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

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.

SUBMITTER: Houston KE

PROVIDER: S-EPMC5777174 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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

Houston Kevin E KE Tomasi Matteo M Amaral Christina C Finch Nicole N Yoon Michael K MK Lee Hang H Paschalis Eleftherios I EI

Translational vision science & technology 20180119 1

<h4>Purpose</h4>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.<h4>Methods</h4>The interpalpebral fissure (IPF) of participants (<i>n</i> = 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 minu ...[more]

PMID: 29367892

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Project description:PurposeTo assess the safety and efficacy of chronic electrical stimulation of the retina with a suprachoroidal visual prosthesis.MethodsSeven normally-sighted feline subjects were implanted for 96-143 days with a suprachoroidal electrode array and six were chronically stimulated for 70-105 days at levels that activated the visual cortex. Charge balanced, biphasic, current pulses were delivered to platinum electrodes in a monopolar stimulation mode. Retinal integrity/function and the mechanical stability of the implant were assessed monthly using electroretinography (ERG), optical coherence tomography (OCT) and fundus photography. Electrode impedances were measured weekly and electrically-evoked visual cortex potentials (eEVCPs) were measured monthly to verify that chronic stimuli were suprathreshold. At the end of the chronic stimulation period, thresholds were confirmed with multi-unit recordings from the visual cortex. Randomized, blinded histological assessments were performed by two pathologists to compare the stimulated and non-stimulated retina and adjacent tissue.ResultsAll subjects tolerated the surgical and stimulation procedure with no evidence of discomfort or unexpected adverse outcomes. After an initial post-operative settling period, electrode arrays were mechanically stable. Mean electrode impedances were stable between 11-15 kΩ during the implantation period. Visually-evoked ERGs & OCT were normal, and mean eEVCP thresholds did not substantially differ over time. In 81 of 84 electrode-adjacent tissue samples examined, there were no discernible histopathological differences between stimulated and unstimulated tissue. In the remaining three tissue samples there were minor focal fibroblastic and acute inflammatory responses.ConclusionsChronic suprathreshold electrical stimulation of the retina using a suprachoroidal electrode array evoked a minimal tissue response and no adverse clinical or histological findings. Moreover, thresholds and electrode impedance remained stable for stimulation durations of up to 15 weeks. This study has demonstrated the safety and efficacy of suprachoroidal stimulation with charge balanced stimulus currents.

Dataset Information

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

Publications

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

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