UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053490 |
|---|---|
| Receipt number | R000061055 |
| Scientific Title | Survey of Ophthalmic Diseases in Tomiya City |
| Date of disclosure of the study information | 2024/01/31 |
| Last modified on | 2024/03/29 16:30:30 |
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Basic information
Public title
Survey of Ophthalmic Diseases in Tomiya City
Acronym
Survey of Ophthalmic Diseases in Tomiya City
Scientific Title
Survey of Ophthalmic Diseases in Tomiya City
Scientific Title:Acronym
Survey of Ophthalmic Diseases in Tomiya City
Region
| Japan |
Condition
Condition
Call for applicants to participate from Tomiya City employees.
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A small-scale survey of ophthalmologic diseases will be conducted as a preliminary study before conducting a cohort study of ophthalmologic diseases in Tomiya City.
To investigate practical visual functions such as contrast visual acuity, dynamic visual acuity, and visual field in a general healthy population, and to investigate the relationship with other ocular findings and cognitive functions.
We will also investigate the relationship with other ocular findings and cognitive function.
Basic objectives2
Others
Basic objectives -Others
The results of the ophthalmologic examination are used to compare patients with and without ocular diseases that cause visual dysfunction, and to analyze the comparisons and interrelationships among diseases and groups for each endpoint.
The results of the ophthalmologic examination will be used to compare patients with and without ocular diseases that cause visual dysfunction, and to analyze comparisons among diseases and groups and the interrelationships among variables for each endpoint.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
OCT, visual field testing, visual acuity testing (contrast visual acuity, dynamic visual acuity, etc.), and other ophthalmologic examination parameters.
Parameters obtained from various ophthalmologic examinations
Key secondary outcomes
Cognitive function tests and other subject background information
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. age 18 or older
2. Gender: Any gender
3. Persons who have given their written or electromagnetic consent to participate in the research.
Key exclusion criteria
Persons who are unable to obtain the person's written or electromagnetic consent
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Tsuda |
Organization
Tohoku University Hospital
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai , Miyagi , Japan
TEL
022-717-7294
tsuda@oph.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Tsuda |
Organization
Tohoku University Hospital
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai , Miyagi , Japan
TEL
022-717-7294
Homepage URL
tsuda@oph.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
JST
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai , Miyagi , Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
東北大学病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Small-scale fact-finding survey for future cohort study of ophthalmic diseases in Tomiya City.
Management information
Registered date
| 2024 | Year | 01 | Month | 31 | Day |
Last modified on
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061055
