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
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
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
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
