UMIN-CTR Clinical Trial

Basic information
Public title	Factual investigation on glaucoma
Acronym	Factual investigation on glaucoma
Scientific Title	Factual investigation on glaucoma
Scientific Title:Acronym	Factual investigation on glaucoma
Region	Japan

Condition
Condition	Glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Factual investigation based on analysis and data collected from patients with primary open angle glaucoma
Basic objectives2	Others
Basic objectives -Others	To examine the factors associated with glaucoma
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The factor which participates in glaucoma
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who visit Yoshikawa Eye Clinic twice or more with at least one eye meets all the following criteria are included in this study. 1. Diagnosed as open angle glaucoma 2. First visit to this clinic was at age of 20 or older
Key exclusion criteria	Not applicable
Target sample size	400

Research contact person
Name of lead principal investigator	1st name 1. Keiji Yoshikawa Middle name Last name 2. Masayo Hashimoto
Organization	1. Yoshikawa Eye Clinic 2. Santen Pharmaceutical Co., Ltd.
Division name	1. Yoshikawa Eye Clinic 2. Japan Medical Affairs Medical Affairs Global R&D
Zip code	1.194-0021 2.530-0011
Address	1. 1-3-1 Nakamachi, Machida, Tokyo 2. 4-20 Ohukacho, Kitaku, Osaka
TEL	042-739-0781
Email	yoshi0781.auge@gmail.com

Public contact
Name of contact person	1st name Keiji Middle name Last name Yoshikawa
Organization	Yoshikawa Eye Clinic
Division name	Yoshikawa Eye Clinic
Zip code	194-0021
Address	1-3-1 Nakamachi, Machida, Tokyo
TEL	042-739-0781
Homepage URL
Email	yoshi0781.auge@gmail.com

Sponsor
Institute	Yoshikawa Eye Clinic
Institute
Department

Funding Source
Organization	Santen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyoyukai RiverSide Clinic
Address	2-1 Minami 7 Jo Nishi, Chuoku, Sapporo, Hokkaido
Tel	011-521-2321
Email	rinrishinsa@riversideclinic.or.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	吉川眼科クリニック(東京都)/ Yoshikawa Eye Clinic(Tokyo)

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 18 Day

Related information
URL releasing protocol	Not applicable
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.2147/OPTH.S146455 , https://doi.org/10.2147/OPTH.S172273
Number of participants that the trial has enrolled	311
Results	Refer to published paper
Results date posted	2022 Year 05 Month 24 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2018 Year 01 Month 31 Day
Baseline Characteristics	Refer to published paper
Participant flow	Refer to published paper
Adverse events	Refer to published paper
Outcome measures	Refer to published paper
Plan to share IPD	The datasets are not publicly available, but are available from the corresponding author on reasonable request.
IPD sharing Plan description	The datasets are not publicly available, but are available from the corresponding author on reasonable request.

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 11 Day
Date of IRB	2016 Year 04 Month 26 Day
Anticipated trial start date	2016 Year 05 Month 19 Day
Last follow-up date	2019 Year 06 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This is a retrospective study using data from an institution for the factual investigation of glaucoma. Data from patients who visited Yoshikawa Eye Clinic from April 2006 to March 2016 and met all the inclusion criteria are collected and analyzed for the investigation.

Management information
Registered date	2016 Year 05 Month 17 Day
Last modified on	2022 Year 05 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025742