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Accuracy evaluation of an eye-drop bottle sensor for detecting eye-drop instillation behavior

A prospective evaluation of the accuracy of an eye-drop bottle sensor for detecting eye-drop instillation behavior using 0.2% fluorescein ophthalmic solution and contact lens staining - Fluorescein-based evaluation of an eye-drop bottle sensor

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000061457
Enrollment
100
Registered
2026-05-07
Start date
2025-06-17
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

Various ophthalmological diseases including glaucoma

Interventions

Participants will wear a non-powered protective contact lens before eye-drop instillation. A magnified image of the eye will be obtained using a slit-lamp microscope before instillation. Participants

Sponsors

Tsukazaki Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. An outpatient at Tsukazaki Hospital 2. Patients who have received an explanation of the study and provided written informed consent. 3. Patients who are able to perform eye-drop instillation while wearing a protective contact lens according to the study procedures.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of hypersensitivity or allergy to fluorescein sodium. 2. Patients for whom contact lens wear is difficult or inappropriate. 3. Patients with active conjunctivitis, severe corneal epithelial disorder, ocular infection, or other ocular conditions that may interfere with the study procedures. 4. Patients judged by the principal investigator or sub-investigator to be unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
The proportion of participants in whom the eye drop is judged to have actually entered the eye, based on contact lens staining after administration of 0.2% fluorescein ophthalmic solution, among those classified by the eye-drop bottle sensor and deep learning algorithm as having performed eye-drop instillation behavior.

Countries

Japan

Contacts

Public ContactKazuaki Nishimura

Tsukazaki Hospital Ophthalmology

k.nishimura@tsukazaki-eye.net0792-72-8555

Outcome results

None listed

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