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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041290
Receipt No. R000047038
Scientific Title The comparison of incisions for trabecular meshwork in minimally invasive glaucoma surgery
Date of disclosure of the study information 2020/08/03
Last modified on 2020/08/03

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Basic information
Public title The comparison of incisions for trabecular meshwork in minimally invasive glaucoma surgery
Acronym The comparison of incisions for trabecular meshwork in minimally invasive glaucoma surgery
Scientific Title The comparison of incisions for trabecular meshwork in minimally invasive glaucoma surgery
Scientific Title:Acronym The comparison of incisions for trabecular meshwork in minimally invasive glaucoma surgery
Region
Japan

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

Objectives
Narrative objectives1 To investigate the incision for trabecular meshwork after trabeculotomy using Kahook dual brade or trabeculotomy micro hook
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cross-sectional area of incision for trabecular meshwork
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Ab interno trabeculotomy with Kahook dual brade
Interventions/Control_2 Ab interno trabeculotomy with micro hook
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. The patients with primary open angle glaucome or exfoliation glaucoma
2. The patients with cataract
Key exclusion criteria 1. History of glaucoma surgery (including laser treatment)
2. History of vitreous surgery
3. History of cataract surgery
4. Those who are pregnant, breastfeeding, who may be pregnant, and who wish to become pregnant during the study period
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Shogo
Middle name
Last name Arimura
Organization Faculty of medical science, university of Fukui
Division name Ophthalmology
Zip code 910-1193
Address 23-3 Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
TEL 0776-61-3111
Email leo33@u-fukui.ac.jp

Public contact
Name of contact person
1st name Shogo
Middle name
Last name Arimura
Organization Faculty of medical science, university of Fukui
Division name Ophthalmology
Zip code 910-1193
Address 23-3 Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
TEL 0776-61-8400
Homepage URL
Email leo33@u-fukui.ac.jp

Sponsor
Institute University of Fukui
Institute
Department

Funding Source
Organization Not applicable
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 Faculty of medical science, university of Fukui
Address 23-3 Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
Tel 0776-61-3111
Email rinsho-rinri@ml.u-fukui.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
2020 Year 08 Month 03 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
2019 Year 07 Month 08 Day
Date of IRB
2019 Year 07 Month 16 Day
Anticipated trial start date
2019 Year 07 Month 16 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 08 Month 03 Day
Last modified on
2020 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047038

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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