UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038367 |
|---|---|
| Receipt number | R000043655 |
| Scientific Title | An effect of past vitrectomy on intraocular pressure after intravitreal triamcinolone acetonide for diabetic macular edema. |
| Date of disclosure of the study information | 2019/10/23 |
| Last modified on | 2019/10/23 15:17:41 |
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Basic information
Public title
An effect of past vitrectomy on intraocular pressure after intravitreal triamcinolone acetonide for diabetic macular edema.
Acronym
An effect of past vitrectomy on intraocular pressure after intravitreal triamcinolone acetonide for diabetic macular edema.
Scientific Title
An effect of past vitrectomy on intraocular pressure after intravitreal triamcinolone acetonide for diabetic macular edema.
Scientific Title:Acronym
An effect of past vitrectomy on intraocular pressure after intravitreal triamcinolone acetonide for diabetic macular edema.
Region
| Japan |
Condition
Condition
diabetic macular edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the intraocular pressure after intravitreal triamcinolone acetonide is lower in vitrectomized eyes than non-vitrectomized eyes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intra ocular pressure at preoperative, 1 week, 4 weeks, 12 weeks, and 24 weeks after the treatment
Key secondary outcomes
best corrective visual acuity and foveal thickness at preoperative, 1 week, 4 weeks, 12 weeks, and 24 weeks after the treatment.
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
patients who were treated with intravitreal triamcinolone acetonide from April 1st, 2012 to October 31st, 2018.
Key exclusion criteria
patients who rejected a registration to this study
patients who were assessed not suitable by principal or sub investigator
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Takamura |
| Middle name | |
| Last name | Yoshihiro |
Organization
Faculty of medical sciences, University of Fukui
Division name
Department of Ophthalmology
Zip code
910-1193
Address
23-3 Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
TEL
0776-61-8400
ytakamura@hotmail.com
Public contact
Name of contact person
| 1st name | Orii |
| Middle name | |
| Last name | Yusuke |
Organization
Faculty of medical sciences, University of Fukui
Division name
Department of Ophthalmology
Zip code
910-1193
Address
23-3 Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
TEL
0776-61-8400
Homepage URL
orii@g.u-fukui.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Faculty of medical sciences, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
no
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
Faculty of medical sciences, University of Fukui
Address
Department of Ophthalmology, Faculty of medical sciences, University of Fukui
Tel
0776-61-8400
rinrisys@ml.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
| 2019 | Year | 10 | Month | 23 | 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
150
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
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective study.
Management information
Registered date
| 2019 | Year | 10 | Month | 23 | Day |
Last modified on
| 2019 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043655
