UMIN-CTR Clinical Trial

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
Email	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
Email	orii@g.u-fukui.ac.jp

Sponsor
Institute	Department of Ophthalmology, Faculty of medical sciences, University of Fukui
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043655