UMIN-CTR Clinical Trial

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043183