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Cosmetic surgery of the cornea: A new type of surgery

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Over the past 10 years, an increasing number of studies have been conducted on the topic of keratopigmentation, that is, the induced cosmetic pigmentation change in the cornea.

This cosmetic change can be done for therapeutic purposes (eg, for corneal leukomas and blind and disfigured eyes, as well as cases with traumatic aniridia or other problems that affect the eye’s quality of vision).

The topic has been extensively studied and covered in a series of papers that have demonstrated that such techniques are effective, feasible, and very useful for patients.1-16

Following this, the purely cosmetic application of this technique has offered the possibility to change the apparent color of the eye on a voluntary basis. This is purely an aesthetic application that has been obviously disruptive and controversial. My colleagues and I first described this technique,7 and it has been practiced in Europe by a few surgeons on a continual but selective basis. The biotolerance and local toxicity of the pigments used in keratopigmentation have been the subject of extensive experimental studies.2,6,8 In Figure 1, we display the instruments used in the modern keratopigmentation surgical technique.

FIGURE 1. Instruments Used in Keratopigmentation

FIGURE 2. Femtosecond-Assisted Intrastromal Keratopigmentation

FIGURE 3. Superficial Keratopigmentation (Images courtesy of Jorge L. Alió, MD, PhD, FEBOphth)

Therapeutic keratopigmentation is indeed a new and relevant type of corneal surgery; however, it is still not in general use, essentially because of the insufficient development of pigments specifically for corneal use. Patients with disfigured corneas and blind eyes, and patients who prefer not to go through the trauma associated with evisceration and enucleation and their potential complications, find this new type of surgery can prove to be a very valuable alternative that can successfully restore their appearance in a less invasive manner.1,10

The pigment may be placed inside the corneal stroma when the superficial cornea is transparent (intrastromal keratopigmentation); (Figure 2). With totally opaque corneas, the technique should be performed by applying the pigment on the corneal surface (superficialkeratopigmentation)9,11; (Figure 3), either manually or using an automatic device (Figure 4). In superficial keratopigmentation, the pigment is injected into the superficial corneal stroma up to the level of 140 mm, after denuding the corneal epithelium (Figure 3).

Superficial leucomas are treated with superficial techniques, whereas deep opacities, aniridias, and other problems that happen in a patient’s eye are better treated by intralamellar techniques.4,5 Surgical instruments and techniques have also been described in detail in other publications.15 (Figures 1 and 4).

When the superficial corneal stroma is transparent, the intrastromal pigmentation technique can be better used. For this purpose, corneal stromal tunnels are created, assisted by femtosecond laser at the adequate corneal depth,4,5 which also creates a dissection to simulate the pupil at an adequate diameter (Figure 2).

FIGURE 4. Superficial Automated Keratopigmentation Device

Such corneal tunnels may also be created manually using adequately designed instruments (Figures 1 and 2).

The pigment is matched to the color of the contralateral normal eye, whereas the pupil is simulated with black pigment (Figure 5).

The main limitation of this technique is the availability of pigments, which are, as of the writing of this article, limited to a few colors and labeled for corneal use with the CE mark. The use of dermatological pigments probably could be acceptable, but the lack of negative effects has not yet been demonstrated on the normal or diseased cornea, as the pigments are made of compounds that are often reactive when in contact with light; thus, oxidation may occur. This can lead to a change in the color over time and might make outcomes of this surgery unpredictable.

Frequently, severely compromised and blind eyes are associated with other disfiguring features such as squint and ptosis, which can also be successfully corrected at the same time as the keratopigmentation procedure is performed. A high level of patient satisfaction has been reported with the use of such combined surgical techniques12 (Figure 6).

FIGURE 5. Manual Intrastromal Keratopigmentation and Pupil Simulation With Superficial Automated Keratopigmentation. Total corneal leucoma (left) and result after treatment with femtosecond- assisted intrastromal keratopigmentation and superficial automated keratopigmentation for the pupil (right).

FIGURE 6. Keratopigmentation With Strabismus Surgery. Preoperative appearance before keratopigmentation and squint surgery (top) and postoperative result (right). (Images courtesy of Jorge L. Alió, MD, PhD, FEBOphth)

Functional disabilities are caused by iris problems such as aniridia, iris atrophy and iris colobomas.3-5 Some of these cases, whichither have no solution or require extensive and invasive surgeries, may be approached today with intrastromal keratopigmentation. Even intractable diplopias can be solved with keratopigmentation creating a central scotoma through the creation of a simulated pupil of adequate diameter.15,16

Controversial topic

The purely cosmetic use of keratopigmentation is disruptive and controversial because of the voluntary change of color of the eye that intrinsically has this problem. The procedure is elective, can be performed inadequately, and can lead to complications in normal eyes. With respect to this fact, findings from a recent study13 demonstrated that keratopigmentation is, undoubtedly, the best option available for those individuals who wish to change the apparent color of the eye on a voluntary basis. It demonstrates superior safety to and better outcomes than the alternative approaches using iris color prosthesis or laser iris depigmentation procedures, which are affected by myriad severe complications that can lead to severe visual loss and even blindness.14 In particular, the use of prosthetic colored irises should be considered today as a medical malpractice procedure because of the proven severe comorbidities that have been demonstrated to be induced by their implantation in the medium and long terms.

Emerging surgical technique

With this in mind, it should be considered that this emerging surgical technique of keratopigmentation has been refined with the modern development of specific surgical instruments. These include femtosecond lasers and the modern development of pigments. However, the corneal pigments used are considered underdeveloped owing to the main limitation of this technique to be used in general.

Thus, this technique is open to future developments that will be extremely attractive for ophthalmologists, corneal specialists, and cosmetic surgeons. It will also be attractive for patients affected by morbidities that affect the cosmetics of their eyes due to disfiguring corneal leukomas. The procedure will also appeal to patients who desire to change their appearance through the color of their eyes, which should be done for good reason and with appropriate selection by their surgeons.

A new corneal surgical perspective is now available with a good level of published evidence in support. I envision a promising future that will follow this group of new surgical techniques. This topic will probably progress immensely in the coming years along with the increase in clinician experience and the development of more appropriate, specific, and diverse corneal pigments.

Jorge L. Alió, MD, PhD, FEBOphth
E: jlalio@vissum.com
Alió is professor and chairman of ophthalmology at Miguel Hernández University, and founder of Vissum Miranza in Alicante, Spain.
References:
1. Alio JL, Sirerol B, Walewska-Szafran A, Miranda M. Corneal tattooing (keratopigmentation) with new mineral micronised pigments to restore cosmetic appearance in severely impaired eyes. Br J Ophthalmol. 2010;94(2):245-249. doi:10.1136/bjo.2008.149435
2. Sirerol B, Walewska-Szafran A, Alio JL, Klonowski P, Rodriguez AE. Tolerance and biocompatibility of micronized black pigment for keratopigmentation simulated pupil reconstruction. Cornea. 2011;30(3):344-350. doi:10.1097/ICO.0b013e3181eae251
3. Alio JL, Rodriguez AE, Toffaha BT. Keratopigmentation (corneal tattooing) for the management of visual disabilities of the eye related to iris defects. Br J Ophthalmol. 2011;95(10):1397-1401. doi:10.1136/bjophthalmol-2011-300170
4. Alió JL, Rodriguez AE, Toffaha BT, Piñero DP, Moreno LJ. Femtosecond-assisted keratopigmentation for functional and cosmetic restoration in essential iris atrophy. J Cataract Refract Surg. 2011;37(10):1744-1747. doi:10.1016/j.jcrs.2011.08.003
5. Alio JL, Rodriguez AE, Toffaha BT, El Aswad A. Femtosecond-assisted keratopigmentation double tunnel technique in the management of a case of Urrets-Zavalia syndrome. Cornea. 2012;31(9):1071-1074. doi:10.1097/ICO.0b013e318243f6b1
6. Amesty MA, Alio JL, Rodriguez AE. Corneal tolerance to micronised mineral pigments for keratopigmentation. Br J Ophthalmol. 2014;98(12):1756-1760. doi:10.1136/bjophthalmol-2014-305611
7. Alió JL, Rodriguez AE, El Bahrawy M, Angelov A, Zein G. Keratopigmentation to change the apparent color of the human eye: a novel indication for corneal tattooing. Cornea. 2016;35(4):431-437. doi:10.1097/ICO.0000000000000745
8. Amesty MA, Rodriguez AE, Hernández E, De Miguel MP, Alio JL. Tolerance of micronized mineral pigments for intrastromal keratopigmentation: a histopathology and immunopathology experimental study. Cornea. 2016;35(9):1199-1205. doi:10.1097/ICO.0000000000000900
9. Rodriguez AE, Amesty MA, El Bahrawy M, Rey S, Alio Del Barrio J, Alio JL. Superficial automated keratopigmentation for iris and pupil simulation using micronized mineral pigments and a new puncturing device: experimental study. Cornea. 2017;36(9):1069-1075. doi:10.1097/ICO.0000000000001249
10. Alio JL, Al-Shymali O, Amesty MA, Rodriguez AE. Keratopigmentation with micronised mineral pigments: complications and outcomes in a series of 234 eyes. Br J Ophthalmol. 2018;102(6):742-747. doi:10.1136/bjophthalmol-2017-310591
11. Al-Shymali O, Rodriguez AE, Amesty MA, Alio JL. Superficial keratopigmentation: an alternative solution for patients with cosmetically or functionally impaired eyes. Cornea. 2019;38(1):54-61. doi:10.1097/ICO.0000000000001753
12. Balgos JD, Amesty MA, Rodriguez AE, Al-Shymali O, Abumustafa S, Alio JL. Keratopigmentation combined with strabismus surgery to restore cosmesis in eyes with disabling corneal scarring and squint. Br J Ophthalmol. 2020;104(6):785-789. doi:10.1136/bjophthalmol-2019-314539
13. D’Oria F, Alio JL, Rodriguez AE, Amesty MA, Abu-Mustafa SK. Cosmetic keratopigmentation in sighted eyes: medium- and long-term clinical evaluation. Cornea. 2021;40(3):327-333. doi:10.1097/ICO.0000000000002417
14. D’Oria F, Abu-Mustafa SK, Alio JL. Cosmetic change of the apparent color of the eye: a review on surgical alternatives, outcomes and complications. Ophthalmol Ther. 2022;11(2):465-477. doi:10.1007/s40123-022-00458-2
15. Alio JL, Amesty MA, Rodriguez A, El Bahrawy M, eds. Text and Atlas on Corneal Pigmentation. 1st ed. Jaypee Brothers Medical Publishers (P) Ltd; 2015.
16. Laria C, Alió JL, Piñero DN. Intrastromal corneal tattooing as treatment in a case of intractable strabismic diplopia (double binocular vision). Binocul Vis Strabismus Q. 2010;25(4):238-242.

 

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Health Canada approves updated Moderna COVID-19 vaccine

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TORONTO – Health Canada has authorized Moderna’s updated COVID-19 vaccine that protects against currently circulating variants of the virus.

The mRNA vaccine, called Spikevax, has been reformulated to target the KP.2 subvariant of Omicron.

It will replace the previous version of the vaccine that was released a year ago, which targeted the XBB.1.5 subvariant of Omicron.

Health Canada recently asked provinces and territories to get rid of their older COVID-19 vaccines to ensure the most current vaccine will be used during this fall’s respiratory virus season.

Health Canada is also reviewing two other updated COVID-19 vaccines but has not yet authorized them.

They are Pfizer’s Comirnaty, which is also an mRNA vaccine, as well as Novavax’s protein-based vaccine.

This report by The Canadian Press was first published Sept. 17, 2024.

Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.

The Canadian Press. All rights reserved.

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These people say they got listeria after drinking recalled plant-based milks

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TORONTO – Sanniah Jabeen holds a sonogram of the unborn baby she lost after contracting listeria last December. Beneath, it says “love at first sight.”

Jabeen says she believes she and her baby were poisoned by a listeria outbreak linked to some plant-based milks and wants answers. An investigation continues into the recall declared July 8 of several Silk and Great Value plant-based beverages.

“I don’t even have the words. I’m still processing that,” Jabeen says of her loss. She was 18 weeks pregnant when she went into preterm labour.

The first infection linked to the recall was traced back to August 2023. One year later on Aug. 12, 2024, the Public Health Agency of Canada said three people had died and 20 were infected.

The number of cases is likely much higher, says Lawrence Goodridge, Canada Research Chair in foodborne pathogen dynamics at the University of Guelph: “For every person known, generally speaking, there’s typically 20 to 25 or maybe 30 people that are unknown.”

The case count has remained unchanged over the last month, but the Public Health Agency of Canada says it won’t declare the outbreak over until early October because of listeria’s 70-day incubation period and the reporting delays that accompany it.

Danone Canada’s head of communications said in an email Wednesday that the company is still investigating the “root cause” of the outbreak, which has been linked to a production line at a Pickering, Ont., packaging facility.

Pregnant people, adults over 60, and those with weakened immune systems are most at risk of becoming sick with severe listeriosis. If the infection spreads to an unborn baby, Health Canada says it can cause miscarriage, stillbirth, premature birth or life-threatening illness in a newborn.

The Canadian Press spoke to 10 people, from the parents of a toddler to an 89-year-old senior, who say they became sick with listeria after drinking from cartons of plant-based milk stamped with the recalled product code. Here’s a look at some of their experiences.

Sanniah Jabeen, 32, Toronto

Jabeen says she regularly drank Silk oat and almond milk in smoothies while pregnant, and began vomiting seven times a day and shivering at night in December 2023. She had “the worst headache of (her) life” when she went to the emergency room on Dec. 15.

“I just wasn’t functioning like a normal human being,” Jabeen says.

Told she was dehydrated, Jabeen was given fluids and a blood test and sent home. Four days later, she returned to hospital.

“They told me that since you’re 18 weeks, there’s nothing you can do to save your baby,” says Jabeen, who moved to Toronto from Pakistan five years ago.

Jabeen later learned she had listeriosis and an autopsy revealed her baby was infected, too.

“It broke my heart to read that report because I was just imagining my baby drinking poisoned amniotic fluid inside of me. The womb is a place where your baby is supposed to be the safest,” Jabeen said.

Jabeen’s case is likely not included in PHAC’s count. Jabeen says she was called by Health Canada and asked what dairy and fresh produce she ate – foods more commonly associated with listeria – but not asked about plant-based beverages.

She’s pregnant again, and is due in several months. At first, she was scared to eat, not knowing what caused the infection during her last pregnancy.

“Ever since I learned about the almond, oat milk situation, I’ve been feeling a bit better knowing that it wasn’t something that I did. It was something else that caused it. It wasn’t my fault,” Jabeen said.

She’s since joined a proposed class action lawsuit launched by LPC Avocates against the manufacturers and sellers of Silk and Great Value plant-based beverages. The lawsuit has not yet been certified by a judge.

Natalie Grant and her seven year-old daughter, Bowmanville, Ont.

Natalie Grant says she was in a hospital waiting room when she saw a television news report about the recall. She wondered if the dark chocolate almond milk her daughter drank daily was contaminated.

She had brought the girl to hospital because she was vomiting every half hour, constantly on the toilet with diarrhea, and had severe pain in her abdomen.

“I’m definitely thinking that this is a pretty solid chance that she’s got listeria at this point because I knew she had all the symptoms,” Grant says of seeing the news report.

Once her daughter could hold fluids, they went home and Grant cross-checked the recalled product code – 7825 – with the one on her carton. They matched.

“I called the emerg and I said I’m pretty confident she’s been exposed,” Grant said. She was told to return to the hospital if her daughter’s symptoms worsened. An hour and a half later, her fever spiked, the vomiting returned, her face flushed and her energy plummeted.

Grant says they were sent to a hospital in Ajax, Ont. and stayed two weeks while her daughter received antibiotics four times a day until she was discharged July 23.

“Knowing that my little one was just so affected and how it affected us as a family alone, there’s a bitterness left behind,” Grant said. She’s also joined the proposed class action.

Thelma Feldman, 89, Toronto

Thelma Feldman says she regularly taught yoga to friends in her condo building before getting sickened by listeria on July 2. Now, she has a walker and her body aches. She has headaches and digestive problems.

“I’m kind of depressed,” she says.

“It’s caused me a lot of physical and emotional pain.”

Much of the early days of her illness are a blur. She knows she boarded an ambulance with profuse diarrhea on July 2 and spent five days at North York General Hospital. Afterwards, she remembers Health Canada officials entering her apartment and removing Silk almond milk from her fridge, and volunteers from a community organization giving her sponge baths.

“At my age, 89, I’m not a kid anymore and healing takes longer,” Feldman says.

“I don’t even feel like being with people. I just sit at home.”

Jasmine Jiles and three-year-old Max, Kahnawake Mohawk Territory, Que.

Jasmine Jiles says her three-year-old son Max came down with flu-like symptoms and cradled his ears in what she interpreted as a sign of pain, like the one pounding in her own head, around early July.

When Jiles heard about the recall soon after, she called Danone Canada, the plant-based milk manufacturer, to find out if their Silk coconut milk was in the contaminated batch. It was, she says.

“My son is very small, he’s very young, so I asked what we do in terms of overall monitoring and she said someone from the company would get in touch within 24 to 48 hours,” Jiles says from a First Nations reserve near Montreal.

“I never got a call back. I never got an email”

At home, her son’s fever broke after three days, but gas pains stuck with him, she says. It took a couple weeks for him to get back to normal.

“In hindsight, I should have taken him (to the hospital) but we just tried to see if we could nurse him at home because wait times are pretty extreme,” Jiles says, “and I don’t have child care at the moment.”

Joseph Desmond, 50, Sydney, N.S.

Joseph Desmond says he suffered a seizure and fell off his sofa on July 9. He went to the emergency room, where they ran an electroencephalogram (EEG) test, and then returned home. Within hours, he had a second seizure and went back to hospital.

His third seizure happened the next morning while walking to the nurse’s station.

In severe cases of listeriosis, bacteria can spread to the central nervous system and cause seizures, according to Health Canada.

“The last two months have really been a nightmare,” says Desmond, who has joined the proposed lawsuit.

When he returned home from the hospital, his daughter took a carton of Silk dark chocolate almond milk out of the fridge and asked if he had heard about the recall. By that point, Desmond says he was on his second two-litre carton after finishing the first in June.

“It was pretty scary. Terrifying. I honestly thought I was going to die.”

Cheryl McCombe, 63, Haliburton, Ont.

The morning after suffering a second episode of vomiting, feverish sweats and diarrhea in the middle of the night in early July, Cheryl McCombe scrolled through the news on her phone and came across the recall.

A few years earlier, McCombe says she started drinking plant-based milks because it seemed like a healthier choice to splash in her morning coffee. On June 30, she bought two cartons of Silk cashew almond milk.

“It was on the (recall) list. I thought, ‘Oh my God, I got listeria,’” McCombe says. She called her doctor’s office and visited an urgent care clinic hoping to get tested and confirm her suspicion, but she says, “I was basically shut down at the door.”

Public Health Ontario does not recommend listeria testing for infected individuals with mild symptoms unless they are at risk of developing severe illness, such as people who are immunocompromised, elderly, pregnant or newborn.

“No wonder they couldn’t connect the dots,” she adds, referencing that it took close to a year for public health officials to find the source of the outbreak.

“I am a woman in my 60s and sometimes these signs are of, you know, when you’re vomiting and things like that, it can be a sign in women of a bigger issue,” McCombe says. She was seeking confirmation that wasn’t the case.

Disappointed, with her stomach still feeling off, she says she decided to boost her gut health with probiotics. After a couple weeks she started to feel like herself.

But since then, McCombe says, “I’m back on Kawartha Dairy cream in my coffee.”

This report by The Canadian Press was first published Sept. 16, 2024.

Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.

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B.C. mayors seek ‘immediate action’ from federal government on mental health crisis

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VANCOUVER – Mayors and other leaders from several British Columbia communities say the provincial and federal governments need to take “immediate action” to tackle mental health and public safety issues that have reached crisis levels.

Vancouver Mayor Ken Sim says it’s become “abundantly clear” that mental health and addiction issues and public safety have caused crises that are “gripping” Vancouver, and he and other politicians, First Nations leaders and law enforcement officials are pleading for federal and provincial help.

In a letter to Prime Minister Justin Trudeau and Premier David Eby, mayors say there are “three critical fronts” that require action including “mandatory care” for people with severe mental health and addiction issues.

The letter says senior governments also need to bring in “meaningful bail reform” for repeat offenders, and the federal government must improve policing at Metro Vancouver ports to stop illicit drugs from coming in and stolen vehicles from being exported.

Sim says the “current system” has failed British Columbians, and the number of people dealing with severe mental health and addiction issues due to lack of proper care has “reached a critical point.”

Vancouver Police Chief Adam Palmer says repeat violent offenders are too often released on bail due to a “revolving door of justice,” and a new approach is needed to deal with mentally ill people who “pose a serious and immediate danger to themselves and others.”

This report by The Canadian Press was first published Sept. 16, 2024

The Canadian Press. All rights reserved.

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