UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055641 |
|---|---|
| Receipt number | R000063587 |
| Scientific Title | Multicenter study on the efficacy of vitreous surgery for diabetic macular edema and vitreomacular traction in Japan |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2024/09/26 20:55:02 |
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Basic information
Public title
Multicenter study on the efficacy of vitreous surgery for diabetic macular edema and vitreomacular traction in Japan
Acronym
Multicenter study on the efficacy of vitreous surgery for DME and VMT in Japan
Scientific Title
Multicenter study on the efficacy of vitreous surgery for diabetic macular edema and vitreomacular traction in Japan
Scientific Title:Acronym
Multicenter study on the efficacy of vitreous surgery for DME and VMT in Japan
Region
| Japan |
Condition
Condition
Diabetic macular edema and vitreomacular traction
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of vitreous surgery for diabetic macular edema and vitreomacular traction in Japan at multiple institutions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Corrected visual acuity one year after vitreous surgery
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
1. Patients who underwent vitreous surgery for DME and vitreomacular traction at each research institution between January 2010 and the date of ethical committee approval
2. Patients who were able to be followed up for more than 6 months after surgery
3. Patients who were able to undergo three-dimensional fundus image analysis OCT before and after surgery
4. Age: Any
5. Gender: Any
6. There are no restrictions on other treatments for DME, such as anti-VEGF drugs or laser treatment
Key exclusion criteria
1. Patients who declined to participate in this study
2. Patients with retinal diseases other than DME
3. Patients who are missing all information on OCT
4. Cases with tractional retinal detachment due to proliferative membrane
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Yamada |
Organization
university of Fukui hospital
Division name
Ophthalomology
Zip code
9101193
Address
23-3 Shimoaizuki, Matsuoka, Eiheiji-cho, Yoshida-gun, Fukui Prefecture
TEL
0776613111
yyutaka@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Yamada |
Organization
university of Fukui hospital
Division name
Ophthalmology
Zip code
9101193
Address
23-3 Shimoaizuki, Matsuoka, Eiheiji-cho, Yoshida-gun, Fukui Prefecture
TEL
0776613111
Homepage URL
yyutaka@u-fukui.ac.jp
Sponsor or person
Institute
university of Fukui
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
The Research Ethics Committee of University of Fukui
Address
23-3 Shimoaizuki, Matsuoka, Eiheiji-cho, Yoshida-gun, Fukui Prefecture
Tel
0776613111
yyutaka@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
| 2024 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will retrospectively observe cases of diabetic macular edema and associated vitreous-macular traction who underwent vitreous surgery.
Data will be collected from collaborating facilities in Japan.
The efficacy will be verified based on progress up to one year after surgery.
Management information
Registered date
| 2024 | Year | 09 | Month | 26 | Day |
Last modified on
| 2024 | 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=R000063587
