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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032749
Receipt No. R000037155
Scientific Title Prospective observational study to improve the prognosis of glaucoma filtering surgery
Date of disclosure of the study information 2018/05/28
Last modified on 2019/05/29

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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

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 05 Month 29 Day


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

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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