UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040294 |
|---|---|
| Receipt number | R000045972 |
| Scientific Title | Evaluation of retinal vascular function in patients with vitreoretinal disorders |
| Date of disclosure of the study information | 2020/05/10 |
| Last modified on | 2020/05/02 13:47:30 |
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Basic information
Public title
Evaluation of retinal vascular function in patients with vitreoretinal disorders
Acronym
Evaluation of retinal vascular function
Scientific Title
Evaluation of retinal vascular function in patients with vitreoretinal disorders
Scientific Title:Acronym
Evaluation of retinal vascular function
Region
| Japan |
Condition
Condition
Diabetic retinopathy, Retinal vein occulusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate neurovascular function in the retina by flicker-induced increase in ocular blood flow and exmaine whether this examination may be useful for the prediction and prevention of these diseases.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The response of ocular blood flow in response to the flicker-stimulation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Flicker-stimulation (12 Hz, 3 minutes)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with retinal vascular disorders
Key exclusion criteria
Poor visual acuity, past ocular surgery, poor glycemic control
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | TAIJI |
| Middle name | |
| Last name | NAGAOKA |
Organization
Nihon University School of Medicine
Division name
Division of Ophthalmology, Department of Visual Sciences
Zip code
173-8610
Address
30-1 Oyaguchi-Kamicho, Itabashi-ku, Tokyo
TEL
03-3972-8111
taijinagaoka@gmail.com
Public contact
Name of contact person
| 1st name | TAIJI |
| Middle name | |
| Last name | NAGAOKA |
Organization
Nihon University School of Medicine
Division name
Division of Ophthalmology, Department of Visual Sciences
Zip code
173-8610
Address
30-1 Oyaguchi-Kamicho, Itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
taijinagaoka@gmail.com
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University IRB
Address
30-1 Oyaguchi-Kamicho, Itabashi-ku, Tokyo
Tel
03-3972-8111
komoda.nozomi@nihon-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 | 05 | Month | 10 | 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
| 2020 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 02 | Day |
Last modified on
| 2020 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045972
