UMIN-CTR Clinical Trial

Basic information
Public title	The study for early diagnosis of glaucoma and the detection of glaucomatous progression.
Acronym	The study for early diagnosis of glaucoma.
Scientific Title	The study for early diagnosis of glaucoma and the detection of glaucomatous progression.
Scientific Title:Acronym	The study for early diagnosis of glaucoma.
Region	Japan

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

Objectives
Narrative objectives1	1) To establish methods for early diagnosis of glaucoma and detection of glaucomatous progression depending on the morphological clasification of the optic nerve head. 2) To apply the results to clinical use conbing with the database of glaucoma patients.
Basic objectives2	Others
Basic objectives -Others	Prospective, observation studies.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Value of clinical parameters collected at every visit when glaucoma progress.
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	The objects of this study are glaucoma patients and glacuoma suspects.This determination was made according to the recommendations of the Japan Glaucoma Society Guidelines for Glaucoma.All patients need to undergo clinical examination including observations of anterior chamber angle and optic disc and visual field test.Glaucoma is defined as a patient with visual field defects corresponding to the glaucomatous change of optic nerve head.Glaucoma suspect is defined as a patient with glaucomatous optic nerve head appearance without visual field defects.Informed consent is needed for entry.
Key exclusion criteria	1. When doctor determine an patint ineligible. 2. IOP is unmeasurable. 3. Ocular fundus is unobservable. 4. Informed consent can not be obtained due to cognitive deterioration. 5. Scheduled examinations can not be performed.
Target sample size	320

Research contact person
Name of lead principal investigator	1st name Middle name Last name Toru Nakazawa
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Ophthalmology
Zip code
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, JAPAN
TEL	0227177294
Email	ntoru@oph.med.tohoku.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yu Yokoyama
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Ophthalmology
Zip code
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, JAPAN
TEL	0227177294
Homepage URL
Email	yu-yokoyama@oph.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization	KOWA Company.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
Address
Tel
Email

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	2016 Year 04 Month 01 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 06 Month 05 Day
Date of IRB
Anticipated trial start date	2015 Year 06 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective, observation study. Patients is recruted from Jun, 2015 and clinical data is collected for 5 years.

Management information
Registered date	2016 Year 03 Month 27 Day
Last modified on	2017 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024951

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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