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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033375
Receipt No. R000038050
Scientific Title Anterior Segment Microvasculature Using Optical Coherence Tomography Angiography after Glaucoma Eye-drops Study
Date of disclosure of the study information 2018/08/01
Last modified on 2018/07/12

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Basic information
Public title Anterior Segment Microvasculature Using Optical Coherence Tomography Angiography after Glaucoma Eye-drops Study
Acronym AS-OCTA-ED Study
Scientific Title Anterior Segment Microvasculature Using Optical Coherence Tomography Angiography after Glaucoma Eye-drops Study
Scientific Title:Acronym AS-OCTA-ED Study
Region
Japan

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

Objectives
Narrative objectives1 To investigate the influence of glaucoma eye-drops on the optical coherence tomography angiography images
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Vessel density, Vessel length density, Vessel diameter, Fractal dimension
Key secondary outcomes Intraclass correlation coefficients

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
80 years-old >=
Gender Male and Female
Key inclusion criteria Male or female older than 20 years-old and younger than 80 years-old
Healthy subjects or patients with glaucoma/ocular hypertension
Key exclusion criteria Subjects who a doctor in attendance declares ineligible for any reason
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akitaka Tsujikawa
Organization Kyoto University Graduate School of Medicine
Division name Department of Ophthalmology and Visual Sciences
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-3248
Email eye@med.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tadamichi Akagi
Organization Kyoto University Graduate School of Medicine
Division name Department of Ophthalmology and Visual Sciences
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL 075-751-3727
Homepage URL
Email eye@med.kyoto-u.ac.jp

Sponsor
Institute Department of Ophthalmology & Visual Sciences, Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization Management Expenses Grants
Organization
Division
Category of Funding Organization Other
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
2018 Year 08 Month 01 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 Preinitiation
Date of protocol fixation
2018 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
2020 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information OCTA examinations are performed before and after eye-drop

Management information
Registered date
2018 Year 07 Month 12 Day
Last modified on
2018 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038050

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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