UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039982 |
|---|---|
| Receipt number | R000045588 |
| Scientific Title | Evaluation of intraocular pressure measured by Icare ic200 |
| Date of disclosure of the study information | 2020/04/18 |
| Last modified on | 2020/03/30 16:21:04 |
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Basic information
Public title
Evaluation of intraocular pressure measured by Icare ic200
Acronym
Evaluation of intraocular pressure measured by Icare ic200
Scientific Title
Evaluation of intraocular pressure measured by Icare ic200
Scientific Title:Acronym
Evaluation of intraocular pressure measured by Icare ic200
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1)Evaluation of intraocular pressure(IOP) measured by Icare ic200.
2) Comparison of IOP with Goldmann tonometer and IcarePRO.
3) Estimations of IOP rise induced by posture change in patients with glaucoma.
Basic objectives2
Others
Basic objectives -Others
Posture induced IOP and its'relation with filtering surgery.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Agreement and reproducibility among tonometers.
2) Posture induced IOP.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with glaucoma.
Key exclusion criteria
Patients who are unacceptable with Goldmann applanation tonometer or rebound tonometer.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Nakakura |
| Middle name | |
| Last name | Shunsuke |
Organization
Saneikai Tsukazaki Hospital
Division name
Department of Ophthalmology
Zip code
6711227
Address
Aboshi waku 68-1
TEL
079-272-8555
shunsukenakakura@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Nakakura |
| Middle name | |
| Last name | Shunsuke |
Organization
Saneikai Tsukazaki Hospital
Division name
Ophtahlmology
Zip code
6711227
Address
Aboshi waku 68-1
TEL
079-272-8555
Homepage URL
shunsukenakakura@yahoo.co.jp
Sponsor or person
Institute
Saneikai Tsukazaki Hospital
Institute
Department
Personal name
Funding Source
Organization
Saneikai Tsukazaki Hospital
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
Saneikai Tsukazaki Hospital
Address
Aboshi waku 68-1
Tel
079-272-8555
m.kosenbo@tsukazkai-eye.net
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 | 04 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2020 | Year | 03 | Month | 30 | Day |
Last modified on
| 2020 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045588
