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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021638
Receipt No. R000024951
Scientific Title The study for early diagnosis of glaucoma and the detection of glaucomatous progression.
Date of disclosure of the study information 2016/04/01
Last modified on 2017/03/29

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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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