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PEMF for treatment of corneal disorders and injuries


Bruce Gelerter



The cornea is a unique biological tissue. It is normally clear, devoid of vascularization, and comprised of highly organized groups of cells and proteins which make up at least six layers wherein each cell type, protein, and layer performs specialized functions necessary for good vision. The layers of the cornea include: corneal epithelium, basement membrane, Bowman’s membrane, stromal lamellae, Descemet’s membrane, and the endothelium of the cornea. Injury to the cornea or disease of the cornea can lead to impaired vision and blindness.

Recalcitrant corneal ulcer represents a difficult vision-incapacitating condition for which no effective treatment exists today. These ulcers arise due to a deficiency or an absence of host factors important in wound healing including the lack of tissue perfusion such as a limbal ischemia after chemical burns, decreased corneal innervation and pain sensation (i.e., protective lid closure). Certain examples of corneal ulceration or susceptibility include neurotrophic corneal ulcers after herpetic infections and various dry-eye conditions that compromise the integrity of the ocular surface. Traditional therapies such as lubrication, contact-lens wear, tarsorrhaphy or conjunctival flap are often ineffective. Typically, these patients eventually become blind as a result of corneal melt, perforation or infection. Clearly new and much more effective means of treating these recalcitrant corneal ulcers, and other conditions of the cornea, are urgently needed.

When the cornea is injured, the healing process depends on many factors such as an adequate wound-healing response, a sufficient degree of innervation, and a perfusion of biological factors from limbal vasculature, pre-corneal tear films and the aqueous humor. Delayed wound healing in the cornea occurs in various conditions and may lead to impaired vision. Persistent corneal ulcers occur in instances such as poor tissue perfusion as in chemical injuries, neurotrophic ulcers (for example, due to herpetic infections, strokes or tumor), exposure keratopathy, and various dry-eye conditions that desiccate the ocular surface (e.g., collagen-vascular diseases, conjunctival scarring disorders, vitamin A deficiency, induced by certain medications, and lacrimal gland diseases).

In one example, recalcitrant corneal ulcers may not heal due to a compromised wound-healing response of the host. In order for a wound to close in a normal host, there must be a sufficient amount of stromal wound-healing response involving interaction between the stroma and epithelium containing layers. This includes the activation and migration of the overlying epithelial cells, leading to wound closure. In a compromised host, however, the stromal wound healing response is down-regulated and is insufficient to induce the amount of stroma-epithelium dialog necessary for wound closure. The PEMF treatments described accelerate the wound healing process in the cornea.

How does the PEMF 4000 affect the cornea?

One aspect of the PEMF 4000 is that the optimal PEMF parameters for accelerating the corneal ulcer and other corneal conditions were found to be different than the parameters previously used for enhancing broken bones and wounds in soft tissue. Thus, one embodiment of the present invention provides a method for treating a condition of the cornea, comprising: a treatment regimen including a plurality of wave packets having a packet duration, a packet frequency, a pulse intensity, a delay time between packets, and a treatment duration. The preferred packet duration is approximately 1 second. It is preferred that a wave packet includes one or more electromagnetic pulses having an electromagnetic pulse duration. In certain embodiments, the electromagnetic pulse comprises a full square wave pulse.

A preferred electromagnetic pulse duration is approximately 10 milliseconds (ms) and 20 milliseconds in certain other embodiments. In certain preferred embodiments, the preferred delay time (between packets, for example) is approximately 2.5 seconds. In certain preferred embodiments, the pulse intensity is approximately 20 gauss. In certain preferred embodiments, the frequency is changed over time. In certain preferred embodiments, the treatment duration is approximately 30 minutes total and is divided up into 5, approximately 6 minute blocks, wherein the frequency is 3 Hz for a first 6 minute block, 5 Hz for the second six minute block, 7 Hz for the third 6 minute block, 9 Hz for the fourth 6 minute block, and 11 Hz for the fifth 6 minute block. The number of pulses (electromagnetic pulses) in a packet is generally determined by the packet frequency and the packet duration.

Without being bound to mechanism or theory, it is proposed that PEMF results in improvements in conditions of the cornea through a variety of effect including, but not limited to: induction and acceleration of corneal keratocyte activation and migration; induction of corneal fibroblast transformation, proliferation, and migration; induction and acceleration of corneal epithelial cell proliferation or migration in the epithelial layer of the cornea; induction of corneal endothelial cell proliferation and migration; enhanced regulation of fluid pumping in and out of the corneal (especially the stromal lamellae) by the corneal endothelial cell layer; increased corneal nerve stimulation, and through the induction of tear production from the lacrimal glands of the eye. Additionally, up-regulation of stromal cellular activities is believed to result in an increased stromal-epithelium dialog that leads to the activation and accelerated migration of overlying corneal epithelium and corneal wound closure.

Specific cellular and molecular responses that may mediate biological responses described in the present invention include: an up-regulation of DNA synthesis and mRNA transcription of protein factors involved in wound healing; reduction of the doubling time of fibroblasts and endothelial cells in cell cultures; induction of fibroblast differentiation in cell cultures; augmentation of collagen synthesis, angiogenesis, and bacteriostasis in wound healing; and regulation of membrane transport, receptor expression and signal transduction pathways.


Certain conditions, disorders, and diseases of the cornea that can be treated by way of the PEMF 4000, include, but are not limited to: corneal injury, corneal ulcer, burns, conjunctivitis, abrasions, edema, opacity, transplant (i.e., healing following transplant), dry eyes, infections in general, herpes simples, herpes zoster (shingles), giant papillary conjunctivitis, keratoconus, pterygia and pingueculae, and damage due to laser surgery (e.g., laser vision correction including phototherapeutic keratectomy, LASICS, etc.).

Although these preferred embodiments of the invention are described, one with skill in the art will realize that variations can be made which yield similar results in terms of healing of corneal ulcers or other corneal conditions.

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