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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035273
Receipt No. R000040176
Scientific Title Prospective observational study of blood flow alterations in response to provocation tests and progression in ophthalmic disorders including glaucoma
Date of disclosure of the study information 2018/12/16
Last modified on 2018/12/16

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Basic information
Public title Prospective observational study of blood flow alterations in response to provocation tests and progression in ophthalmic disorders including glaucoma
Acronym Blood flow alterations in response to provocation tests in ophthalmic disorders
Scientific Title Prospective observational study of blood flow alterations in response to provocation tests and progression in ophthalmic disorders including glaucoma
Scientific Title:Acronym Blood flow alterations in response to provocation tests in ophthalmic disorders
Region
Japan

Condition
Condition Glacuoma, cataract, dry eye, diabetic retinopathy, retinal vein occlusion, hypertensive retinopathy
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We prospectively investigate the relationship between blood flow alterations in response to provocation tests and visual field progression in glaucoma patients. In addition, we investigate the blood flow alterations in response to provocation tests in ophthalmic disorders, including diabetic retinopathy, retinal vein occlusion, hypertensive retinopathy, cataract and dry eye patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between ocular blood flow alterations in response to provocation tests and glaucoma progression.
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
70 years-old >
Gender Male and Female
Key inclusion criteria 1. Open angle
2. From preperimetric to moderate glaucoma stages
3. Reliable results of visual filed test
4, Obtain for informed consent
Key exclusion criteria 1. High myopia
2. Intraocular pressure above 22mmHg in both eyes
3. Allergy for topical medications
4. Pregnancy
5. Current smoker
6. History of uncomfortable for provocation tests
7. Impossible to assess ocular blood flow because of severe cataract
8. Presence of ocular fundus disorders other than diabetic retinopathy and retinal vein occlusion
9. Impossible to obtain informed consent
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Kunikata
Organization Tohoku University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
Address 1-1, Seiryo-cho, Aoba-ku, Sendai-shi
TEL 0227177294
Email kunikata@oph.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukihiro Shiga
Organization Tohoku University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
Address 1-1, Seiryo-cho, Aoba-ku, Sendai-shi
TEL 0227177294
Homepage URL
Email y.shiga@oph.med.tohoku.ac.jp

Sponsor
Institute Department of Ophthalmology, Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization Self funding and Center of Innovation Program
Organization
Division
Category of Funding Organization Japanese Governmental office
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 12 Month 16 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 12 Month 17 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study

Management information
Registered date
2018 Year 12 Month 16 Day
Last modified on
2018 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040176

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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