Electromechanical Reshaping of the Cornea – A Future Non-invasive Refractive Technology?

The potential ophthalmic application of electromechanical reshaping has recently been considered. This report reviews emerging work on this new technology, which does not require surgical tools or lasers, but instead utilizes electrical current and hydrolysis to reduce intermolecular bonds, thereby decreasing biomechanical strength and allowing tissue to be molded into a new shape. Once the stimulus is removed, the original tissue strength returns. This technology has been initially investigated for application on cartilage and remains experimental.

Application of this technology to the cornea for refractive purposes was discovered incidentally and is still in an early stage, not yet ready for human trials. So far, exploratory studies have been performed on rabbit eyes in vitro. The theory is that this novel technology can transiently soften cornea to the point when a mask of a desired shape is placed over the cornea to change its refractive power and, if needed, eliminate irregular astigmatism.

If successful, this non-invasive technology has enormous potential to change the world of refractive surgery and, also, the field of contact lenses.

electromechanical reshaping, electrochemistry; cornea, refractive vision therapy

A laser-free LASIK alternative is sweeping the research world, garnering a great deal of excitement. This new technique harnesses electromechanical currents to make the cornea temporarily moldable allowing a custom 3D printed mold to reshape the eye into a desired shape and refractive status. Due to its novel methodology, this approach can treat hyperopia, myopia, and even irregular astigmatism. However, there are currently many unknown limitations, and further research is still required to ensure long-term corneal stability and safety.

Currently, there are very few options for correcting a patient’s refractive error. While LASIK and PRK procedures are established and approved, both procedures result in permanent damage to existing healthy tissue, leaving the patient at a risk for corneal ectasias, corneal erosions, dry eye, and an increase in higher order aberrations.¹ Other treatment options such as orthokeratology lenses can be useful, especially in the management of myopia management. However, this treatment option is temporary and requires daily use of the lenses (worn overnight) to the point of visual fluctuations.² Typically, the orthokeratology lens is worn overnight, which increases the risk for microbial invasion of the cornea.² Electro­mechanical reshaping can potentially bridge this gap by offering lasting correction with minimal tissue damage, although the permanency of change has yet to be demonstrated over time.

The use of electromechanical reshaping (EMR) as medical therapy is not new. While it has been researched extensively to treat other conditions, including reshaping cartilage,^3,4,5,6,7 it remains an emerging field with many questions that need to be investigated. EMR has previously been applied to rabbit septal cartilage to assess tissue flexibility.^4,6 The experiment was successful in molding the tissue to its desired state by causing the hydrolysis of water, inducing redox reactions.⁴ It appears that the electrochemical reactions lead to the reduction of internal stress of the stromal tissue by offsetting the electric charge balance between collagen and proteoglycan matrix.³ In Hill’s experiment on correcting refractive error, rabbit corneas were reshaped in a similar mechanism where water was first electrolyzed.¹ The resulting influx of protons into the extra-cellular matrix (ECM) disrupts the existing ionic bonding network, increasing corneal malleability. Once the custom mold is placed on the surface, the eye is doused in a liquid to restore its physiological pH, thereby reestablishing the ECM and completing the reshaping process.¹ Hill’s lab found that new radius of curvature of the molded cornea was identical to that of the custom mold used, reinforcing its initially durable and reproducible change in shape. A major benefit to this form of corneal reshaping is that it has not yet shown signs of scarring, haze, or damage to anterior limiting lamina, a non-­regenerative layer damaged by LASIK and removed by PRK.¹ While the researchers predict that this will be a permanent change, there are no long-term studies available.

Although the Hill study provides possible evidence for a laser free, non-invasive alternative to refractive surgery, many limitations and considerations need to be investigated further. In one study, the first attempt at balancing the front surface was done using hypochlorite, which resulted in oxidative damage to the cornea.¹ Switching to a phosphate buffer fared better causing minimal disruption of the macromolecular structure. They also found that a pulse sequence rather than a short continuous stimulus also was gentler on the tissue. Despite these initial changes, confocal microscopy did show some tissue necrosis, especially affecting stromal keratocytes. Although sparsely populated in the corneal stroma, keratocytes are responsible for maintaining homeostasis and preventing the loss of corneal transparency after LASIK and PRK.¹ The anterior loss of keratocytes after an excimer laser procedure has been shown to be temporary.⁸ Any damage should be considered as it can lead to post-procedural haze and scarring. While there are a lack of studies studying the effect of EMR on keratocytes, studies on reshaping cartilage have shown to have little to no effect on chondrocytes, a functionally similar cell that leads to scarring in cartilage.⁷ Like keratocytes, it can be difficult to study the effect of EMR on chondrocytes as their density is also low. However, some studies are promising, as they show little to no difference to the damage of chondrocyte viability rate between EMR and traditional reshaping techniques, which typically employ surgical tools.^4,5,6 Despite this, the tissue surrounding the electrode, including chondrocytes, are still at the highest risk of localized tissue damage at a rate proportional to the magnitude of the voltage used and the extent to which it is being reshaped.^5,6 Studies on rabbit septal cartilage EMR found that chondrocyte damage occurred at the fastest rate within the first three weeks in culture.⁶ Researchers are considering other options of electrodes rather than aluminum as well as insulating the chondrocytes in cartilage surface to minimize the local damage.

Before translating this procedure to humans, it is also critical to consider other factors of the human corneal health. Rabbit eyes, which served as the experimental model, lack the distinctive anterior limiting lamina (ALL) that exists in humans, which is 8-10 um thick. Instead it is replaced by a thin (~0.5 um) layer of scattered collagen fibers.⁹ In an experiment studying corneal dystrophies, the poorly developed ALL in a rabbit made it difficult to differentiate between stromal avascular fibro-cellular pannus and the epithelium.^9,10 Consequently, any damage to the front surface of the rabbit eye may not be able to predict adverse effects to either the human corneal epithelium or ALL. Other considerations include the persistence of corneal basal cell density, corneal endothelium density, any changes to the tear film, the ability to control the depth of penetration depending on corneal thickness.

Conclusion

Electromechanical reshaping of the cornea without the use of surgical tools or lasers potentially represents a groundbreaking step toward the future of refractive correction. It can minimize damage to the cornea, reducing the risk of corneal ectasias, or the need for daily treatment in the form of orthokeratology lenses. However, with the current limited knowledge, it is difficult to assess the treatment potential in humans due to the lack of information on keratocyte homeostasis, local tissue damage, long term effects, and the variations in anatomy between a human and animal model. Even so, electromechanical reshaping of the cornea stands out as an innovation with remarkable potential and will be interesting to follow in its evolution.

LASIK and PRK have achieved worldwide acceptance but should not be considered the final protocols for permanently changing the refractive error of an eye. One day a new technology will emerge to take over and perhaps this new day will arrive sooner than many would expect.

Conflict of interest

The author declares that there is no conflict of interests regarding the methods and devices mentioned in the article.

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