Navigating the controversy: Exploring keratopigmentation

Alexander Movshovich, MD, PhD, a specialist in keratopigmentation, sat down to talk about the controversy surrounding the procedure after it went viral on social media.

Video Transcript

Editor's note - This transcript has been edited for clarity.

Martin David Harp:

I'm Martin Harp, Associate Editor of Ophthalmology Times. I'm joined today by Dr. Alexander Movshovich from Kareto NYC. He's a doctor specializing in keratopigmentation, a procedure that's gone viral recently on social media, specifically on TikTok. It has also received quite a bit of backlash from other doctors, Dr. Movshovich, can you please tell me what is keratopigmentation?

Alexander Movshovich, MD, PhD:

Karetopigmentation, it's basically one of the ways of changing of the color of the eye. And, to tell you the truth, after my research, it's the most reliable and least dangerous procedure. Even the word dangerous probably not a good word for that because it's very safe.

The idea of keratopigmentation is to basically place the pigment inside of the cornea, which would hide, or shadow rather, the underlying color of the eye. To understand the volume of that, I would say the i ris is within the eye and cornea is the most external transparent part. So, when we were saying about the color change of the eyes, we have to separate all the procedures by intraocular and extraocular, all intraocular procedures are prone for intraocular complications, and obviously extraocular are not prone for them. So that's a common mistake when people say oh, you can be blind from this. You cannot be blind from that.

Martin David Harp:

Keratopigmentation is different from you know, iris implants, or even scleral tattooing. But keratopigmentation does have a secondary alias on the internet, it may not be correct as eye tattooing. What do you think about when you hear people consider keratopigmentation eye tattooing?

Alexander Movshovich, MD, PhD:

I wouldn't even put these two things together. Number one, because tattooing implies that every time you put the dye inside of the tissue, you create a channel. So this channel allows this pigment to leak. With keratopigmentation, it's a channel which is closed.

Basically you have two small openings to enter this channel. So there is no leaking there. At least cosmetically observable. Under microscope, you can see mild leakage, which is only seen under high magnification. Tattooing of the cornea, if we're really using this term, referring to historical things. When there was no laser surgery, when it was like really, real tattooing of the cornea. And that's had all these drawbacks and possible complications, infections, and inflammation because it's multiple puncturing. Here, you don't have all this. The laser creates channel painlessly in only two small openings there.

There are two types of implants one, which is really dangerous. Really, really dangerous, 80% of them after 3 years removed. Because of the damage to the eye, either iris or the cornea and here you can have opacity, uveitis, hemorrhages, glaucoma, cataract, whatever, you name it, right.

The second one which is approved right now, it's a completely different animal. It's an implant which is placed inside of the back of the lens. It's like an intraocular lens. So but in order to use this, you need to, in order to see that, you need to eliminate the iris. You basically need to chew the whole iris out. In my mind, it's pretty aggressive surgery. To me, as a surgeon, it's a little bit more aggressive than this.

So basically keratopigmentation something more similar to the LASIK or SMILE, it's just pigment in. You say, well, yeah, the pigment could be the problem. It could carry the infection. It could carry a reaction, all of this is true. But listen, so does every surgery. If you don't go with the sterility, if you don't have the purified properly, you know, proven purified and CE marked or FDA marked pigments. So it's not like tattooing like on the skin. When it's not necessarily [by] doctors not necessarily in sterile situation, not necessarily sterile pigment. It's completely different animals. It's called tattooing.

It's like I would say food. Food could be meatballs, it could be cake. It's all food right? You cannot mix these things. People in majority of articles like especially lay articles, completely mixing it.

Martin David Harp:

The American Academy of Ophthalmology came out and warned against keratopigmentation. This was actually on January 29. They listed a laundry list of risks associated with the procedure. I can read you them.

They said that it risks damage to the cornea that can lead to cloudiness, warpage, fluid leakage and vision loss. Light sensitivity. Reaction to the dye causing inflammation, uveitis or blood vessel growth into the cornea. Bacterial or fungal infection which can produce corneal scarring or vision loss. Uneven distribution into the eye. Leakage of dye into the eye and color fading due to the dye moving, I want to know as someone who has been doing this for as long as you have and you are, you know, one of the only clinics in the US to be specialized in this. What is your outlook on what the AAO says about the procedure?

Alexander Movshovich, MD, PhD:

A lot of time in TikTok or Instagram or Facebook, people completely mixing all these things. They're claiming that keratopigmentation has a complication with intraocular implants, which is absolutely not true, because it's two completely different animals. You cannot compare, you know, oranges to apples because it doesn't work the same way.

And keratopigmentation has the history of more than 15 years in Europe. With the pigment which we're using now, it's a third generation pigment, which is done from mineral, there is no reported serious complications. When they're saying there is ingrowth of the vessels, the infection, the scarring ... while any manipulations on the cornea technically can result in that, especially if the cornea is diseased. If you're talking about healthy cornea, it's basically something similar to the LASIK procedure or SMILE procedure because the laser creates the channel or the split of the cornea the same way.

So saying that, if it's done in sterile circumstances, obviously done with the sterility. If you use sterile third generation pigments, there are no reports in the world depicting the blindness or even the corneal opacity. Especially leaking inside of the eye, because it's within the cornea. There is no path inside of the eye, there is no leakage inside of the eye. If anything possible, very minute leakage as I told you, which you only can see with a slit lamp examination, which is a microscope. Through this little openings. And that's limited to a very small amount which does not affect vision.

Secondly, I think it's dose dependent as well, not only pigment itself, but dose dependent. If patients, or clients or whatever you call it, I think it's patients still, require or demand very high intensity of the dye. It means that there's a lot of pigment there. So if you just take any medication like, you know, if you take a dose more than it's suggested, then it's going to be toxic. At this point I, out of my 5 years experience, and more than 750 cases, I only saw probably 5 cases of prolonged light sensitivity, or some kind of inflammation. And it's only in cases when it's a secondary surgery, when people demand additional pigment. With a first, with a one time surgery, I still didn't see any, well hopefully not going to be able to see it at all, but more than like 72 hours, sometimes a week. Because you're doing the procedure in the cornea, which is not vascularized it's only tissue. It's only getting the nutrition and oxygen by diffusion. So there is no ingrowth of the vessels unless you violate the vessels. Unless you already had some superficial vessels.

So healthy cornea, it's not prone for these things. At the same time, if we're talking about keratopigmentation for disease cornea, when it's sometimes in combination with tattooing. And that's also widely reported, especially in Spain by Dr. Alio, Jorge Alio. Then it is possible indeed because the cornea is already diseased, any irritation to that may result in some additional inflammation.

Martin David Harp:

And I'm actually very glad that you brought up Jorge Alio, because I was given literature to kind of get more in tune with keratopigmentation to kind of, like you said, not mix up what these procedures were. And I was given an article that he wrote actually for Ophthalmology Times, and it was publishedback in June of last year.

But even he in that article stated that it is a controversial topic and that for the specific reasons of purely cosmetic, and not for like someone who had a corneal disease or something like that, that the complete cosmetic aspect of it was viewed as controversial. And so, you know, when you see patients come to you, is it more or less for the cosmetic reason? Or is it because they have something that they actually do need fixed?

Alexander Movshovich, MD, PhD:

In my practices it is mostly cosmetical. I do have some numbers of patients who come for medical reasons and those medical reasons could be all albinism, they need filtration of the light, it could be some deformity of the iris, either traumatic or genetic. But in my practice comparing to his practice, definitely overweight cosmetical part.

If you do have some disease of the organ, this organ is more prone for other problems again. Because the integrity of the organ is already violated. More than that, I think the you know, mentioning of the uveitis and irritation for a long time again, is related, not to one surgery, and related not to the proper amount of the pigment. Because some people really wants to be like dragony, kind of like very bright. And this brings them out of ... It's like, you know, very often when I talk to them, I give them this example, just imagine you have the white wall, and you put the first layer color, right, so you see through this paint part of the white white wall. With a second layer you see less, with a third you see just a red paint. So same thing here, it's a paint, but this color is based on the minerals.

So collagen reacts with different minerals differently. So for instance, if you take blue color, it's really dead in a year. It fades more than anything else. Others I didn't really have much fading. I am basing my opinion out of this 5 years on more than 750 cases. And I'm telling you, the procedure performed 1 time, with the low to medium intensity of the colar doesn't bring you more than 72 hours of irritations or light sensitivity.

Martin David Harp:

These people that are young and getting this procedure. And if they are to then get glaucoma after the procedure, you know, 20 years down the line ... I was looking through your FAQ and I noticed that, you know, glaucoma treatment can be a little bit more complicated with this procedure done because it makes it so that you can only see through the...

Alexander Movshovich, MD, PhD:

Okay. Let me ask you this question because that was my question first. Because I didn't take glaucoma people until I made sure to myself and proven with the results. That visual field, which is one of the leading tests, well one of the leading tests as well as the photograph of the nerve can be done through the same opening, which I make 5.5 millimeters which is actually more than enough for cataract surgery, retinal surgery, retinal examination, gonioscopy which is a glaucoma test.

I actually have all these pictures. You know, I had couple of presentations on different societies. And actually I have accepted abstract for Association of Cataract and Refractive Surgeons in April, this April. Will be showing all this. So the answer to your question, all the testing, which is necessary for glaucoma, and other disease are possible through this opening because this opening not less than 5.5 millimeters.

Martin David Harp:

The procedure itself is not FDA approved. It's not covered by insurance, you know, looking forward into the future, do you see that this could become a more prominent procedure.

Alexander Movshovich, MD, PhD:

Number one, keratopigmentation consists of two parts. One part is creation of the channel. And that's off-label use of FDA approved protocol for ICRs, intracorneal rings. So basically, when you're saying off label, just change the parameters. A little larger, you may use different depths. So it's not very much different from the ICR protocol. So from this point of view, it's nothing to approve.

They approve the different parameters, but that doesn't make a difference in terms of procedure. The second part is a pigment. Pigment, which I use are produced in France. In France, or like in Europe rather, there is the similar to FDA - CE marking. Those pigments are CE marked. It means that they've been through all the pathology, embryology, you know, toxicity, toxicology. Everything was done before CE Mark was applied to this. So the fact that it's not FDA approved here is basically a time problem. We are working on the question of FDA approval of these specific pigments, and I know another company who is planning to do the same.

So I think FDA approval is a time question. I think it will be FDA approved. Will it be covered by insurance? I doubt that the cosmetical part will be because nothing cosmetical is covered. It's a choice.

Martin David Harp:

With it not being covered by insurance. You know, why would someone not just get colored contacts? I understand that there's a hassle of putting colored contacts in every single day and those sorts of things. But it's much less not to say invasive, but invasive and you can ... it's not permanent which keratopigmentation is.

Alexander Movshovich, MD, PhD:

Contact lenses are very good. I mean, you can easily can change the color. You can remove it, put them in. The only downside - 2 downsides. One people like after drinking and partying sleep with these contact lenses. That's not rarely, especially with the color consequence, because they're thicker, may result in damage of the surface of the cornea. Not detrimental, in majority of case it's infection. Sometimes it's ulcer. It's still treatable. But nevertheless, if you are proper about this, it's a very good choice.

You don't have to do anything permanent unless you want to wake up in the morning and say, I don't need contact lenses, I wanted this. I created the system, which allows me to remove about 50 to 60% of the pigment. So it's partially reversible. Also, you can substitute some other pigments, so it may change somewhat. If people are really unhappy with some blue, they will make it a little bit greener, I can do it. But listen, everything has a limitation. I would divide people who come in for this procedure problem into 3 categories, like usually people do.

One, I think the most important thing that's a lot of people born with idea, that's the wrong color of theirs. Like, you know, people sometimes born thinking that their gender is wrong. So they want to have something which they wanted their whole life. I would say probably about 20% of people would tell me, when I asked them the same question, would tell me I always was dreaming that it's going to be the possibility of doing it. And I spent ample time with them explaining this. Explaining all the same things which I'm explaining to you right now. Debating, not debating, but like, you know, showing what is the possibility. Why I believe in this, and so on and so forth. So that's one category.

Another category is it's basically trend. People wants to change their eyes. Some people asked me to do a different color of one eye, different from the other. By the way, I had one patient who asked me to do this, and it's not because of just trend. She said, my family, everybody has an heterochromia. I want to have the same thing. I had one patient who wants to go from blue to brown, which is exclusion from the rule.

Still majority of people, kind of like you know, it's a some type of external gratification to them. I think. They just need something to feel more comfortable. You don't know how many people told me told me that I changed their life. And it's not because I really changed their life. But because the eye is a mirror of the soul, kind of like they know, people look into the eye. And if you look on my IG, or just website, it doesn't matter if mine or not mine, you will see how much of a difference between, like five minutes before with the brown eyes and all of a sudden has become green or blue. They become kind of like different person. Not different inside. But to some degree, you know, it's like, it's really changing. And that's a lot of them changing. It's a life changing procedure.

And frankly, there were several people who I said, listen, I'm not going to do it for you. Because you're not ready, you're not going to be happy. And I cannot make you happy. And that's not my goal, to make you unhappy. So sorry, go home and think about it. I just, you know, give yourself time. There was 3 people who I took off from the table, because they were so unsure. I told them no you're not sure, just go sit down, think. If not come next time. If not next time just don't come at all.

I created the system, which allows me to remove about 50 to 60% of the pigment. So it's partially reversible. Also, you can substitute some other pigments, so it may change somewhat. If pupils are really unhappy with some blue, they won't make it a little bit greener. I can do it. But listen, everything has a limitation. I mean, if you have the sport car, and they will tell you listen, today we need to go and do some agricultural work very difficult, right? On a tractor, you cannot just compete on the speed, same thing.

It's something for something. You need to agree on certain things. And I need to agree from the medical standpoint, plus artistic. And they need to accept whatever I propose. So there is some risk, of course, but it's a measurable risk. It's a risk assumed by the patient and the doctor and you should act accordingly. And if you go with the rules, not against them, I don't see the big problem with this procedure.