Purpose: Blepharoptosis is a common oculoplastic condition defined as incomplete opening of the upper eyelid. Although surgical approaches have become the mainstay for correction, they often fail to improve blink function. The purpose of this study was to develop an adjustable magnetic levator prosthesis (aMLP) as a non-surgical treatment option for severe ptosis, that allows blink reanimation. Methods: Magnetic force required to perform blink reanimation was characterized by evaluation of eye opening and closing using inter-palpebral fissure (IPF) outcomes with various combinations of eyelid array magnet and box magnets. The force that provided the optimal eye opening without limiting eye closing was selected for the development of the aMLP. The aMLP included an eyelid array magnet and an adjustable rotating spectacle magnet that allowed change in the magnetic direction, and hence change in the net magnetic interactive force between the spectacle and lid magnets. The clinical feasibility of the aMLP in improving eye opening without limiting eye closing was evaluated in ptosis patients through a proof-of-concept study using IPF and comfort outcomes. Results: Optimal eye opening and closing was achieved by a magnet-array combination providing 45gF in the tested ptosis population. Optimal size of spectacle magnet for aMLP was selected based on the simulations of rotating diametrically magnetized cylindrical magnets to achieve force ranges required for blink reanimation. The aMLP was able to modulate eye opening and closing with change in rotation (fitting) of the spectacle magnet in two ptotic patients. The best fitting of aMLP improved IPF opening without limiting eye closing (spontaneous or volitional blinking) with good comfort reported. Conclusions: Preliminary results suggest that the aMLP can correct ptosis without adversely affecting blink function. Further evaluation in a larger patient population is warranted. Translational Relevance: A non-surgical, proof-of-concept, adjustable magnetic treatment option for blink reanimation in patients with severe ptosis is presented.

EIP is a paid consultant for Strategic Intelligence Inc. KH and EIP are co-inventors on intellectual property relating the conceptual design of active magnetic prothesis for eyelid reanimation.

NCT03818204

Supported in part by the research project grant (National Institute of Health [NIH], R01EY029437, department of defense (W81XWH2210774, W81XWH2010916), and the research project grant (NIH, R01EY013124-21).

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

All experiments were conducted in accordance with the declaration of Helsinki and approved by the institutional review board of Mass General Brigham (formerly Partners Healthcare).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

All data produced in the present study are available upon reasonable request to the authors