JRCT ID: jRCTs032220268
Registered date:12/08/2022
Exploratory study of intraocular pressure changes in the new self-measuring tonometer "tap eye" in normal and glaucoma patients
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | glaucoma |
Date of first enrollment | 04/12/2022 |
Target sample size | 100 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | The study subjects used the research instruments tap-eye tonometer and the control instruments GAT and NCT. The observation period is one month, and two examinations are carried out baseline and one month later. |
Outcome(s)
Primary Outcome | Correlation coefficient with other tonometer (coefficient of determination: R2) The correlation coefficient when compared with this instrument and the recognized ocular pressure gauge (GAT, NCT) is evaluated. At that time, the evaluation index showed a statistically significant correlation following the previously published paper |
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Secondary Outcome | 1) Coincidence rate of change in intraocular pressure over time 2) Reproducibility in the same study subjects |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | Cases that the principal investigator has determined that the test can be conducted. Prior to entry into this study, consent must be made by signing the explanatory consent form. The following conditions are the eligibility criteria Normal eye and glaucoma eye Glaucoma study subjects do not need to interrupt routine eye drop treatment. Age:18 years old or older Gender:no restrictions |
Exclude criteria | Research subjects who fall under one or more of the following items will be excluded from this study: (a) Less than one month after eye surgery (b) When there is a possibility that an ophthalmologist consultation is required during the clinical research period (c) In addition, when the Principal Investigator judges that the Principal Investigator is inappropriate as the subject of this research |
Related Information
Primary Sponsor | Teshigawara Tsuyoshi |
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Secondary Sponsor | |
Source(s) of Monetary Support | Toneasy, Inc. |
Secondary ID(s) |
Contact
Public contact | |
Name | Akira Kitamura |
Address | 1-2-1 Tsurumi Chuo, Tsurumi-ku, Yokohama-shi, Kanagawa Kanagawa Japan 230-0051 |
Telephone | +81-45-508-1017 |
tsurumi.chuoh.eye.cs@gmail.com | |
Affiliation | Yokohama Tsurumi Chuo Eye Clinic |
Scientific contact | |
Name | Tsuyoshi Teshigawara |
Address | 1-2-1 Tsurumi Chuo, Tsurumi-ku, Yokohama-shi, Kanagawa Kanagawa Japan 230-0051 |
Telephone | +81-45-508-1017 |
teshitake@gmail.com | |
Affiliation | Yokohama Tsurumi Chuo Eye Clinic |