UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057173 |
|---|---|
| Receipt number | R000065358 |
| Scientific Title | Survey of macular pigment and skin carotenoid optical density in patients with age-related macular degeneration |
| Date of disclosure of the study information | 2025/02/28 |
| Last modified on | 2026/03/03 09:32:55 |
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Basic information
Public title
Survey of macular pigment and skin carotenoid optical density in patients with age-related macular degeneration
Acronym
Macular pigment in patients with age-related macular degeneration
Scientific Title
Survey of macular pigment and skin carotenoid optical density in patients with age-related macular degeneration
Scientific Title:Acronym
Macular pigment in patients with age-related macular degeneration
Region
| Japan |
Condition
Condition
age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We previously reported using resonance Raman spectroscopy that patients with age-related macular degeneration (AMD) have lower macular pigment levels than healthy individuals. In this study, we measured macular pigment density in AMD patients and healthy individuals using fundus autofluorescence spectroscopy to validate our previous findings.
Basic objectives2
Others
Basic objectives -Others
To compare the skin carotenoid levels between patients with age-related macular degeneration and healthy individuals.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Macular pigment optical density
Key secondary outcomes
Skin carotenoid level
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
Patients diagnosed with age-related macular degeneration (AMD) in one eye and the fellow eye unaffected by AMD (either with a normal fundus or in the early stages of AMD), as well as patients without macular diseases, where the eye under examination (either the AMD-unaffected eye or the normal fundus eye) has undergone cataract surgery or has only minimal cataract.
Key exclusion criteria
1) Individuals receiving dietary counseling due to chronic illnesses
2) Individuals with macular diseases other than age-related macular degeneration
3) Individuals with opacities in the cornea or other ocular media
Target sample size
234
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Obana |
Organization
Seirei Hamamamstu General Hospital
Division name
Eye center
Zip code
4308558
Address
2-12-12 Sumiyoshi, Chuo-ku, Hamamatsu City, Shizuoka Prefecture
TEL
053-474-2222
obana@sis.seirei.or.jp
Public contact
Name of contact person
| 1st name | Mituo |
| Middle name | |
| Last name | Kimata |
Organization
Seirei Hamamatsu General Hospital
Division name
Clinical research center
Zip code
4308558
Address
2-12-12 Sumiyoshi, Chuo-ku, Hamamatsu City, Shizuoka Prefecture
TEL
053-474-2222
Homepage URL
m-kimata@sis.seirei.or.jp
Sponsor or person
Institute
Seirei Social Wellfare Community, Seirei Hamamatsu General Hospital
Institute
Department
Personal name
Funding Source
Organization
Seirei Social Wellfare Community, Seirei Hamamatsu General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center, Seirei Hamamatsu General Hospital
Address
2-12-12 Sumiyoshi, Chuo-ku, Hamamatsu City, Shizuoka Prefecture
Tel
0534742222
m-kimata@sis.seirei.or.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
聖隷浜松病院アイセンター
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 28 | 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 | 11 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | 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 involves a cross-sectional observation of the patients, with measurements conducted only once at a single point in time.
Management information
Registered date
| 2025 | Year | 02 | Month | 28 | Day |
Last modified on
| 2026 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065358
