Home OCT study

Exploratory trial to assess the feasibility of retinal monitoring at home using a home-OCT device

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs032240086

Enrollment

Registered

2024-05-15

Start date

2024-10-16

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Diabetic Macular Edema Diabetic Macular Edema

Interventions

The trial consists of Parts 1 and 2. In Part 1, healthy subjects (medical professionals of the study site, Shinshu University Hospital) and patients with retinal diseases are enrolled. In Part 2, DME

however, examinations beyond this period are also permitted, specifically during the interval between scheduled visits at four-week intervals in the preceding clinical study, during which stationary

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects satisfying all of the inclusion criteria listed below are eligible for the trial. Inclusion criteria for Part 1 and 2 Subjects who received sufficient explanation on the details of the trial and submitted written consent voluntarily. Subjects 18 years of age or older at informed consent. Inclusion criteria for Part 1 only Medical professionals of Shinshu University Hospital (except persons who are directly involved in this trial or the prior clinical trial) and patients with retinal diseases who regularly visit Shinshu University Hospital. Inclusion criteria for Part 2 only DME patients enrolled in the prior clinical trial.

Exclusion criteria

Exclusion criteria: Exclusion Criteria common to Part 1 and Part 2 - Subjects with photosensitivity. - Subjects with eyes that cannot be adequately evaluated by OCT because of opacity in the anterior segment or ocular media associated with cataracts, etc. - Subjects who cannot correctly use the investigational device or tablet. - Subjects who have no internet connection at home (except subjects who use the investigational device only in the study site in Part 1).

Design outcomes

Primary

Measure	Time frame
Percentage of retinal monitoring at home.	—

Secondary

Measure	Time frame
Difference (Initial date of examination with the research device and the date 4 weeks later) between CST measured by the stationary OCT and the retinal thickness in the center automatically measured by the investigational device. Change from baseline to each time point (Initial date of examination with the research device to the date 4 weeks later) in CST measured by the stationary OCT and that in the retinal thickness in the center automatically measured by the investigational device. Change from baseline at each time point after administration of Faricimab (Initial date of examination with the research device to the date 4 weeks later) in the retinal thickness in the center automatically measured by the investigational device. Usability of the investigational device evaluated based on the patient-administered questionnaire (DME patients).	—

Measure

Time frame

Difference (Initial date of examination with the research device and the date 4 weeks later) between CST measured by the stationary OCT and the retinal thickness in the center automatically measured by the investigational device. Change from baseline to each time point (Initial date of examination with the research device to the date 4 weeks later) in CST measured by the stationary OCT and that in the retinal thickness in the center automatically measured by the investigational device. Change from baseline at each time point after administration of Faricimab (Initial date of examination with the research device to the date 4 weeks later) in the retinal thickness in the center automatically measured by the investigational device. Usability of the investigational device evaluated based on the patient-administered questionnaire (DME patients).

—

Contacts

Public ContactTakao Hirano

Shinshu University Hospital

takaoh@shinshu-u.ac.jp+81-263-37-2789

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026