UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063149 |
|---|---|
| Receipt number | R000072278 |
| Scientific Title | The Second Hirado-Takushima Eye Study: A Population-Based Longitudinal Epidemiological Study |
| Date of disclosure of the study information | 2026/10/02 |
| Last modified on | 2026/10/02 13:28:44 |
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Basic information
Public title
Population-Based Ophthalmic Screening in Taku-shima Island, Hirado, Japan
Acronym
The Second Hirado-Takushima Eye Study
Scientific Title
The Second Hirado-Takushima Eye Study: A Population-Based Longitudinal Epidemiological Study
Scientific Title:Acronym
Second Hirado-Takushima Eye Study
Region
| Japan |
Condition
Condition
Ocular diseases and ocular surface disorders, including meibomian gland dysfunction and dry eye disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to conduct ophthalmic screening among residents of Taku-shima Island, Hirado City, Nagasaki Prefecture, where no ophthalmologist is permanently available, to facilitate the early detection of ocular diseases and to promote awareness of eye health and ocular diseases.
Basic objectives2
Others
Basic objectives -Others
This is the second population-based ophthalmic screening conducted approximately seven years after the first screening in 2017, and longitudinal changes in ophthalmic findings will also be evaluated.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The prevalence of ocular and ocular surface diseases based on ophthalmic questionnaires and background characteristics, visual acuity, intraocular pressure, ocular surface parameters, fundus photography, and optical coherence tomography (OCT), as well as longitudinal changes in ophthalmic findings since the first screening conducted in 2017. In particular, the incidence of meibomian gland dysfunction (MGD) and factors associated with incident MGD will be evaluated.
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
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Residents aged 6 years or older living on Taku-shima Island, Hirado City, Nagasaki Prefecture, Japan, who provided informed consent to participate in the study themselves or through a legally authorized representative.
Key exclusion criteria
Individuals who do not provide informed consent to participate in the study or who are considered by the investigator to be unable to undergo the study examinations.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Arita |
Organization
Itoh Clinic
Division name
Ophthalmology
Zip code
337-0042
Address
626-11, Minaminakano, Minuma-ku, Saitama City, Saitama, Japan
TEL
09039132360
arita.reiko@gmail.com
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Arita |
Organization
Itoh Clinic
Division name
Ophthalmology
Zip code
337-0042
Address
626-11, Minaminakano, Minuma-ku, Saitama City, Saitama, Japan
TEL
09039132360
Homepage URL
arita.reiko@gmail.com
Sponsor or person
Institute
LIME Working Group
Institute
Department
Personal name
Reiko Arita
Funding Source
Organization
LIME Working Group
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamauchi Clinic
Address
1-15-19, Jiyugaoka, Meguroku, Tokyo, Japan
Tel
0337237717
arita.reiko@gmail.com
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
| 2026 | Year | 10 | Month | 02 | 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
259
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
| 2025 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is the second population-based ophthalmic screening conducted on Taku-shima Island, Hirado City, Nagasaki Prefecture, Japan, following the first screening conducted in 2017. Longitudinal changes in ophthalmic findings will also be evaluated among participants who participated in the previous screening.
Management information
Registered date
| 2026 | Year | 10 | Month | 02 | Day |
Last modified on
| 2026 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072278
