UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026906 |
|---|---|
| Receipt number | R000030868 |
| Scientific Title | Foveal Microstructure Analysis in Eyes with Diabetic Macular Edema Treated with Vitrectomy |
| Date of disclosure of the study information | 2017/04/10 |
| Last modified on | 2017/04/08 16:03:07 |
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Basic information
Public title
Foveal Microstructure Analysis in Eyes with Diabetic Macular Edema Treated with Vitrectomy
Acronym
Foveal Microstructure Analysis in Eyes with DME Treated with Vitrectomy
Scientific Title
Foveal Microstructure Analysis in Eyes with Diabetic Macular Edema Treated with Vitrectomy
Scientific Title:Acronym
Foveal Microstructure Analysis in Eyes with DME Treated with Vitrectomy
Region
| Japan |
Condition
Condition
Diabetic macular edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the surgical outcome, and factors affecting outcomes after vitrectomy for diabetic macular edema.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of visual acuity
Key secondary outcomes
Improvement of retinal thickness
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
One year outcome after vitrectomy
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
Patients are include having DM and diabetic macular edema.
Key exclusion criteria
Patients are excluded if they had a history of prior scleral buckling and pars plana vitrectomy, and high myopia with a refractive error of greater than -8.0 diopters, severe cataract of higher than grade 3, glaucoma, or type 1 diabetes mellitus, and if macular laser grid and/or panretinal photocoagulation (PRP) and subtenon TA (STTA) had been performed within 3 months before study enrollment.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jiro Kogo |
Organization
St. Marianna University School of Medicine
Division name
Ophthalmology
Zip code
Address
2-16-1 Sugao Miyamae-ku Kawasaki, Kanagawa
TEL
044-977-8111
kogo@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jiro Kogo |
Organization
St. Marianna University School of Medicine
Division name
Ophthalmology
Zip code
Address
2-16-1 Sugao Miyamae-ku Kawasaki, Kanagawa
TEL
044-977-8111
Homepage URL
kogo@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Department of Ophthalmology
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
Address
Tel
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
| 2017 | Year | 04 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 04 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 02 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 08 | Day |
Last modified on
| 2017 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030868
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
