UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001004 |
|---|---|
| Receipt number | R000001132 |
| Scientific Title | Advanced glaucoma study |
| Date of disclosure of the study information | 2008/02/02 |
| Last modified on | 2021/12/24 11:28:49 |
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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
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
sugisak-tky@umin.ac.jp
Sponsor or person
Institute
Japan Glaucoma Society
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001132
