UMIN-CTR Clinical Trial

Basic information
Public title	Baerveldt glaucoma implant with two tubes inserted into the vitreous cavity
Acronym	Baerveldt glaucoma implant with two tubes inserted into the vitreous cavity
Scientific Title	Baerveldt glaucoma implant with two tubes inserted into the vitreous cavity
Scientific Title:Acronym	Baerveldt glaucoma implant with two tubes inserted into the vitreous cavity
Region	Japan

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

Objectives
Narrative objectives1	To investigate a new surgical technique designed to increase filtration volume with two parallel tubes and one plate of Baerveldt glaucoma implant
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	Intraocular pressure, Supplementa medical therapy score
Key secondary outcomes	Corneal endothelial cell count, intraoperative and early postoperative complications

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	Maneuver
Interventions/Control_1	Double tube insertion
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Neovascular glaucoma cases
Key exclusion criteria	Previous tube shunt surgery
Target sample size	10

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	Osaka Red Cross Hospital
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	Self funding
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, Tennojiku, Osaka
Tel	0667745111
Email	masayuki@akimoto3.com

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	2022 Year 03 Month 28 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	10
Results	Preoperative IOP Double: 32.0+-11.33 (4.1), Single: 29.7+-6.31 (5.7) At 12 months Double: 11.8+-2.70 (0.2), Single: 14.2+-4.05 (1.1)
Results date posted	2022 Year 03 Month 28 Day
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 04 Month 14 Day
Date of IRB	2019 Year 04 Month 28 Day
Anticipated trial start date	2019 Year 05 Month 01 Day
Last follow-up date	2022 Year 03 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 03 Month 28 Day
Last modified on	2022 Year 03 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053941