UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033375 |
|---|---|
| Receipt number | 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 | 2020/07/28 18:32:39 |
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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 | Akitaka |
| Middle name | |
| Last name | Tsujikawa |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Sciences
Zip code
6068507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3248
eye@med.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadamichi |
| Middle name | |
| Last name | Akagi |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Sciences
Zip code
6068507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-3727
Homepage URL
eye@med.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology & Visual Sciences, Kyoto University Graduate School of Medicine
Institute
Department
Personal name
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
Department of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
Tel
075-751-3248
eye@med.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
R1652
Org. issuing International ID_1
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都大学医学部附属病院（京都府）
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
21
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
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 25 | 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
| 2020 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038050
