UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035273
Receipt number 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 22:03:29

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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 or person

Institute

Department of Ophthalmology, Tohoku University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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