Stopped: Although six patients completed the test using device prototype before Dec 2019, but due to the large size and shape, we failed to well miniaturize and manufacture a resilient system that stands the test of time for the future trial.
To develop a real-time wearable device based on the principle of magnetic force for temporary management of lagophthalmos, and evaluate its efficacy and safety, including synchronous blinks and eye closure, blurred vision, foreign body sensation over cornea or eyeball, burning or hot sensation over facial skin, and erythema or pruritus over eyelid, by performing a human trial on patients with lagophthalmos.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Changes in palpebral gap from the baseline.
Timeframe: 10 minutes after completion of the testing
Changes in visual acuity (blurred vision) from the baseline.
Timeframe: 10 minutes after completion of the testing
Discomfort of the eyeball and condition of the upper eyelid and facial skin based on a dichotomous Likert scale.
Timeframe: 10 minutes after completion of the testing
Changes in palpebral gap from the baseline.
Timeframe: 10 minutes after completion of the second testing within 12 months
Changes in visual acuity (blurred vision) from the baseline.
Timeframe: 10 minutes after completion of the second testing within 12 months
Discomfort of the eyeball and degree of the upper eyelid and facial skin based on a 3-point Likert scale.
Timeframe: 10 minutes after completion of the second testing within 12 months