UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039667 |
|---|---|
| Receipt number | R000045006 |
| Scientific Title | Relationship between ocular blood flow and structure-function in glaucoma patients. |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2020/09/14 12:48:36 |
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Basic information
Public title
Relationship between ocular blood flow and structure-function in glaucoma patients.
Acronym
Relationship between ocular blood flow and structure-function in glaucoma patients.
Scientific Title
Relationship between ocular blood flow and structure-function in glaucoma patients.
Scientific Title:Acronym
Relationship between ocular blood flow and structure-function in glaucoma patients.
Region
| Japan |
Condition
Condition
Open angle glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the feature of ocular blood flow in open angle glaucoma.
Basic objectives2
Others
Basic objectives -Others
To evaluate the factors related to ocular blood flow in open angle glaucoma.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To determine the feature of ocular blood flow among healthy subjects, primary open angle glaucoma, normal tension glaucoma patients.
Key secondary outcomes
To compare patients backgrounds (age, gender, blood pressure, visual acuity, corneal curve, reflation, axial length, intra-ocular pressure, visual field sensitivity, perfusion density, retinal nerve fiber thickness, ganglion cell layer thickness, BMI, family history, smoking history) among healthy subjects, primary open angle glaucoma, normal tension glaucoma patients.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Mydriasis for LSFG imaging
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients with glaucoma who did not meet exclusion criteria.
Key exclusion criteria
1. visual acuity is less than 0.5.
2. refractive error is outside of +/- 6 diopter and cylinder is outside of +/- 2 diopter.
3. Axial length is more than 26.5mm.
4. Participants who have corneal opacity or cataract with Grade III of Emery-Little criteria.
5. False positive, falde negative, and fixation loss is more than 30%.
6. Participants who have experienced ocular surgery except for cataract (include multi fourcal IOL).
7. Participants who have experienced refractive surgery.
8. Participants who have experienced retinal, vitreous and choroidal disease,
9. Participants who have experienced cardiovascular condition or diabetes.
10. Systolic blood pressure at rest is more than 150mmHg or diastolic blood pressure at rest is more than 90mmHg.
11. Participants who have medicines related to ocular blood flow such as calcium blocker, alpha-1 blocker, beta-1 blocker, and PDE5 inhibitor agent.
12. Participants who have allergy for pupil dilation drops.
13. Participants who don't response to pupil dilation drops.
Target sample size
308
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Shoji |
Organization
Kitasato University School of medicine
Division name
Department of Ophthalmology
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
0427788464
nshoji@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazunori |
| Middle name | Hirasawa |
| Last name | Hirasawa |
Organization
Kitasato University School of medicine
Division name
Department of Ophthalmology
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
0427788464
Homepage URL
hirasawa@kitasato-u.ac.jp
Sponsor or person
Institute
Japanese Glaucoma Society
Institute
Department
Personal name
Funding Source
Organization
Japanese Glaucoma Society and Self Founding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University School of Medicine and Hospital, Ethical committee,
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel
042-778-8273
rinrib@med.kitasato-u.ac.jp
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
| 2020 | Year | 06 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
non
Management information
Registered date
| 2020 | Year | 03 | Month | 02 | Day |
Last modified on
| 2020 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045006
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| Registered date | File name |
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