UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective Study on Postoperative Results of Glaucoma Filtration Surgery with Mitomycin C
Title of the study (Brief title)	Prospective Study on Glaucoma Filtration Surgery with Mitomycin C
Region	Japan

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

Objectives
Narrative objectives1	To prospectively investigate the satefy, efficacy, and influencing factors for postoperative results of glaucoma fliltration surgery with Mitomycin C
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	intraocular pressure the frequency and the content of adverse events
Key secondary outcomes	visual acuity visual field optical coherence tomography corneal endothelial cells

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Glaucoma filtration surgery with Mitomycin C
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 require glaucoma filtration surgery Subjects who sign an informed consent form to participate in the clinical study
Key exclusion criteria	Subjects who a doctor in attendance declares ineligible for any reason
Target sample size	200

Research contact person
Name of lead principal investigator	Akitaka Tsujikawa
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Ophthalmology and Visual Sciences
Address	54 Shougoin Kawahara-cho, Sakyo-ku, Kyoto
TEL	075-751-3248
Email	eye@med.kyoto-u.ac.jp

Public contact
Name of contact person	Takanori Kameda
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Ophthalmology and Visual Sciences
Address	54 Shougoin Kawahara-cho, Sakyo-ku, Kyoto
TEL	075-751-3727
Homepage URL
Email	eye@med.kyoto-u.ac.jp

Sponsor
Institute	Department of Ophthalmology & Visual Sciences, Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Management Expenses Grants
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 03 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 02 Month 01 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 16 Day
Last modified on	2018 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024039