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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025216
Receipt No. R000029005
Scientific Title Effects of suture trabeculotomy ab interno on posture-induced intraocular pressure changes for open angle glaucoma
Date of disclosure of the study information 2016/12/15
Last modified on 2018/06/12

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Basic information
Public title Effects of suture trabeculotomy ab interno on posture-induced intraocular pressure changes for open angle glaucoma
Acronym Effects of suture trabeculotomy ab interno on posture-induced intraocular pressure changes
Scientific Title Effects of suture trabeculotomy ab interno on posture-induced intraocular pressure changes for open angle glaucoma
Scientific Title:Acronym Effects of suture trabeculotomy ab interno on posture-induced intraocular pressure changes
Region
Japan

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

Objectives
Narrative objectives1 To determine whether suture trabeculotomy ab interno affects postural-induced changes in intraocular pressure.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes postural-induced changes in intraocular pressure during 3-month after surgery
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 suture trabeculotomy ab interno
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 with glaucoma to treat by suture trabeculotomy ab interno.
Key exclusion criteria None
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoki Sato
Organization Sato Eye and Internal Medicine Clinic
Division name Department of ophthalmology
Zip code
Address 4160-270 Arao, Arao City, Kumamoto
TEL 0968-65-5900
Email kawag@white.plala.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Kawaji
Organization Sato Eye and Internal Medicine Clinic
Division name Department of ophthalmology
Zip code
Address 4160-270 Arao, Arao City, Kumamoto
TEL 0968-65-5900
Homepage URL
Email kawag@white.plala.or.jp

Sponsor
Institute Sato Eye and Internal Medicine Clinic
Institute
Department

Funding Source
Organization Self funding
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
Address
Tel
Email

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 12 Month 15 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 Completed
Date of protocol fixation
2016 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 01 Day
Last follow-up date
2017 Year 08 Month 01 Day
Date of closure to data entry
2017 Year 08 Month 01 Day
Date trial data considered complete
2017 Year 08 Month 01 Day
Date analysis concluded
2017 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2016 Year 12 Month 10 Day
Last modified on
2018 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029005

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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