UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031103 |
|---|---|
| Receipt number | R000035519 |
| Scientific Title | A retrospective multi-center case series study for posterior segment disease. |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2018/02/01 16:26:12 |
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Basic information
Public title
A retrospective multi-center case series study for posterior segment disease.
Acronym
Multi-center case series study for posterior segment disease.
Scientific Title
A retrospective multi-center case series study for posterior segment disease.
Scientific Title:Acronym
Multi-center case series study for posterior segment disease.
Region
| Japan |
Condition
Condition
Posterior segment disease.
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There are limited surgical cases only at own facility, but to secure sufficient sample size by multi-center
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual acuity
intraocular pressure
intraoperative complication
postoperative complication
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 need surgical treatment for posterior segment disease.
Key exclusion criteria
Patients who are not undergoing surgery treatment
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chie Sotozono |
Organization
Kyoto Prefectual Univercity of Medicine
Division name
Department of Ophthalmology
Zip code
Address
465 Kajii cho Hirokoji agaru Kawaramachi dori Kamigyo ku Kyoto
TEL
075-251-5578
csotozon@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoichiro Shinkai |
Organization
Kyoto Prefectual Univercity of Medicine
Division name
Department of Ophthalmology
Zip code
Address
465 Kajii cho Hirokoji agaru Kawaramachi dori Kamigyo ku Kyoto
TEL
075-251-5578
Homepage URL
yshinkai@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectual Univercity of Medicine, Department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectual Univercity of Medicine, Department of Ophthalmology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Ophthalmology, Oshima Eye Clinic, Takatsuki, Japan.
Department of Ophthalmology, Osaka city University Graduate School of Medicine, Osaka, Japan.
Department of Ophthalmology, Kobe University Graduate School of Medicine, Kobe, Japan.
Department of Ophthalmology, Jikei University School of Medicine, Tokyo, Japan.
Department of Ophthalmology, Marianna University School of Medicine, Kanagawa, Japan.
Department of Ophthalmology, Hyogo Prefectural Amagasaki General Medical Center, Hyogo, Japan.
Department of Ophthalmology, the Keiyu Hospital, Kanagawa, Japan.
Department of Ophthalmology, Fukui Red Cross Hospital, Fukui, Japan.
Department of Ophthalmology, the MIE Ganka, Yotsukaichi, Japan.
Department of Ophthalmology, Okanami General Hospital, Iga, Japan.
Department of Ophthalmology, the Mikawa Eye Clinic, Saga, Japan.
Department of Ophthalmology, Kozawa Eye Hospital and Diabetes Center, Mito Japan.
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
| 2018 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2017 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Presented in part at: the American Academy of Ophthalmology Annual Meeting, November 11-14, 2017, New Orleans, America.
Management information
Registered date
| 2018 | Year | 02 | Month | 01 | Day |
Last modified on
| 2018 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035519
