UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012411 |
|---|---|
| Receipt number | R000014465 |
| Scientific Title | A prospective observational study of structure and visual field progression in open-angle glaucoma |
| Date of disclosure of the study information | 2013/11/29 |
| Last modified on | 2022/03/10 16:00:48 |
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Basic information
Public title
A prospective observational study of structure and visual field progression in open-angle glaucoma
Acronym
A prospective observational study of structure and visual field progression in open-angle glaucoma
Scientific Title
A prospective observational study of structure and visual field progression in open-angle glaucoma
Scientific Title:Acronym
A prospective observational study of structure and visual field progression in open-angle glaucoma
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate progression and correlation of structure and visual field in glaucoma patients
Basic objectives2
Others
Basic objectives -Others
Structure and visual field progression
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MD
Retinal nerve fiber layer
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
Subject who is willing to follow instruction, and has provided a written informed consent
Diagnosis of open-angle glaucoma with glaucomatous visual field disorder in at least one eye
In both eyes, gonioscopy grading of 3 or 4 in Shaffer classification
Key exclusion criteria
Subject who has a disease which considered inappropriate from safety perspective(severe cardiovascular/ respiratory/ hepatobiliary/ digestive/ urinary/ renal/ hematological/ endocrine/ immune disease, malignant tumor, etc.)
The investigator, subinvestigator determined that the person is ineligible as study subject
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Hidenobu |
| Middle name | |
| Last name | Tanihara |
Organization
Faculty of Life Science,
Kumamoto University
Division name
Department of Ophthalmology
Zip code
860-8556
Address
1-1-1, Honjo Chuo-ku Kumamoto Japan
TEL
096-373-5247
tanihara@pearl.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | Kawata |
Organization
Santen Pharmaceutical CO., LTD.
Division name
Clinical Development Group
Zip code
530-8552
Address
4-20, Ofukacho Kita-ku Osaka Japan
TEL
06-4802-9338
Homepage URL
clinical@santen.co.jp
Sponsor or person
Institute
Santen Pharmaceutical CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
Santen Pharmaceutical CO., 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
Kumamoto University CCR Review Board
Address
1-1-1, Honjo Chuo-ku Kumamoto Japan
Tel
096-373-5965
byi-senshin@jimu.kumamoto-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
| 2013 | Year | 11 | Month | 29 | Day |
Related information
URL releasing protocol
Not applicable
Publication of results
Published
Result
URL related to results and publications
Not applicable
Number of participants that the trial has enrolled
119
Results
The analysis included 195 eyes of 115 patients [41 eyes in POAG (narrow) and 154 eyes in normal tension glaucoma (NTG)], 32 eyes in DH group, 10 eyes in migraine group, and 19 eyes in diabetic group. The mean IOP and mean MD of all groups at baseline were 13.3 plus or minus 2.2 mmHg and -6.4 plus or minus4.0 dB, respectively; the DH group had a greater proportion of NTG than the group without risk factors, but there was no significant difference in the degree of visual field impairment.
Results date posted
| 2022 | Year | 03 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Not applicable due to observational study
Participant flow
Not applicable due to observational study
Adverse events
Not applicable due to observational study
Outcome measures
Not applicable due to observational study
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2010 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective observational study
Management information
Registered date
| 2013 | Year | 11 | Month | 27 | Day |
Last modified on
| 2022 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014465
