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A prospective study exploring the usefulness of the Smart Eye Camera

A prospective study of exploring the usefulness of Smart Eye Camera in oncology practice

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1042250078
Enrollment
70
Registered
2025-08-18
Start date
2025-12-23
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

Eye disorders caused by chemotherapy for various cancers

Interventions

Recording video of both eyes with the Smart Eye Camera

Sponsors

Kawakami Takeshi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) The individual must be 18 years of age or older at the time of consent acquisition. (2) Patients with any type of cancer who are starting palliative chemotherapy or postoperative adjuvant chemotherapy with the following drugs. - Tegafur Gimeracil Oteracil Potassium - FGFR inhibitors (pemigatinib, futibatinib, tasurgratinib) - datopotamab deruxtecan (3) The ECOG performance status must range from 0 to 2. (4) Expected to survive for 6 months or more after starting chemotherapy (5) Written informed consent must be obtained from the patient.

Exclusion criteria

Exclusion criteria: (1) Patients who need to wear contact lenses regularly as the lenses unusable by fluorescein staining. Patients who can remove the contact lenses on the day of the ophthalmological examination are eligible. (2) Patients who have the history of corneal diseases diagnosed by an ophthalmologist that make evaluation of fluorescein staining images difficult (corneal degeneration such as granular corneal degeneration and band corneal degeneration, and cases after corneal transplantation) (3) Patients who have had LASIK surgery less than one year ago. (4) Patients who have pheochromocytoma or paraganglioma. (5) Patients deemed unsuitable by the investigator.

Design outcomes

Primary

MeasureTime frame
Concordance rate between medical oncologists and ophthalmologists in the diagnosis of ocular adverse events after starting chemotherapy.

Secondary

MeasureTime frame
(1) Sensitivity and specificity of Smart Eye Camera for ocular adverse events (2) Concordance rate of ocular adverse events diagnosis between medical oncologists and ophthalmologists at the day of starting chemotherapy. (3) Proportion of patients with eye symptoms after starting chemotherapy (4) Proportion of patients with eye findings after starting chemotherapy (5) Recording time of videos by Smart Eye Camera (6) Quality of Smart Eye Camera videos. (7) Patient satisfaction.

Contacts

Public ContactTakeshi Kawakami

Shizuoka Cancer Center

t.kawakami@scchr.jp+81-55-989-5222

Outcome results

None listed

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