Tokyo, May 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061457) titled 'Accuracy evaluation of an eye-drop bottle sensor for detecting eye-drop instillation behavior' on May 7.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Tsukazaki Hospital

Condition: Condition - Various ophthalmological diseases including glaucoma Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to evaluate the accuracy of an eye-drop bottle sensor in detecting eye-drop instillation behavior by determining whether eye drops actually enter the eye when the sensor classifies the action as eye-drop instillation behavior. Basic objectives2 - Others

Intervention: Interventions/Control_1 - 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 will then instill 0.2% fluorescein ophthalmic solution using an eye-drop bottle equipped with an eye-drop bottle sensor. After instillation, another magnified image of the eye will be obtained using a slit-lamp microscope. If the contact lens is stained, the eye drop will be judged to have entered the eye. If the contact lens is not stained, the eye drop will be judged not to have entered the eye. After assessment, the contact lens will be removed. Data recorded by the eye-drop bottle sensor will be classified by deep learning as either eye-drop instillation behavior present or eye-drop instillation behavior absent.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key 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. Key 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. Target Size - 100

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2025 Year 06 Month 17 Day Date of IRB - 2025 Year 06 Month 17 Day Anticipated trial start date - 2025 Year 06 Month 17 Day Last follow-up date - 2025 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070325

Disclaimer: Curated by HT Syndication.