UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036335 |
|---|---|
| Receipt number | R000041393 |
| Scientific Title | Creating the database of cataract surgery cases |
| Date of disclosure of the study information | 2019/03/29 |
| Last modified on | 2019/10/03 10:09:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Creating the database of cataract surgery cases
Acronym
the cataract surgery database
Scientific Title
Creating the database of cataract surgery cases
Scientific Title:Acronym
the cataract surgery database
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the efficacy and safety of cataract surgery in Keio University Hospital and joint research facilities by collecting the cataract surgery-related data as big data.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy and risk of complications of cataract surgery
Key secondary outcomes
past history, preoperative visual acuity, postoperative visual acuity, postoperative complications
term for evaluation: preoperative day, postoperative 1-6 days, postoperative 7-60 days
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
The patients underwent cataract surgery in our hospital and joint research facility who obtained the consent in this study.
Key exclusion criteria
Among the patients, those not obtained consent in this study.
Target sample size
20000
Research contact person
Name of lead principal investigator
| 1st name | Kazuno |
| Middle name | |
| Last name | Negishi |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
kazunonegishi@keio.jp
Public contact
Name of contact person
| 1st name | Yasuyo |
| Middle name | |
| Last name | Nishi |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
yasuyon@a2.keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology of Keio University School of Medicine
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
Research Ethics Committee of Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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 | 03 | Month | 29 | 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
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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Receiving the clinical information (medical record information, image information, questionnaires, etc.) from patients who underwent cataract surgery in our hospital and joint research facilities, we register the data in the entry form on the web and analyze the data using statistical methods.
Management information
Registered date
| 2019 | Year | 03 | Month | 29 | Day |
Last modified on
| 2019 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041393
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
