UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038007 |
|---|---|
| Receipt number | R000043325 |
| Scientific Title | Analysis of morphological characteristics of choroidal structure in central serous chorioretinopathy. |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2022/03/17 01:27:15 |
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Basic information
Public title
Analysis of morphological characteristics of choroidal structure in central serous chorioretinopathy.
Acronym
Choroidal structure in central serous chorioretinopathy.
Scientific Title
Analysis of morphological characteristics of choroidal structure in central serous chorioretinopathy.
Scientific Title:Acronym
Choroidal structure in central serous chorioretinopathy.
Region
| Japan |
Condition
Condition
central serous chorioretinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The charactaristics of choroidal structure of central serous chorioretinopathy are observed in detail by multiple ophthalmic examinations such as optical coherence tomography and optical coherence tomography angiography.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sex, age, visual acuity, visual field, refraction, ocular axial length, fundus observation,Optical coherence tomography, optical coherence tomography angiography, fundus photograph, fluorescence fundus angiography, slit lamp microscopy, duration of disease, current medical history, past history, family history
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Treatment naive central serous chorioretinopathy
Key exclusion criteria
Patients who pre- and post-operative imaging examinations cannot be performed.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | jun |
| Middle name | |
| Last name | takeuchi |
Organization
Nagoya University Hospital
Division name
Department of Ophthalmology
Zip code
466-0065
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2275
takeuchi.jun@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | takeuchi |
| Middle name | |
| Last name | jun |
Organization
Nagoya University Hospital
Division name
Department of Ophthalmology
Zip code
466-0065
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2275
Homepage URL
takeuchi.jun@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
052-744-2275
ethics@med.nagoya-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
| 2019 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
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 | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2019 | Year | 09 | Month | 13 | Day |
Last modified on
| 2022 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043325
