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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020640
Receipt No. 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

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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
Email 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
Email shinojima.ari@nihon-u.ac.jp

Sponsor
Institute Nihon University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.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


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