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

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 eye opening and proportions of complete volitional blinks. Results: Of 16 patients randomized, 15 completed the crossover. MLP and tape equally improved eye opening over sham (MLP, 6.8 mm [95% confidence interval (CI), 5.2-8.4]; tape, 7.0 mm [5.4-8.6]; sham, 3.9 mm [2.3-5.5], all P < 0.001). Spontaneous blinks were significantly better with MLP (2.4 mm [95% CI, 1.5-3.7] compared to tape, 4.1 mm [2.6-6.5], P < 0.001). Incomplete volitional blinks were much more common when wearing tape compared to when wearing the MLP (P < 0.001), which was not different from sham. There was a significant perceived benefit of both MLP and tape (P < 0.001). There were three related nonserious adverse events over 3539 hours of tape use and two related nonserious adverse events over 4632 hours of MLP use. Conclusions: The MLP was superior to KT tape and sham for the treatment of severe blepharoptosis. Translational Relevance: First randomized controlled clinical trial of the MLP. (https://clinicaltrials.gov/study/NCT04678115?cond=Blepharoptosis&term=kinesiotape&rank=1, NCT04678115).