A Single-Center Sham and Active-Controlled Double-Blind Randomized Crossover Trial of the Magnetic Levator Prosthesis for Severe Blepharoptosis.

ABSTRACT:

Purpose

To evaluate the safety and efficacy of the magnetic levator prosthesis (MLP) relative to active control with KT Tape, an elastic therapeutic tape used clinically to mechanically open the lids, and to a sham MLP worn in-office only.

Methods

This was a double-masked, randomized crossover single-center trial of patients with severe unilateral or bilateral paralytic blepharoptosis defined as occlusion of the visual axis without frontalis recruitment. Patients were allocated to MLP or tape first and then crossed over after 2 weeks of use and a 2-week washout. Primary outcome was maximum eyelid closure on spontaneous blink measured in video frames with ImageJ. Primary patient-reported outcome was the Glasgow Benefit Inventory and, secondarily, comparison of the amount of e

SUBMITTER: Houston KE 

PROVIDER: S-EPMC11817847 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature