UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009842 |
|---|---|
| Receipt number | R000011534 |
| Scientific Title | Investigation of the performance of an automated perimeter with a normative database of Japanese population in glaucoma detection. |
| Date of disclosure of the study information | 2013/01/22 |
| Last modified on | 2017/11/26 22:01:00 |
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Basic information
Public title
Investigation of the performance of an automated perimeter with a normative database of Japanese population in glaucoma detection.
Acronym
Investigation of the performance of an automated perimeter with a normative database of Japanese population in glaucoma detection.
Scientific Title
Investigation of the performance of an automated perimeter with a normative database of Japanese population in glaucoma detection.
Scientific Title:Acronym
Investigation of the performance of an automated perimeter with a normative database of Japanese population in glaucoma detection.
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the performance of an automated perimeter with a normative database of Japanese population in glaucoma detection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare the abilities of a conventional perimeter and a perimeter which has a normative database of Japanese population to discriminate between healthy eyes and glaucomatous eyes.
Key secondary outcomes
To investigate the best parameter of a normative database of Japanese population for glaucoma detection in automated perimetry.
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
Glaucomatous abnormal eye
1) Abnormal glaucomatous appearance of the optic disc on simultaneous stereophotographs.
2) No other intraocular eye disease
3) Spherical refraction is within -6D to +3D. Cylinder correction is within -2.5D to +2.5D.
4) Corrected visual acuity >= 0.9
5) Subjects who agree to the participation in this study.
Normal eye
1) Normal optic disc on simultaneous stereophotographs.
2) No any intraocular eye disease
3) IOP <= 20 mmHg
4) Spherical refraction is within -6D to +3D. Cylinder correction is within -2.5D to +2.5D.
5) Corrected visual acuity >= 0.9
6) Subjects who agree to the participation in this study.
Key exclusion criteria
Glaucomatous abnormal eye
1) History of disease which affect the visual field sensitivity except glaucoma.
2) History of intraocular surgery.
3) History of medications which affect visual field sensitivity.
Normal eye
1) History of disease which affect the visual field sensitivity.
2) History of intraocular surgery.
3) History of medications which affect visual field sensitivity.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Sugiyama |
Organization
Kanazawa University
Division name
Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences
Zip code
Address
13-1 Takara-machi, Kanazawa city, Ishikawa Pref.
TEL
076-265-2403
eyeshin@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Ohkubo |
Organization
Kanazawa University
Division name
Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences
Zip code
Address
13-1 Takara-machi, Kanazawa city, Ishikawa Pref.
TEL
076-265-2403
Homepage URL
eyeshin@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Kowa company, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kinki University Faculty of Medicine / Department of Ophthalmology
Tajimi Iwase Eye Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
金沢大学付属病院（石川県）
近畿大学医学部附属病院（大阪府）
たじみ岩瀬眼科（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 12 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2013 | Year | 08 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Sensitivity and Specificity.
Management information
Registered date
| 2013 | Year | 01 | Month | 22 | Day |
Last modified on
| 2017 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011534
