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Published on: March 23, 2016
Efficacy and Safety of a Magnetic Device for Temporary Management of Blepharoptosis: Single-Arm Open-Label Trial
Ching-Feng Lien1,2, Bor-Shyh Lin3, Tzong-Ming Wu4
1Department of Otolaryngology-Head and Neck Surgery, E-Da Hospital, I-Shou University, Kaohsiung, Taiwan.
Objective:
This study developed a feedback-enabled magnetic device for the management of blepharoptosis and conducted a clinical trial to evaluate its efficacy and safety.
Study Design:
Prospective, two-center, single-arm, open-label clinical trial.
Setting:
Tertiary referral centers.
Methods:
A device primarily comprising an optical sensor, a permanent electromagnetic actuator, and an iron sheet was developed. The palpebral fissure height (PFH) was measured, and the corrective gain of the paralytic upper eyelid was calculated. Efficacy was evaluated through symmetrical blinks, the corrective gain, and the electrical activity of the frontalis muscle. Safety was evaluated through subjective sensations and complications.
Results:
A total of 16 volunteers were recruited. After device-assisted correction, the patients reported subjective improvement of peripheral vision, and the mean PFH increased from 3.4 ± 1.6 to 7.2 ± 1.4 mm, with a mean gain of 3.7 ± 0.9 mm (range: 2.0-5.0 mm). The device could lift the paralytic eyelid without causing severe discomfort or complications. It also showed effects on the electrical activity of the frontalis muscle. Over the periorbital skin, posttest erythema was observed in one patient, mild hot sensation in two, and mild warm sensation in five. Subjective and objective evaluation of six patients who underwent two trials revealed no significant difference between the first and second trials (P > .05 for all seven items).
Conclusion:
The concepts used in this device may provide the basis of a future device that may be of use in patients with blepharoptosis who are not suitable candidates for surgical correction. TRIAL REGISTERED AT CLINICALTRIALS.
Gov Prs:
Registration number: NCT03812016.
