Seeing is Believing

It is said that a picture is worth a thousand words. Seeing that picture is made possible by the cornea — a transparent, dome-shaped tissue that sits at the front of the iris (colored part of the eye) and the pupil (the black dot in the iris).

The cornea measures 12mm (0.47 inch) horizontally and 11mm (0.43 inch) vertically when viewed from the front.

Light enters the eye through the cornea and travels to the retina, then to the optic nerve, which sends electric pulses to the brain. These signals are then processed into images that allow us to see.

But the cornea also has another function. It serves as a barrier against dirt, germs, infections and other things that may damage the eye.

Diseases affecting the cornea are a major cause of blindness worldwide. According to the World Health Organization, over 30 million people in the world are legally blind from corneal injury and disease and approximately 2 million new cases of corneal blindness are reported each year.

A recent study published in JAMA Ophthalmology assessed that there was a great shortage of donated corneas — with only one cornea available for 70 patients.

That statistic will soon change with the invention of a synthetic cornea by Dr. Gilad Litvin, in Israel.

Dr. Litvin, can you tell us about your background and practice?

I studied medicine at the Hadassah Medical School in The Hebrew University, Jerusalem.

After I completed my residency at the Meir Medical center in Kfar Saba in 2009, I worked as a fellow for two years, specializing in retinal surgery. Subsequently, I completed three years of postgraduate studies in Ophthalmology at the Sackler Faculty of Medicine at Tel Aviv University.

My first patent for an implantable device was drafted in 2011 for the treatment of glaucoma.

I am the sole inventor of CorNeat KPro (synthetic cornea) and the CorNeat EverPatch (a synthetic tissue).

My time is divided between practicing ophthalmology, research and development, and my biochemical inventions.

What made you think of inventing a synthetic cornea?

I am an inventor by DNA and throughout my life I’ve always found solutions for various problems. Even when I was a medical student I had a lot of ideas, some of which ended up becoming good products.

Corneal blindness was a specific interest of mine from the beginning of my residency. I came to realize that there was a real need to help people with this condition.

Until now, the only way to transplant a cornea would be if a doctor harvested tissue from deceased individuals or from animals, and transplanted it into a recipient who was blind. All of these tissue products degrade over time and, therefore, provide only a temporary solution to the problem. That method is not scalable; plus, some people don’t want to donate their organs. Additionally, there is a variety of challenges for this procedure.

(CorNeat Vision)

Tell us about the process that led you to invent the CorNeat KPro.

An acquaintance asked me to a attend a meeting where he was going to assess a new type of chemical engineering technology. While I sat there, it dawned on me that this technology had many potential applications in medicine and, specifically, ophthalmology. I decided to invest time reading up on chemical engineering. At some point, I connected the two: cornea disease and blindness with the technology that may assist in solving it. Then I drafted a patent, tested it on rabbits and perfected it.

Which patients are able to have a synthetic CorNeat KPro implant?

  1. People who have been wounded in the cornea. It never heals in a transparent way but rather, like the white part of the eye. Therefore, the scar is opaque and you don’t see clearly.
  2. Those who have had damage to the transparency and optical performance of the cornea.
  3. Those suffering from any type of trauma, as seen in children who have accidentally been poked in the cornea with the tip of a pencil. That generally leaves a very bad scar and results in the need for a cornea replacement.
  4. Those who have been in ndustrial accidents, e.g., when the cornea is unprotected by goggles that shield workers from grinding wheel sparks and other particles.
  5. People who have had corneal herpes are unsuitable candidates for a donated corneal transplant because the virus can reappear on the patient’s cornea following the transplant. However, these candidates are suitable candidates for the CorNeat KPro because the product is completely synthetic and therefore it cannot become infected with the herpes virus.
  6. People with genetic conditions like Keratoconus, Fuchs Distrophy, etc., generally require a synthetic corneal implant.
  7. Infections are another cause that may require a CorNeat KPro corneal implant. This could come from wearing contaminated contact lenses or foreign bodies.
  8. If a patient has had a cornea transplant in the past and it’s been rejected, then they are suitable candidates for the CorNeat KPro implant.

There are various other medical conditions that cause a patient to be unsuitable.

It’s important to note that damage to a cornea can be external, like trauma, infections, etc. But it can also be internal, through various degenerative conditions.

The CorNeat KPro. (CorNeat Vision)

Which conditions cause people to be unable to have a CorNeat KPro implant?

  1. Damage to other parts of the eye that eliminate potential vision.
  2. Uncontrollable inflammation or infectious diseases of the eyeball and the orbit (the bony cavity that houses the eyeball) surrounding it.
  3. Malignancy of the orbit.

Regrettably, 55% of humanity has no access to corneal tissue whatsoever. Therefore, the No. 1 reason a patient will not be a candidate for a cornea transplant is because there is a lack of tissue. But if you have a synthetic solution that does not require harvesting tissue from a deceased person, then that has the potential of becoming a scalable solution.

How long does the procedure take?

So far we have performed three implants in humans under general anesthetic. The first one took an hour and 20 minutes and the last one took 30 minutes. I believe that, over time, surgeons will use local anesthetic so it will cut down on surgical time even more.

Are you training doctors to perform this procedure?

A couple of sites are going to be opening in the coming weeks in Canada (Vancouver and Toronto) to initiate clinical trials. Due to travel restrictions I am unable to travel to train surgeons for these trials. To tackle this problem we have developed a system called RSVP — Remote Surgical Virtual Presence — where we connect a microscope in Toronto to a data streaming unit in Israel that transmits the optical image in 3D with sub-second latency. That enables me to see exactly what is happening during the procedure and to correct surgeons in a timely fashion. Each training session lasts two to three hours.

Is it only surgeons in Canada that you are training?

Submissions are underway with the FDA for approval of sites in the USA (Los Angeles and Cincinnati), Netherlands (Amsterdam and Maastricht), France (Paris and Montpellier), and China.

What are the signs of a rejected cornea?

When the eye becomes inflamed, like pink-eye; deterioration of vision and pain.

What is your success rate?

At this stage, we don’t have statistics, as we are undergoing clinical trials. We can only talk about the success rate in rabbits.

How long does a synthetic cornea last?

It is supposed to last a lifetime.

How soon after surgery can a patient see?

Since our device is a synthetic lens, the minute you take off the bandages you are supposed to achieve your full visual potential. In cases where all other elements of the eye are intact, you can achieve 20/20 vision the day after the procedure. Our first patient saw the day after surgery when we removed the bandages.

What was the first successful operation like? Tell us about your reaction and the patient’s. How did the patient and his family react?

This was a very emotional moment. It was a culmination of five years of hard work. After we removed the bandages from our first patient, a 78-year-old male, he was able to see, which brought tears to our eyes.

The patient and his daughter were also very emotional. This patient has been blind for the past decade. For the first time in his life, he was able to see some of his grandchildren. He can now make his own coffee, enjoy the view from his terrace in Haifa, see his friends, and use his phone.

We only operated on one eye because the clinical trial setting allowed recruiting patients for a single eye procedure, plus his other eye had no potential. The shift from being completely blind to being able to see has changed his life dramatically.

What does it feel like to be a messenger of G-d to be able to help restore sight to people?

In Judaism, I’ve always stated one thing when treating my religious patients:

Iver chashuv k’met — A blind person is regarded like a dead person. And this points to the fact that curing blindness is like pikuach nefesh. This is the highest thing that we hold dear in Judaism — the gift of life. I believe the gift of vision and sight is similar to the gift of life. I don’t know if I am a messenger, but I find it a humbling experience to be present in these moments when I see a person’s life being changed for the better. I am privileged to take part in such projects.

Are you currently working on any other inventions?

The CorNeat EverPatch — the first nondegradable synthetic tissue that integrates with our body in surgical procedures — is currently under clinical trials. So far it has been implanted in seven patients with great results.

Additionally, we have drafted eight different patents and are currently working on four projects: the CorNeat eShunt — a solution for glaucoma, and the CorNeat gPatch — a solution for gingival recession. We have also drafted an IP for various other devices that we are developing.

What is your device made of?

The optical part is made of PMMA — Poly (methyl methacrylate) — the transparent acrylic plastic used for car windows and devices like smartphone screens. It is very lightweight, very strong, UV resistant, shatter-resistant and doesn’t discolor over time.

For the integrating skirt, we use a non-degradable polymer mix that is very inert and has very high tensile strength and flexibility.