Study of a Feedback-Enabled Magnetic Device to Treat Blepharoptosis in Adults

What this Trial Is About

Researchers are studying a new feedback-enabled magnetic device designed to temporarily manage blepharoptosis, a condition where the upper eyelid droops. The study aims to evaluate how well the device improves eyelid height, symmetry of blinks, and reduces symptoms like visual field obstruction, blurred vision, and discomfort on the eyelid and surrounding skin. The safety and effectiveness of this device will be compared with outcomes from patients who undergo surgery for the same condition. The device includes near-infrared sensors, a magnetic actuator, an iron sheet for attaching to the affected eyelid, and a biosignal module. During the study, participants will use the device for sessions lasting about 120 minutes each. Researchers will measure the distance the eyelid lifts and assess muscle activity related to eyelid movement. Both subjective sensations and any side effects will be monitored to evaluate the devices performance. Participants will have their eyelid measurements taken before and after using the device, along with assessments of visual field changes and muscle activity. These evaluations occur shortly after device use and include checking for any skin irritation or discomfort. The study also includes follow-up examinations comparing device use with surgical treatment outcomes at one and six months. The total participation time for each device use session is about two hours, with longer-term follow-up for surgical cases.

A Feedback-enabled Magnetic Device for Temporary Management of Blepharoptosis