UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037878 |
|---|---|
| Receipt number | R000043183 |
| Scientific Title | Epidemiological study to clarify the risk factors leading to glaucoma surgery of glaucoma patient using DPC data. |
| Date of disclosure of the study information | 2019/08/31 |
| Last modified on | 2021/09/03 20:45:09 |
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Basic information
Public title
Epidemiological study to clarify the risk factors leading to glaucoma surgery of glaucoma patient using DPC data.
Acronym
Epidemiological study of glaucoma patients using DPC data.
Scientific Title
Epidemiological study to clarify the risk factors leading to glaucoma surgery of glaucoma patient using DPC data.
Scientific Title:Acronym
Epidemiological study of glaucoma patients using DPC data.
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the risk factors leading to glaucoma surgery of Japanese glaucoma patient using DPC data.
Basic objectives2
Others
Basic objectives -Others
Epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical background of patients (attribute information, hospitalization information, diagnosis information and prescription drug information using DPC data).
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 were diagnosed with glaucoma (defined as code H401, H409 in the ICD-10) based on "diagnosis with highest medical cost" using Form1 of DPC data between April 1, 2012 to March 31, 2018.
Key exclusion criteria
Patients who did not meet the inclusion criteria.
Target sample size
60000
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
| 2019 | Year | 08 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.rinri.med.tohoku.ac.jp/esct/Apply/show.aspx?TYPE=1&ID=19893
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/33781215/
Number of participants that the trial has enrolled
29599
Results
The factors associated with the increase in glaucoma surgery were having allergies, taking concomitant drugs including depression, ischemic heart disease and peptic ulcer, being diagnosed with primary open-angle glaucoma and longer length of stay in hospital. In contrast, the factors associated with the decrease in glaucoma surgery were having hypertension, taking hypertension drug, over 80 years old and female.
Results date posted
| 2021 | Year | 09 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age was 68 years and 55.6% were male, and most patients had a moderate BMI and a low CCI.
Participant flow
A total of 29,599 patients included in the analysis, 12,038 (40.7%) and 17,561 (59.3%) patients were in the glaucoma surgery and non-glaucoma surgery cohorts, respectively.
Adverse events
None.
Outcome measures
The risk factors associated with glaucoma surgery.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Retrospective cohort study.
To confirm the difference of the clinical background of patients according to having or not having undergone glaucoma surgery (defined as code 150335910 in the medical practice claim code) after the hospitalization with glaucoma, using 6 years of DPC data collected by the project for Health and Labor Sciences Research Grants (HLSRG).
Furthermore, about patients who had undergone glaucoma surgery, the difference of the clinical background of patients will be confirmed according to having or not having undergone cataract surgery.
Management information
Registered date
| 2019 | Year | 08 | Month | 31 | Day |
Last modified on
| 2021 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043183
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