Clinical Study on the Safety and Usefulness of a Smartphone-Connected Fundus Camera

JRCT ID: jRCTs062240102

Registered date:07/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: none
• Date of first enrollment: 07/01/2025
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Fundus imaging with smartphone-connected fundus camera

Outcome(s)

• Primary Outcome: Fundus Image Acquisition Rate
• Secondary Outcome: In facilities with existing fundus cameras, the agreement rate in ophthalmologist readings of fundus images taken with smartphone-connected fundus cameras and existing fundus cameras.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. patients who are at least 18 years of age (regardless of gender) at the time consent is obtained
2. patients whose consent to participate in this study is obtained in writing
3. patients who are deemed by the physician to have ocular fundus diseases that are desirable to be examined

Exclude criteria

1. patients who have been judged by the principal investigator or a subinvestigator of the study to be unjustly disadvantaged by participation in the study
2. Patients whose participation in the study has been judged by the principal investigator or a subinvestigator to cause difficulty in the conduct or evaluation of this clinical study.

Related Information

• Primary Sponsor: Kazuyuki Hirooka
• Secondary Sponsor: Mizuno Yu
• Source(s) of Monetary Support: AMED