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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036831
Receipt No. R000041959
Scientific Title Evaluation of safety and efficacy of gonioscope "GS-1"(NIDEK)
Date of disclosure of the study information 2019/05/23
Last modified on 2019/05/23

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Basic information
Public title Evaluation of safety and efficacy of gonioscope "GS-1"(NIDEK)
Acronym Evaluation of safety and efficacy of GS-1
Scientific Title Evaluation of safety and efficacy of gonioscope "GS-1"(NIDEK)
Scientific Title:Acronym Evaluation of safety and efficacy of GS-1
Region
Japan

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

Objectives
Narrative objectives1 Angle will be observed by gonioscope and GS-1 for cases which require gonioscopy. Lens is placed/device is docked on the eye then chamber angle will be photographed from 8 directions, then the time required to take off the lens/device will be measured. Also, NRS score will be written in questionnaire after gonioscopy by gonioscope and GS-1. Concordance rate of gonioscopy by gonioscope and angle photograph by GS-1 will be evaluated. Angle evaluation by anterior OCT will also be compared. Also, outflow reconstruction will be categorized into complete response and resistant, and it will be evaluated to find any characteristics in each angle observation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.Required time for gonioscopy by gonioscope and GS-1
2.Comparison of discomfort and pain caused by gonioscope and GS-1
3.Accuracy of gonioscopy by GS-1 compared to gonioscope
4.Comparison of angle evaluation by GS-1 and anterior OCT
5.Evaluation of distinctive angle observation in outflow reconstruction response and resistant example
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Case which gonioscopy by gonioscope and GS-1 be conducted at Chukyo Eye Clinic
Key exclusion criteria Case without consent from the subject
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Mitsunori
Middle name
Last name Watanabe
Organization Chukyo Eye Clinic
Division name Chukyo Eye Clinic
Zip code 456-0032
Address 12-22 Sanbonmatsu-cho Atsuta-ku, Nagoya, Aichi
TEL 052-883-1543
Email watanabe@chukyogroup.jp

Public contact
Name of contact person
1st name Mitsunori
Middle name
Last name Watanabe
Organization Chukyo Eye Clinic
Division name Chukyo Eye Clinic
Zip code 456-0032
Address 12-22 Sanbonmatsu-cho Atsuta-ku, Nagoya, Aichi
TEL 052-883-1543
Homepage URL
Email watanabe@chukyogroup.jp

Sponsor
Institute Chukyo Eye Clinic
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Chukyo Medical Co., Ltd.
Address 12-23 Sanbonmatsu-cho, Atsuta-ku, Nagoya-city,Aichi
Tel 052-884-7976
Email irb@chukyomedical.co.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
2019 Year 05 Month 23 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 05 Month 23 Day
Date of IRB
2019 Year 05 Month 23 Day
Anticipated trial start date
2019 Year 05 Month 23 Day
Last follow-up date
2022 Year 05 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Angle will be observed by gonioscope and GS-1 for cases which require gonioscopy. Lens is placed/device is docked on the eye then chamber angle will be photographed from 8 directions, then the time required to take off the lens/device will be measured. Also, NRS score will be written in questionnaire after gonioscopy by gonioscope and GS-1. Concordance rate of gonioscopy by gonioscope and angle photograph by GS-1 will be evaluated. Angle evaluation by anterior OCT will also be compared. Also, outflow reconstruction will be categorized into complete response and resistant, and it will be evaluated to find any characteristics in each angle observation.

Management information
Registered date
2019 Year 05 Month 23 Day
Last modified on
2019 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041959

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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