applied Physics
Zip code
Address	Tennodai 1-1-1, Tsukuba, Ibaraki, Japan
TEL	029-853-5217
Homepage URL
Email	yasuno@optlab2.bk.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Tokyo medical university
Name of secondary funder(s)	Tomey Corporation

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	2008 Year 12 Month 05 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results	The visibility of trabecular meshwork is significantly improved by PSOCT in comparison to that of standard OCT. (Optics and Photonics Japan 2008)
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	2008 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2008 Year 04 Month 01 Day
Last follow-up date	2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	A trabecular meshwork is visualized as a bending pattern in the phase retardation optical coherence tomography images.

Management information
Registered date	2008 Year 12 Month 05 Day
Last modified on	2009 Year 12 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001879

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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