UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008320 |
|---|---|
| Receipt number | R000009796 |
| Scientific Title | Comparison of intraocular pressure measurements on the bed by four portable tonometer including icare pro. |
| Date of disclosure of the study information | 2012/07/15 |
| Last modified on | 2013/02/25 11:05:56 |
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Basic information
Public title
Comparison of intraocular pressure measurements on the bed by four portable tonometer including icare pro.
Acronym
Comparison of intraocular pressure on the supine position.
Scientific Title
Comparison of intraocular pressure measurements on the bed by four portable tonometer including icare pro.
Scientific Title:Acronym
Comparison of intraocular pressure on the supine position.
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate intraocular pressure on the bed among four portable tonometers and thier agreements
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraocular pressure
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Healty volunteers
2 Subjects who sign an informed consent form
Key exclusion criteria
1 Subjects with any ocular diseases.
2 Subjects with previous any ocular surgery.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Nakakura |
Organization
Saneikai Tsukazaki Hospital
Division name
Ophthalmolgy
Zip code
Address
Himeji City Aboshi Waku 68-1
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Nakakura |
Organization
Saneikai Tsukazaki Hospital
Division name
Ophthalmolgy
Zip code
Address
Himeji City Aboshi Waku 68-1
TEL
+81-79-272-8555
Homepage URL
shunsukenakakura@yahoo.co.jp
Sponsor or person
Institute
Saneikai Tsukazaki Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2012 | Year | 07 | 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
The repeatability of Icare PRO was slightly lower in the supine position than in the sitting position. Although Icare PRO underestimated IOP values in eyes with higher IOP when compared with Tonopen XL and Kowa HAT in both positions, we observed good inter-device agreement between Icare PRO and both Tonopen XL and Kowa HAT.
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
| 2012 | Year | 07 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 01 | Month | 31 | Day |
Other
Other related information
To evaluate intraocular pressure by icare pro, TonopenXL, Diaton tonometer and handled applanation tonometer
Management information
Registered date
| 2012 | Year | 07 | Month | 02 | Day |
Last modified on
| 2013 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009796
