NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedglaucoma
Date of first enrollment04/12/2022
Target sample size100
Countries of recruitment
Study typeInterventional
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 OutcomeCorrelation 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
Secondary Outcome1) Coincidence rate of change in intraocular pressure over time 2) Reproducibility in the same study subjects

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteriaCases 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 criteriaResearch 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

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
E-mail 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
E-mail teshitake@gmail.com
Affiliation Yokohama Tsurumi Chuo Eye Clinic