UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058188 |
|---|---|
| Receipt number | R000066478 |
| Scientific Title | Retinal blood flow testing for physiological load in healthy adults |
| Date of disclosure of the study information | 2025/06/16 |
| Last modified on | 2025/06/16 12:19:53 |
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Basic information
Public title
Retinal blood flow testing for physiological load in healthy adults
Acronym
Retinal blood flow testing for physiological load
Scientific Title
Retinal blood flow testing for physiological load in healthy adults
Scientific Title:Acronym
Retinal blood flow testing for physiological load
Region
| Japan |
Condition
Condition
Diabetic retinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Retinal circulatory disorders such as diabetic retinopathy cause serious visual impairment, but a noninvasive and quantitative method to evaluate retinal circulatory control function has not been established. In this study, we aim to capture changes in ocular blood flow when systemic blood pressure is increased in a physiological stress test, and to apply it clinically as a new stress test.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Laser speckle flowography (LSFG) will be used to evaluate resting retinal blood flow, retinal blood flow every 4 seconds during 1 minute of 8 Hz flicker stimulation, and retinal blood flow every 4 seconds during 1 minute after the end of flicker stimulation.
Similarly, LSFG will be used to evaluate resting retinal blood flow, retinal blood flow every minute during 5 minutes of exercise with 2-3 kg dumbbells, and retinal blood flow after the end of exercise.
Ocular perfusion pressure and retinal blood flow changes during each loading test from rest will be compared.
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
(1) Measurement of mean blood pressure by arm insertion sphygmomanometer
(2) Measurement of intraocular pressure by non-contact tonometer
(3) Mydriasis by a single tropicamide eye drop
(4) Oxybuprocaine hydrochloride eye drop every 5 minutes for 3 times to suppress blinking against light stimulus
(5) Wait in a dark room for 15 minutes
(6) Measurement of resting retinal blood flow by laser speckle flowography (LSFG) (6) Measure the resting retinal blood flow using laser speckle flowgraphy (LSFG) (average of 3 measurements)
(7) Measure the retinal blood flow every 4 seconds for 1 minute during 8Hz flicker stimulation using LSFG
(8) Measure the retinal blood flow every 4 seconds for 1 minute after the end of 8Hz flicker stimulation using LSFG
(9) After resting for 1 hour, lift a 2-3 kg dumbbell and measure systemic blood pressure every 1 minute. (ix) After one hour of rest, measure systemic blood pressure every minute by lifting a 2-3 kg dumbbell, and measure ocular blood flow with LSFG for 5 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Persons 18 years of age or older without diabetic disease
Key exclusion criteria
1) Patients with a history of diabetes, hypertension, or dyslipidemia
2) Patients who are taking medication
3) Those with a history of smoking
4) Those with a history of eye disease and in the process of treatment.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Taiji |
| Middle name | |
| Last name | Nagaoka |
Organization
Asahikawa Medical University
Division name
Department of Ophthalmology
Zip code
0788510
Address
2-1-1-1 Midorigaoka-Higashi, Asahikawa, Hokkaido, 078-8510, Japan
TEL
0166682543
ganka@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Taiji |
| Middle name | |
| Last name | Nagaoka |
Organization
Asahikawa Medical University
Division name
Department of Ophthalmology
Zip code
0788510
Address
2-1-1-1 Midorigaoka-Higashi, Asahikawa, Hokkaido, 078-8510, Japan
TEL
0166682543
Homepage URL
ganka@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Planning Section, Research and Scientific Information Division, Asahikawa Medical University
Address
2-1-1-1 Midorigaoka-Higashi, Asahikawa, Hokkaido, 078-8510, Japan
Tel
0166-68-2297
rs-kp.g@asahikawa-med.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
| 2025 | Year | 06 | 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
| 2025 | Year | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 06 | Month | 16 | Day |
Last modified on
| 2025 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066478
