UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053866 |
|---|---|
| Receipt number | R000061488 |
| Scientific Title | Assessment of the Utility of Goggle-Type Contrast Sensitivity Measurement Device |
| Date of disclosure of the study information | 2024/03/15 |
| Last modified on | 2024/03/14 18:09:04 |
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Basic information
Public title
Assessment of the Utility of Goggle-Type Contrast Sensitivity Measurement Device
Acronym
Assessment of the Utility of Goggle-Type Contrast Sensitivity Measurement Device
Scientific Title
Assessment of the Utility of Goggle-Type Contrast Sensitivity Measurement Device
Scientific Title:Acronym
Assessment of the Utility of Goggle-Type Contrast Sensitivity Measurement Device
Region
| Japan |
Condition
Condition
Cases of cataracts or suspected cataracts
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison between Contrast Sensitivity Measurement Results Using a new Contrast Sensitivity Measurement Device and Those Using Existing Contrast Sensitivity Measurement Devices
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Contrast sensitivity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
As a pre-examination preparation, obtain information on the date of birth, gender, visual acuity, and refractive power. Subsequently, perform contrast sensitivity measurements once or multiple times using existing contrast sensitivity devices and a new contrast sensitivity measurement device.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
a. cataract patient
b. Age of 18 years or more
c. Patients who can agree to participate, in his/her own intention
Key exclusion criteria
None
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shirou |
| Middle name | |
| Last name | Kawasaki |
Organization
KAWASAKI EYE CLINIC
Division name
-
Zip code
791-8065
Address
1-1 Misugi-cho, Matsuyama City, Ehime Prefecture, Japan
TEL
089-951-6110
kawasaki.eye.clinic@ray.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Shirou |
| Middle name | |
| Last name | Kawasaki |
Organization
KAWASAKI EYE CLINIC
Division name
-
Zip code
791-8065
Address
1-1 Misugi-cho, Matsuyama City, Ehime Prefecture, Japan
TEL
089-951-6110
Homepage URL
kawasaki.eye.clinic@ray.ocn.ne.jp
Sponsor or person
Institute
KAWASAKI EYE CLINIC
Institute
Department
Personal name
Funding Source
Organization
FINDEX Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
FINDEX Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
FINDEX Inc. Research Ethics Committee
Address
26F Tokyo Sankei Building, 1-7-2 Otemachi, Chiyoda-ku, Tokyo
Tel
03-6271-8958
qms@findex.co.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
| 2024 | Year | 03 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 14 | Day |
Last modified on
| 2024 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061488
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
