UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020640 |
|---|---|
| Receipt number | R000023821 |
| Scientific Title | Investigation of the etiology of central serous chorioretinopathy using en face OCT and indocyanine green angiography |
| Date of disclosure of the study information | 2016/02/10 |
| Last modified on | 2019/03/05 19:41:29 |
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Basic information
Public title
Investigation of the etiology of central serous chorioretinopathy using en face OCT and indocyanine green angiography
Acronym
Possible Etiologies of Central Serous Chorioretinopathy
Scientific Title
Investigation of the etiology of central serous chorioretinopathy using en face OCT and indocyanine green angiography
Scientific Title:Acronym
Possible Etiologies of Central Serous Chorioretinopathy
Region
| Japan |
Condition
Condition
Central Serous Chorioretinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the etiology of central serous chorioretinopathy using indocyanine green angiography and en face-OCT imaging.
Basic objectives2
Others
Basic objectives -Others
To clarify the etiology of eye disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare the abnormal areas in central serous chorioretinopathy using en face-OCT and indocyanine green angiography.
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
| 30 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with central serous chorioretinopathy.
Key exclusion criteria
Patients with polypoidal choroidal vasculopathy and age-related macular diseases, based on fluorescein angiography, indocyanine green angiography and OCT findings, were excluded.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ari Shinojima |
Organization
Nihon University School of Medicine
Division name
Division of Ophthalmology, Department of Visual Science
Zip code
Address
1-6, Surugadai, Kanda, Chiyoda-ku, Tokyo
TEL
03-3293-1711
shinojima.ari@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ari Shinojima |
Organization
Nihon University School of Medicine
Division name
Division of Ophthalmology, Department of Visual Science
Zip code
Address
1-6, Surugadai, Kanda, Chiyoda-ku, Tokyo
TEL
03-3293-1711
Homepage URL
shinojima.ari@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Hospital
Institute
Department
Personal name
Funding Source
Organization
Novartis Pharma (to A.S.)
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
Address
Tel
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
| 2016 | Year | 02 | Month | 10 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pubmed/27532435
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/27532435
Number of participants that the trial has enrolled
Results
All 25 CSC eyes and 13 contralateral eyes showed abnormal hypofluorescent areas on late-phase ICGA and hyperreflective areas on en-face OCT from BrM to the choriocapillaris, and these findings correlated with the abnormal areas (r = 0.9988; p < 0.001).
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
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design (Observational case series study).
We retrospectively studied all eyes of consecutive untreated patients at our Hospital, between April 2015 and December 2015.
Items investigated (We investigated the area of the abnormal portion on en face images and the area of the abnormal portion in angiography images.)
Management information
Registered date
| 2016 | Year | 01 | Month | 19 | Day |
Last modified on
| 2019 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023821
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
