The Magnetic Levator Prosthesis for Temporary Management of Severe Blepharoptosis: Initial Safety and Efficacy

磁力提上睑假体用于暂时治疗重度上睑下垂:初步安全性和有效性

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Abstract

PURPOSE: We further optimized and evaluated the safety of the magnetic levator prosthesis (MLP) for temporary management of severe blepharoptosis, and compared efficacy and comfort against the ptosis crutch. METHODS: The interpalpebral fissure (IPF) of participants (n = 12) with ptosis was measured during attempted eyelid opening, volitional closing, and spontaneous closing with no device, ptosis crutch, or the MLP. A 10-point scale documented comfort. Additionally, a 20 minute and then 1 week trial of the MLP was offered. Safety measures were skin erythema rating, change in visual acuity, and change in corneal staining. RESULTS: The MLP and crutch opened the eye (IPF 11.2 and 9.3 mm), but the MLP allowed better volitional closure (IPF 1.0 vs. 4.9 mm, P = 0.009), but was no better in allowing spontaneous blink (IPF 7.5 vs. 7.7 mm, P = 0.722). Both devices were equally comfortable (both median 8/10 comfort, P = 0.46). With extended use, opening with the MLP showed IPF 9.24 mm at 20 minutes and 9.46 mm at 1 week, and volitional closure was IPF 0.95 and 0.52 mm, respectively. Closure on spontaneous blink improved with extended wear to IPF 5.14 and 5.18 mm, respectively (P = 0.002). Two participants exhibited moderate skin erythema and one had increased corneal staining without change in acuity. CONCLUSIONS: The MLP is safe and feasible for temporary correction of severe ptosis. TRANSLATIONAL RELEVANCE: First group data in patients showing successful reanimation of the eyelid with magnetic force.

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