UMIN-CTR Clinical Trial

Basic information
Public title	Outcome of surgery with glaucoma drainage devices
Acronym	Outcome of surgery with glaucoma drainage devices
Scientific Title	Outcome of surgery with glaucoma drainage devices
Scientific Title:Acronym	Outcome of surgery with glaucoma drainage devices
Region	Japan

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

Objectives
Narrative objectives1	To assess surgical outcome with glaucoma drainage devices
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	IOP, complications
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Glaucoma surgery with GDDs
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	refractory glaucoma with eye drops
Key exclusion criteria	Reduced corneal endothelial cells
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Masayuki Middle name Last name Akimoto
Organization	Osaka Red Cross Hospital
Division name	Ophthalmology
Zip code	543-8555
Address	5-30 Fudegasakicho, Tennojiku
TEL	0667745111
Email	masayuki@akimoto3.com

Public contact
Name of contact person	1st name Masayuki Middle name Last name Akimoto
Organization	Osaka Red Cross Hospital
Division name	Ophthalmology
Zip code	543-8555
Address	5-30 Fudegasakicho, Tennojiku
TEL	0667745111
Homepage URL
Email	masayuki@akimoto3.com

Sponsor
Institute	Osaka Red Cross Hospital
Institute
Department

Funding Source
Organization	none
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	Osaka Red Cross Hospital
Address	5-30 Fudegasakicho, Tennnojiku, Osaka
Tel	0667745111
Email	soumudaiichi@osaka-med.jrc.or.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	2021 Year 01 Month 12 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	20
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	2016 Year 01 Month 01 Day
Date of IRB	2016 Year 01 Month 01 Day
Anticipated trial start date	2018 Year 10 Month 08 Day
Last follow-up date	2020 Year 05 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 01 Month 12 Day
Last modified on	2021 Year 01 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048627

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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