UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055279 |
|---|---|
| Receipt number | R000063165 |
| Scientific Title | Pathology of age-related macular degeneration and pachychoroid-related diseases using adaptive optics optical coherence tomography |
| Date of disclosure of the study information | 2024/08/19 |
| Last modified on | 2024/08/19 18:49:34 |
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Basic information
Public title
Pathology of age-related macular degeneration and pachychoroid-related diseases using adaptive optics optical coherence tomography
Acronym
Pathology of age-related macular degeneration and pachychoroid using AO-OCT
Scientific Title
Pathology of age-related macular degeneration and pachychoroid-related diseases using adaptive optics optical coherence tomography
Scientific Title:Acronym
Pathology of age-related macular degeneration and pachychoroid using AO-OCT
Region
| Japan |
Condition
Condition
age-related macular degeneration and pachychoroid-related diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to investigate pathological changes of photoreceptor cell body, Muller cells, and subretinal deposits using AO-OCT.
Basic objectives2
Others
Basic objectives -Others
Relationship between photoreceptor cell body/subretinal deposits and choroidal neovascularization, geographic atrophy, soft drusen, calcified drusen, and SNPs.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences between age-related macular degeneration and pachychorid-related diseases.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with age-related macular degeneration and pachychoroid-related diseases.
Key exclusion criteria
Patients with other ocular diseases.
Eyes with poor image quality.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Sotaro |
| Middle name | |
| Last name | Ooto |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Sciences
Zip code
606-8507
Address
54 Kawahara-cho Shogoin Sakyo-ku Kyoto, Japan
TEL
075-751-3248
ohoto@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Sotaro |
| Middle name | |
| Last name | Ooto |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Sciences
Zip code
606-8507
Address
54 Kawahara-cho Shogoin Sakyo-ku Kyoto, Japan
TEL
075-751-3248
Homepage URL
ohoto@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethnics Commitee
Address
54 Kawahara-cho Shogoin Sakyo-ku Kyoto, Japan
Tel
075-751-4748
ctsodan@kuhp.kyoto-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
| 2024 | Year | 08 | Month | 19 | 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
| 2024 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 19 | 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
Observation of retinal microstructures using adaptive optics optical coherence tomography.
Management information
Registered date
| 2024 | Year | 08 | Month | 19 | Day |
Last modified on
| 2024 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063165
