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Clinical study for regulatory approval of new medical device "Image diagnosis support program for eye observation"

Clinical study for regulatory approval of new medical device "Image diagnosis support program for eye observation" - Clinical study for regulatory approval of new medical device "Image diagnosis support program for eye observation"

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000053497
Enrollment
200
Registered
2024-02-29
Start date
2024-03-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Interventions

None listed

Sponsors

Department of Ophthalmology, Keio University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Among the cases of "Approval number: 20200283 Ophthalmological image analysis using artificial intelligence", cases with nuclear sclerosis cataract (including cases with other ophthalmological diseases) among those who have consented to permission for secondary use. Among the above cases, cases in which anterior segment images were taken using a slit lamp microscope as part of routine medical treatment.

Exclusion criteria

Exclusion criteria: Cases that refused to participate in the study Cases used in the development of the verification algorithm (research by the Minami Aoyama Eye Clinic Ethics Review Committee (202101)) (learning dataset for the algorithm scheduled to be verified in this research) Other cases judged to be inappropriate by the primary investigator or sub-investigator

Design outcomes

Primary

MeasureTime frame
"Sensitivity", "specificity", and "AUC" of the diagnosis results of this program when the diagnosis by an ophthalmologist is considered as the correct answer in the evaluation dataset. In the evaluation data set, when the ophthalmologist's diagnosis is considered the correct answer, whether or not the ophthalmologist's diagnosis result and the diagnosis result of this program are non-inferior.

Countries

Japan

Contacts

Public ContactMasatoshi Hirayama

Keio University schooKeio University school of medicine Department of Ophthalmology

mar_hirayama@keio.jp03-5363-3821

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026