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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040585
Receipt No. 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 2020/05/30

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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
Email 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
Email chikako.shirai@med.tohoku.ac.jp

Sponsor
Institute Department of Ophthalmology, Tohoku University Graduate School of Medicine
Institute
Department

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
Email 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
2020 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2021 Year 02 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
2020 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046320

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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