UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051108 |
|---|---|
| Receipt number | R000058178 |
| Scientific Title | A multi-institutional survey of diabetic patients who certified visually impaired in Japan |
| Date of disclosure of the study information | 2023/05/19 |
| Last modified on | 2025/11/20 14:41:58 |
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Basic information
Public title
A multi-institutional survey of diabetic patients who certified visually impaired in Japan
Acronym
A multi-institutional survey of diabetic patients who certified visually impaired in Japan
Scientific Title
A multi-institutional survey of diabetic patients who certified visually impaired in Japan
Scientific Title:Acronym
A multi-institutional survey of diabetic patients who certified visually impaired in Japan
Region
| Japan |
Condition
Condition
diabetes,diabetic retinopathy,visual impairment
Classification by specialty
| Medicine in general | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the Background of Patients with Diabetic Retinopathy who Obtained a Visually Impaired Certificate
Basic objectives2
Others
Basic objectives -Others
Investigating diabetic retinopathy conditions leading to visual impairment
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
visual acuity, visual field at first visit and the time acquiring a visually impaired certificate
fundus findings at frist visit,
blood test results
history of hospital visits, history of treatment
fundus disease leading to visual impairment
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Diabetes outpatients who have acquired a visually impaired certificate
2 A record of examination and fundus findings at the first visit can be confirmed on the chart
Key exclusion criteria
nothing particularly
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | YUKA |
| Middle name | |
| Last name | SUGIHARA |
Organization
university of Fukui Hospital
Division name
Ophthalmology
Zip code
910-1104
Address
23-3 Shimoaitsuki Matsuoka, Eiheiji Town, Yoshida District, Fukui Prefecture
TEL
0776-61-3111
ysghr@g.u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | YUKA |
| Middle name | |
| Last name | SUGIHARA |
Organization
Fukui University Hospital
Division name
Ophthalmology
Zip code
910-1104
Address
23-3 Shimoaitsuki Matsuoka, Eiheiji Town, Yoshida District, Fukui Prefecture
TEL
0776618403
Homepage URL
ysghr@g.u-fukui.ac.jp
Sponsor or person
Institute
university of Fukui
Institute
Department
Personal name
Funding Source
Organization
university of Fukui
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
university of Fukui Hospital
Address
23-3 Shimoaitsuki Matsuoka, Eiheiji Town, Yoshida District, Fukui Prefecture
Tel
0776618403
ysghr@g.u-fukui.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 | 05 | Month | 19 | Day |
Related information
URL releasing protocol
https://www.ndmc.ac.jp/wp-content/uploads/2023/08/4826.pdf
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/38534040/
Number of participants that the trial has enrolled
408
Results
In Japan, blind patients with diabetes mellitus are characterized by severe conditions such as neovascular glaucoma and progressive proliferative diabetic retinopathy upon their initial visit to an advanced care facility. These results highlight the importance of monitoring retinopathy through regular ophthalmological examinations, internal medicine, and appropriate therapeutic intervention.
Results date posted
| 2025 | Year | 11 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 03 | Month | 27 | Day |
Baseline Characteristics
Patients who have attended advanced medical institutions for diabetic retinopathy and have obtained a visually impaired person's certificate
Participant flow
Extract patients who have obtained a visually impaired person's certificate due to diabetic retinopathy from their medical records.
Adverse events
None
Outcome measures
age, sex, DM type, glycated hemoglobin (HbA1c) level, visual acuity, IOP, DR grade, central retinal thickness (CRT), number of injections of anti-VEGF agents, vitrectomy, and surgery for NVG
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
nothing particular
Management information
Registered date
| 2023 | Year | 05 | Month | 19 | Day |
Last modified on
| 2025 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058178
