Anterior segment evaluation with a novel anterior segment device

JRCT ID: jRCTs012240004

Registered date:05/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Those who have been diagnosed with anterior eye disease and have inflammation in the anterior chambe
• Date of first enrollment: 05/04/2024
• Target sample size: 100
• Study type: Interventional

Outcome(s)

Primary Outcome

The percentage of agreement between the findings diagnosed (judged) by an ophthalmologist on examination with a conventional instrument such as a slit-lamp microscope and the findings diagnosed by a physician from images taken with this study instrument. The findings shall be as follows.
The percentage of agreement between the calculated values of the cell analysis algorithm of this instrument and the SUN grading (physician's findings) using a slit-lamp microscope.
The percentage of agreement between the SUN grading of flares using this instrument, SUN grading using a slit-lamp microscope, and measurements using a laser flare meter.
Agreement rate between the Emery-Little classification of cataracts using this device and the Emery-Little classification using slit-lamp microscopy.
Agreement rate between corneal curvature measured with this device and corneal curvature measured with anterior segment optical coherence tomography.
Regarding the safety evaluation, the risk of this device is sufficiently low and its safety is well established.

• Secondary Outcome: None

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

The subjects with anterior segment diseases who are attending or being admitted to the Department of Ophthalmology, Hokkaido University Hospital, and who have intra-anterior chamber inflammation, corneal opacity, lens opacity, etc. are eligible for this program.
Patients who meet all of the following criteria are eligible
(1) Men and women who are at least 20 years old and less than 90 years old at the time of consent.
(2) Patients who have been diagnosed with anterior segment diseases such as inflammation in the anterior chamber, corneal opacity, and lens opacity.
(3) Patients who have received a thorough explanation of their participation in this study, and who have given written consent of their own free will based on sufficient understanding.

• Exclude criteria: Other persons deemed inappropriate as research subjects by the principal investigator or subinvestigator.

Related Information

• Primary Sponsor: Tagawa Yoshiaki
• Source(s) of Monetary Support: TOPCON CORPORATION
• Secondary ID(s): Nil known