UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040585 |
|---|---|
| Receipt number | R000046320 |
| Scientific Title | Epidemiological study to clarify the association between systemic drug use and the risk of glaucoma using Japanese claims data. |
| Date of disclosure of the study information | 2020/05/31 |
| Last modified on | 2023/12/01 12:27:05 |
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Basic information
Public title
Epidemiological study to clarify the association between systemic drug use and the risk of glaucoma using Japanese claims data.
Acronym
Epidemiological study of glaucoma patients using Japanese claims data.
Scientific Title
Epidemiological study to clarify the association between systemic drug use and the risk of glaucoma using Japanese claims data.
Scientific Title:Acronym
Epidemiological study of glaucoma patients using Japanese claims data.
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the association between systemic drug use and the risk of glaucoma using Japanese regional claims data.
Basic objectives2
Others
Basic objectives -Others
Pharmaco-epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
First day of exposure (systemic drug prescription) and event (topical glaucoma drug prescription or glaucoma diagnosis)
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 with newly prescribed systemic drug, newly prescribed topical glaucoma drug, and newly diagnosed glaucoma (defined as code H401, H409 in the ICD-10) using Japanese regional claims data between January 1, 2015 to December 21, 2017.
Key exclusion criteria
Patients who did not meet the inclusion criteria.
Target sample size
20000
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Tsuda |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL
022-717-7294
tsuda@oph.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Chikako |
| Middle name | |
| Last name | Shirai |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL
022-717-7294
Homepage URL
chikako.shirai@med.tohoku.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Health Administration and Policy, Tohoku University Graduate School of Medicine
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Tohoku University Graduate School of Medicine Ethics Committee
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
Tel
022-717-3867
med-kenkyo@grp.tohoku.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
| 2020 | Year | 05 | Month | 31 | 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
20000
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 12 | Month | 01 | Day |
Other
Other related information
Retrospective self-control study.
Using 3 years of the anonymized Japanese regional claims data in the National Health Insurance System (for self-employment) and the Latter-Stage Elderly Healthcare System (for people aged 75 or over) provided by Hokkaido National Health Insurance Organization in Japan, sequence symmetry analysis (SSA) will be used to evaluate the preceding/following time relationship between exposure (systemic drug prescription) and event (topical glaucoma drug prescription or glaucoma diagnosis) in patients with newly prescribed systemic drug (typical oral drugs for CV or CNS disease).
Furthermore, hypothesis, end points and extraction conditions will be confirmed as the subset study for the future study using Japanese nationwide claims data, stored in the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB).
Management information
Registered date
| 2020 | Year | 05 | Month | 29 | Day |
Last modified on
| 2023 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046320
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
