UMIN-CTR Clinical Trial

Basic information
Public title	Retrospective study for prediction of glaucoma progression
Acronym	Retrospective study for prediction of glaucoma progression
Scientific Title	Retrospective study for prediction of glaucoma progression
Scientific Title:Acronym	Retrospective study for prediction of glaucoma progression
Region	Japan

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

Objectives
Narrative objectives1	To investigate prediction of glaucoma progression in Japanese patients
Basic objectives2	Others
Basic objectives -Others	Progression of visual field loss
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Progression of visual field loss
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 Fukuiken Saiseikai Hospital during the survey period
Key exclusion criteria	Not applicable
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Koji Middle name Last name Nitta
Organization	Fukuiken Saiseikai Hospital
Division name	Ophthalmology
Zip code	918-8503
Address	Funabashi 7-1, Wadanaka-cho, Fukui City, Fukui
TEL	0776-23-1111
Email	k-nitta@fukui.saiseikai.or.jp

Public contact
Name of contact person	1st name Koji Middle name Last name Nitta
Organization	Fukuiken Saiseikai Hospital
Division name	Ophthalmology
Zip code	918-8503
Address	Funabashi 7-1, Wadanaka-cho, Fukui City, Fukui
TEL	0776-23-1111
Homepage URL
Email	k-nitta@fukui.saiseikai.or.jp

Sponsor
Institute	Fukuiken Saiseikai Hospital
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	Fukuiken Saiseikai Hospital
Address	Funabashi 7-1, Wadanaka-cho, Fukui City, Fukui
Tel	0776-23-1111
Email	somuka@fukui.saiseikai.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	福井県済生会病院(福井県)/ Fukuiken Saiseikai Hospital(Fukui Pref.)

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 16 Day

Related information
URL releasing protocol	Not applicable
Publication of results	Published

Result
URL related to results and publications	https://www.nature.com/articles/s41598-017-15267-y , https://doi.org/10.2147/OPTH.S247618
Number of participants that the trial has enrolled	312
Results	Refer to published paper
Results date posted	2020 Year 12 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2017 Year 11 Month 08 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	2015 Year 05 Month 18 Day
Date of IRB	2015 Year 05 Month 18 Day
Anticipated trial start date	2015 Year 05 Month 26 Day
Last follow-up date	2015 Year 10 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective study Prediction of Glaucoma progression Target sample size : No. of the target patients during the survey period

Management information
Registered date	2015 Year 06 Month 15 Day
Last modified on	2020 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020741