UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052310 |
|---|---|
| Receipt number | R000059209 |
| Scientific Title | Longitudinal analyses of ocular findings and background factors |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2023/09/26 06:13:47 |
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Basic information
Public title
Longitudinal analyses of ocular findings and background factors
Acronym
Longitudinal analyses of ocular findings and background factors
Scientific Title
Longitudinal analyses of ocular findings and background factors
Scientific Title:Acronym
LOBACK
Region
| Japan |
Condition
Condition
Ocular diseases and aging
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Medical technologies in the field of ocular diagnosis, surgery, and medical treatment have progressed, remarkably. The study will be informative for the future development of new diagnostic and therapeutic approaches.
Basic objectives2
Others
Basic objectives -Others
Analyses for ocular findings and the treatment outcomes will be of value to reveal pathogenesis and mechanisms of aging and frailty. We retrospectively analyze the results of eye examinations for visual function and refraction, intraocular pressure, corneal endothelial cells, fundus photographs including autofluorescence and angiography, optical coherence tomography, axial length and ocular structure, visual field, retinal sensitivity, and electrophysiology, and interview, blood pressure measurement, as well as all the systemic data obtained in our institute.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between ocular findings and background factors
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those whose ocular data were obtained in our institute after October 1, 2023.
Key exclusion criteria
Those who denyed to join, and who were judged as inappropriate for the study by the researchers.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Ozawa |
Organization
Fujita Medical Innovation Center Tokyo
Fujita Health University School of Medicine
Division name
Department of Clinical Regenerative Medicine, Eye Center
Zip code
104-8560
Address
1-1-4 HICity zone A, Haneda-kuko, Otaku, Tokyo
TEL
+81335415151
ozaway@luke.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Ozawa |
Organization
Fujita Medical Innovation Center Tokyo, Fujita Health University School of Medicine
Division name
Department of Clinical Regenerative Medicine, Eye Center
Zip code
144-0041
Address
1-1-4 HICity zone A, Haneda-kuko, Otaku, Tokyo
TEL
+81357087830
Homepage URL
yoko.ozawa@fujita-hu.ac.jp
Sponsor or person
Institute
Department of Clinical Regenerative Medicine
Eye Center, Fujita Medical Innovation Center Tokyo
Fujita Health University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University School of Medicine
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
Fujita Medical Innovation Center Tokyo, Fujita Health University School of Medicine
Address
1-1-4 HICity zone A, Haneda-kuko, Otaku, Tokyo
Tel
+8157087830
yoko.ozawa@fujita-hu.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 01 | 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
| 2023 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study is on-going.
Management information
Registered date
| 2023 | Year | 09 | Month | 26 | Day |
Last modified on
| 2023 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059209
