UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056385 |
|---|---|
| Receipt number | R000064422 |
| Scientific Title | Molecular pathology of diseases causing visual impairment |
| Date of disclosure of the study information | 2024/12/07 |
| Last modified on | 2026/01/23 11:32:10 |
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Basic information
Public title
Molecular pathology of diseases causing visual impairment
Acronym
Molecular pathology of diseases causing visual impairment
Scientific Title
Molecular pathology of diseases causing visual impairment
Scientific Title:Acronym
Molecular pathology of diseases causing visual impairment
Region
| Japan |
Condition
Condition
All diseases that cause visual impairment and require ophthalmic surgery (representative diseases include retinal detachment, proliferative vitreous retinopathy, diabetic retinopathy, macular hole, epiretinal macular membrane, and vitreous hemorrhage)
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to collect samples from patients with all diseases that cause visual impairment and require ophthalmic surgery (representative diseases include retinal detachment, proliferative vitreous retinopathy, diabetic retinopathy, macular hole, epiretinal macular membrane, and vitreous hemorrhage) without any additional invasion during surgery, and to perform omics analyses such as mRNA analysis and protein analysis, in order to use the results in the development of future treatments and prevention methods.
Basic objectives2
Others
Basic objectives -Others
Omics analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Biochemical information (metabolic information)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who visited the institutions participating in this study for the purpose of examination and treatment for the target disease and gave their consent
Key exclusion criteria
Patients who did not give consent
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Kaneko |
Organization
Hamamatsu university school of medicine
Division name
ophthalmology
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka, 431-3192, Japan
TEL
053-435-2256
h-kaneko@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kaoruko |
| Middle name | |
| Last name | Torii |
Organization
Hamamatsu university school of medicine
Division name
ophthalmology
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka, 431-3192, Japan
TEL
053-435-2256
Homepage URL
kaorukot@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu university school of medicine
Institute
Department
Personal name
Hiroki Kaneko
Funding Source
Organization
Ministry of education, culture, sports, science and technology
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
Hamamatsu University School of Medicine, Life Science and Medical Research Ethics Committee
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka, 431-3192, Japan
Tel
053-435-2680
rinri@hama-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
| 2024 | Year | 12 | Month | 07 | 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 | 09 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Samples are taken and stored during surgery from patients with all diseases that cause visual impairment and require ophthalmic surgery (representative diseases include retinal detachment, proliferative vitreous retinopathy, diabetic retinopathy, macular hole, epiretinal macular membrane, and vitreous hemorrhage). Normally, these specimens would be discarded during surgery, but these samples are preserved to prepare pathological specimens, and to extract and preserve proteins and mRNA. In addition, oxygen saturation, electrolyte concentration, pH, etc. are measured. The samples obtained are compared by disease and used to develop future treatments and prevention methods.
Management information
Registered date
| 2024 | Year | 12 | Month | 06 | Day |
Last modified on
| 2026 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064422
