UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062125 |
|---|---|
| Receipt number | R000071090 |
| Scientific Title | Retinal Oxygen Saturation in Chorioretinal Diseases |
| Date of disclosure of the study information | 2026/07/02 |
| Last modified on | 2026/07/02 18:35:32 |
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Basic information
Public title
Retinal Oxygen Saturation in Chorioretinal Diseases
Acronym
ROSCD study
Scientific Title
Retinal Oxygen Saturation in Chorioretinal Diseases
Scientific Title:Acronym
ROSCD study
Region
| Japan |
Condition
Condition
chorioretinal disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will measure retinal tissue oxygen saturation using Zilia during fundus examinations in patients with abnormalities in the fundus, such as diabetic retinopathy, retinal vein occlusion, age-related macular degeneration, retinal detachment, epiretinal membrane, high myopia, and glaucoma. We will measure retinal oxygen saturation for each condition to estimate oxygen metabolism. We will also analyze the relationship between these parameters and disease severity. While previous measurements were limited to the large retinal vessels, the ability to now measure oxygen saturation in the retinal tissue itself allows us to elucidate in greater detail the impact of these conditions on retinal tissue oxygenation.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of Retinal Oxygen Saturation Between the Affected Eye and the Contralateral Eye
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
For patients diagnosed with choroidal diseases, the study details and participation requirements were explained using an informed consent form during the examination. For patients who provided consent, retinal tissue oxygen saturation was measured continuously three times in both the affected eye and the contralateral eye using Zilia. This was performed in the same manner as standard fundus photography.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age: 20 years or older
2) Gender: Any
3) Retinal and choroidal diseases: Patients diagnosed with retinal and choroidal diseases based on examinations such as fundus examination, fluorescein angiography (FA), indocyanine green angiography (ICGA), or optical coherence tomography (OCT).
4) Patient Consent: Patients who, after receiving a thorough explanation regarding participation in this study and fully understanding it, provided written informed consent of their own free will.
5) Outpatients
Key exclusion criteria
1) Cases with severe corneal opacity, cataracts, or opacity of the intermediate transparent media
2) Cases in which both eyes are affected
Target sample size
420
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Suzuma |
Organization
Kagawa University
Division name
Ophthalmology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kida-Gun, Kagawa Prefecture
TEL
087-891-5111
ganka-m@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Rie |
| Middle name | |
| Last name | Osaka |
Organization
Kagawa University
Division name
Ophthalmology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kida-Gun, Kagawa Prefecture
TEL
087-891-5111
Homepage URL
ganka-m@kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
Funding Source
Organization
Kagawa University
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
Ethics Committee of the Faculty of Medicine, Kagawa University
Address
1750-1 Ikenobe, Miki-cho, Kida-Gun, Kagawa Prefecture
Tel
087-898-5111
chiken-m@kagawa-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
| 2026 | Year | 07 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2030 | 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
| 2026 | Year | 07 | Month | 02 | Day |
Last modified on
| 2026 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071090
