UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038063 |
|---|---|
| Receipt number | R000043388 |
| Scientific Title | Investigation of the Etiology in Retinal Pigment Epithelium of Macular Diseases |
| Date of disclosure of the study information | 2020/07/10 |
| Last modified on | 2021/02/17 23:12:04 |
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Basic information
Public title
Investigation of the Etiology of Eye Diseases
Acronym
Investigation of the Eye Diseases
Scientific Title
Investigation of the Etiology in Retinal Pigment Epithelium of Macular Diseases
Scientific Title:Acronym
Investigation of the Macular Diseases
Region
| Japan |
Condition
Condition
Macular diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we clarify that the retinal pigment epithelium disorder of macular area using short- and long-wavelength autofluorescence, and optical coherence tomography.
Basic objectives2
Others
Basic objectives -Others
Serous retinal detachment, bleeding, Bruch's membrane deposit
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of abnormality of retinal pigment epithelium
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
| 25 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients who visited the university facility for examination for macular disease during the period were eligible for this study.If patient consent is obtained, they will be enrolled in this study.
Key exclusion criteria
Patients with iodine allergy or fluorescein allergy. Patients who have not obtained consent for this study.
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Ari |
| Middle name | |
| Last name | Shinojima |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku
TEL
+81-3-5363-3204
ari.shinojima@keio.jp
Public contact
Name of contact person
| 1st name | Ari |
| Middle name | |
| Last name | Shinojima |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku
TEL
+81-3-5363-3204
Homepage URL
ari.shinojima@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
JSPS
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
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku
Tel
+81-3-5363-3204
ari.shinojima@keio.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
| 2020 | Year | 07 | Month | 10 | 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
22
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
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 11 | Day |
Date of closure to data entry
| 2021 | Year | 02 | Month | 11 | Day |
Date trial data considered complete
| 2021 | Year | 02 | Month | 11 | Day |
Date analysis concluded
| 2021 | Year | 02 | Month | 11 | Day |
Other
Other related information
Observational Study
Management information
Registered date
| 2019 | Year | 09 | Month | 20 | Day |
Last modified on
| 2021 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043388
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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