UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058422 |
|---|---|
| Receipt number | R000066797 |
| Scientific Title | A Study of Illuminance and Choroidal Structure |
| Date of disclosure of the study information | 2025/07/15 |
| Last modified on | 2025/07/10 15:24:46 |
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Basic information
Public title
A Study of Illuminance and Choroidal Structure
Acronym
A Study of Illuminance and Choroidal Structure
Scientific Title
A Study of Illuminance and Choroidal Structure
Scientific Title:Acronym
A Study of Illuminance and Choroidal Structure
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate choroidal structural changes under the environment that contribute to myopia progression.
Basic objectives2
Others
Basic objectives -Others
To investigate the changes in choroidal structure induced by light and dark conditions.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To compare the ratio of choroidal vessels and interstitium under light and dark conditions.
Key secondary outcomes
To compare retinal and choroidal thicknesses under light and dark conditions.
To investigate factors involved in refraction and axial length.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Use of optical coherence tomography and optical biometry
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants who received a written explanation of the study's purpose and procedures, provided written informed consent.
Key exclusion criteria
Cases with ocular fundus diseases.
Cases in which image evaluation is not feasible due to poor image quality or artifacts.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Chisato |
| Middle name | |
| Last name | Otaki |
Organization
Shinseikai Toyama Hospital
Division name
Eye Center
Zip code
939-0243
Address
89-10 Shimowaka, Imizu City, Toyama Prefecture
TEL
0766-52-2156
c-ootaki@shinseikai.or.jp
Public contact
Name of contact person
| 1st name | Chisato |
| Middle name | |
| Last name | Otaki |
Organization
Shinseikai Toyama Hospital
Division name
Eye Center
Zip code
939-0243
Address
89-10 Shimowaka, Imizu City, Toyama Prefecture
TEL
0766-52-2156
Homepage URL
c-ootaki@shinseikai.or.jp
Sponsor or person
Institute
Shinseikai Toyama Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Research Ethics Committee of Shinseikai Toyama Hospital
Address
89-10 Shimowaka, Imizu City, Toyama Prefecture
Tel
0766-52-2156
rinri-jimu@shinseikai.or.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 | 07 | Month | 15 | 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 | 05 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | 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 | 07 | Month | 10 | Day |
Last modified on
| 2025 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066797
