UMIN-CTR Clinical Trial

Basic information
Public title	Advanced glaucoma study
Acronym	AGS
Scientific Title	Advanced glaucoma study
Scientific Title:Acronym	AGS
Region	Japan

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

Objectives
Narrative objectives1	Observasional study about the prognosis advanced glaucoma in Japanese subject.
Basic objectives2	Others
Basic objectives -Others	Observasional study
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	loss of visual acuity visual field defect
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	Glaucoma patients without clinically significant eye disease which might affect examination of the visual field and whose mean deviation of Humphrey Field Analyzer (HFA) 24-2 program is -20dB or worse.
Key exclusion criteria	Patients are excluded in the following conditions, (1) examination of visual field is not reliable (fixation loss>20% or false-positive responses>15%), (2) corrected visual acuity is worse than 10/20.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Araie
Organization	Tokyo University Graduate School of Medicine, Tokyo, Japan
Division name	Department of Ophthalmology
Zip code	1138655
Address	7-3-1 Hongo, Bunkyoku, Tokyo, 113-8655 Japan
TEL	03-3812-2111
Email	araie-tky@umin.net

Public contact
Name of contact person	1st name Kenji Middle name Last name Sugisaki
Organization	Tokyo University Graduate School of Medicine, Tokyo, Japan
Division name	Department of Ophthalmology
Zip code	1138655
Address	7-3-1 Hongo, Bunkyoku, Tokyo, 113-8655 Japan
TEL	03-3812-2111
Homepage URL
Email	sugisak-tky@umin.ac.jp

Sponsor
Institute	Japan Glaucoma Society
Institute
Department

Funding Source
Organization	Japan Glaucoma Society
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	Tokyo University Graduate School of Medicine, Ethical Review Board
Address	7-3-1 Hongo, Bunkyoku, Tokyo, 113-8655 Japan
Tel	03-5800-8743
Email	abe@m.u-tokyo.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	2008 Year 02 Month 02 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	Completed
Date of protocol fixation	2004 Year 07 Month 22 Day
Date of IRB	2002 Year 06 Month 06 Day
Anticipated trial start date	2004 Year 07 Month 22 Day
Last follow-up date	2015 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 10 Month 25 Day

Other
Other related information	prospective study of background factors for advanced stage glaucoma.

Management information
Registered date	2008 Year 01 Month 31 Day
Last modified on	2021 Year 12 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001132