UMIN-CTR Clinical Trial

Basic information
Public title	A clinical study of the relation between 24-hour intraocular pressure and activities.
Acronym	The relation between 24h IOP and activities.
Scientific Title	A clinical study of the relation between 24-hour intraocular pressure and activities.
Scientific Title:Acronym	The relation between 24h IOP and activities.
Region	Japan

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

Objectives
Narrative objectives1	To investigate the relation between 24 hour activities and intra-ocular pressure with wearable activity monitor and with wearable intra-ocular pressure monitor.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To confirm between activities' changes and intra-ocular pressure's changes.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy subjects and glaucoma patients.
Key exclusion criteria	Cases of corneal erosion, corneal ulcer, signs of inflammatory eye disease. Cases of post glaucoma filtering surgery.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Ishikawa Middle name Last name Shinichiro
Organization	Saga university
Division name	Department of ophthalmology
Zip code	8498501
Address	Nabeshima 5-1, Saga city, Saga prefecture, Japan
TEL	0952-34-2384
Email	c1441@cc.saga-u.ac.jp

Public contact
Name of contact person	1st name Kimura Middle name Last name Shinya
Organization	Saga university
Division name	IRB
Zip code	8498501
Address	Nabeshima 5-1, Saga city, Saga prefecture, Japan
TEL	0952-34-2384
Homepage URL
Email	c1441@cc.saga-u.ac.jp

Sponsor
Institute	Saga university
Institute
Department

Funding Source
Organization	Saga university
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Saga university hospital
Address	Nabeshima 5-1, Saga city, Saga prefecture, Japan
Tel	0952343357
Email	c1441@cc.saga-u.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	2015 Year 07 Month 11 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
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	Open public recruiting
Date of protocol fixation	2015 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2015 Year 07 Month 12 Day
Last follow-up date	2016 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Activities' changes are corrected by Fitbit (Fitbit, SanFrancisco USA) and intra-ocular pressure's changes are corrected by Triggerfish(Sensimed, Lausanne Switzerland). Prospective, random sample study.

Management information
Registered date	2015 Year 07 Month 11 Day
Last modified on	2020 Year 07 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019103