UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective observational study of blood flow alterations in response to provocation tests and progression in ophthalmic disorders including glaucoma
Title of the study (Brief title)	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	Hiroshi Kunikata
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Ophthalmology
Address	1-1, Seiryo-cho, Aoba-ku, Sendai-shi
TEL	0227177294
Email	kunikata@oph.med.tohoku.ac.jp

Public contact
Name of contact person	Yukihiro Shiga
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Ophthalmology
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 12 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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