UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036831 |
|---|---|
| Receipt number | 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 | 2023/04/25 15:57:45 |
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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
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
watanabe@chukyogroup.jp
Sponsor or person
Institute
Chukyo Eye Clinic
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0284098
Number of participants that the trial has enrolled
70
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
| 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
| 2023 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041959
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
