UMIN-CTR Clinical Trial

Basic information
Public title	Postoperative complications of tube shunt surgery
Acronym	Tube shunt complications
Scientific Title	Postoperative complications of tube shunt surgery
Scientific Title:Acronym	Tube shunt complications
Region	Japan

Condition
Condition	Glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the complications of tube shunt surgery
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Corneal endothelial cell number
Key secondary outcomes	Tube position

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients with previous trabeculectomy The patients with extensive surgical scar
Key exclusion criteria	The patients with previous tube shunt surgery
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Masaru Middle name Last name Inatani
Organization	University of Fukui
Division name	Department of Ophthalmology
Zip code	9101193
Address	23-3 Shimoaizuki Matsuoka Eiheiji Yoshida Fukui
TEL	0776-61-8403
Email	inatani@u-fukui.ac.jp

Public contact
Name of contact person	1st name Masaru Middle name Last name Inatani
Organization	University of Fukui
Division name	Department of Ophthalmology
Zip code	9101193
Address	23-3 Shimoaizuki Matsuoka Eiheiji Yoshida Fukui
TEL	0776-61-8403
Homepage URL
Email	inatani@u-fukui.ac.jp

Sponsor
Institute	University of Fukui
Institute
Department

Funding Source
Organization	University of Fukui
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	IRB
Address	23-3 Shimoaizuki Matsuoka Eiheiji Yoshida Fukui
Tel	0776-61-8401
Email	fganka@med.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	2012 Year 04 Month 24 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	100
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	2012 Year 04 Month 23 Day
Date of IRB	2012 Year 04 Month 01 Day
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The observation of postoperative corneal endothelial cells and tube position.

Management information
Registered date	2012 Year 04 Month 23 Day
Last modified on	2021 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009200