UMIN-CTR Clinical Trial

Basic information
Public title	Prospective observational study to improve the prognosis of glaucoma filtering surgery
Acronym	Observational study for the filterig blebs
Scientific Title	Prospective observational study to improve the prognosis of glaucoma filtering surgery
Scientific Title:Acronym	Observational study for the filterig blebs
Region	Japan

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

Objectives
Narrative objectives1	To investigate the prognosis after glaucoma filtering surgery prospectively
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of Birefringence of filtering blebs beteween success and failure after glaucoma filtering surgery
Key secondary outcomes

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	(1) Surgical patients who will undergo glaucoma filtering surgery (2) Patients who understood and signed letter of consent (3) Patients without ocular surface surgery affecting the flitering blebs,
Key exclusion criteria	(1) Patients who aren't able to visit the medical institution at pre-defined visits as instructed by the physician (2) Patients assessed as inappropriate to be enrolled in this observational study by the physician
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Satoru Middle name Last name Tsuda
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Ophthalmology
Zip code	980-8574
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL	81-22-717-7294
Email	tsuda@oph.med.tohoku.ac.jp

Public contact
Name of contact person	1st name Taiki Middle name Last name Kokubun
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Ophthalmology
Zip code	980-8574
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL	81-22-717-7294
Homepage URL
Email	t-kokubun@oph.med.tohoku.ac.jp

Sponsor
Institute	Department of Ophthalmology, Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	MHLW CertifieClinical Research Review Board, Tohoku University
Address	2-1-1 Katahira, Aoba-ku, Sendai, Miyagi, 980-8577 Japan
Tel	022-718-0461
Email	office@nrs.hosp.tohoku.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	東北大学病院（宮城県）

Other administrative information
Date of disclosure of the study information	2018 Year 05 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
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	Open public recruiting
Date of protocol fixation	2018 Year 03 Month 30 Day
Date of IRB	2018 Year 03 Month 30 Day
Anticipated trial start date	2018 Year 06 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This is a study to examine the differences between success and failure after glaucoma filtering surgery and to investigate the the factors to predict the prognosis after the surgery. We follow up the patients undergoing filtering surgery prospectively for 12 months after the surgery.

Management information
Registered date	2018 Year 05 Month 28 Day
Last modified on	2019 Year 12 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037155