UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014796 |
|---|---|
| Receipt number | R000016155 |
| Scientific Title | Retrospective study using Ocular Response Analyzer(ORA) to clarify patient's condition of glaucoma |
| Date of disclosure of the study information | 2014/08/08 |
| Last modified on | 2019/02/15 14:12:20 |
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Basic information
Public title
Retrospective study using Ocular Response Analyzer(ORA) to clarify patient's condition of glaucoma
Acronym
Retrospective study using Ocular Response Analyzer(ORA) to clarify patient's condition of glaucoma
Scientific Title
Retrospective study using Ocular Response Analyzer(ORA) to clarify patient's condition of glaucoma
Scientific Title:Acronym
Retrospective study using Ocular Response Analyzer(ORA) to clarify patient's condition of glaucoma
Region
| Japan |
Condition
Condition
Glaucoma, Glaucoma suspect, Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine corneal biomechanical properties by Ocular Response Analyzer (ORA), and investigate the relationship between intraocular pressure, retinal nerve fiber layer and visual field in glaucoma patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
･Age
･Gender
･Distant Visual Acuity
･Spherical equivalent(Refractive value)
･Corneal Topography(Corneal radius, Corneal refraction, Corneal astigmatism)
･Intraocular Pressure
･Visual field: Humphrey Field Analyzer
･Thickness of 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
･Normal eye
･Cataract eye
･Glaucoma eye
･Glaucoma suspect eye
Key exclusion criteria
Those patients who underwent ophthalmic operation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Morita |
Organization
Faculty of Medicine, Kitasato University
Division name
Department of Ophthalmology
Zip code
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa Japan
TEL
042-778-8464
tamosace@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Morita |
Organization
Kitasato University Hospital
Division name
Department of Ophthalmology
Zip code
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa Japan
TEL
042-778-8464
Homepage URL
tamosace@gmail.com
Sponsor or person
Institute
Department of Ophthalmology,
Kitasato University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
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
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
北里大学病院（神奈川県） Kitasato University Hospital(Kanagawa)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 08 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
cancellation
Management information
Registered date
| 2014 | Year | 08 | Month | 08 | Day |
Last modified on
| 2019 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016155
