Femtosecond laser-assisted annualr keratopigmentation to change eye color: common questions.
Prepared by prof dr Osama Al Nahrawy.
Is this technique allowed from the religious point of view?
Yes, please read fatwa dar El Eftaa, (it is attached to our web site), the Egyptian Relegious authority which confirms that this procedure is allowed and is not considered a change of what Allah had created. This is the link to read the fatwa: https://www.dar-alifta.org/ar/fatawa/12570/زرع-العدسات-الملونة
What is the type of laser used?
The femtosecond laser (the Egyptian Researcher Chemist Ahmad Zowail, , in California, USA, who got the Noble Prize in 1999).
Since how long does this technique exist? And in which countries?
This technique started in Spain, 15 years ago (Prof dr Jorge Alio, Alicante), then in France (Prof dr Francis Ferrari), then in United states of America (Prof Dr. Movshovich, New York and New Jersey). The technique is available in many countries now, including EGYPT. It is propagating to many other countries. This is as far as we know.
Details and How much time does this technique take in the operation room?
The technique is composed of two parts: the first part inside the room of the femtosecond laser, where the laser is being used to create an annular pocket or tunnel in the mid-periphery of the cornea. This pocket will be used to contain the coloring pigment. The second part of surgery is to place the pigment using a surgical microscope inside the operation room.
What is the source and composition of the coloring pigment?
The pigment is obtained from the French company, Biotic Fochea, in Mersilia, and from the French center, Neoris, in Paris. This pigment is made from micronized mineral pigments and is under the licensing and supervision of the French Government and authorities and the European Union regulations. The pigment is biocompatible and safe. There are different pigments for different colors.
Is it stable over years?
The intensity of some colors may change with time, to some degree (fading). Placing an additional amount of color could be done safely and easily.
What about the anaethesia used?
Anesthesia drops is used. For some people who are very sensitive the anesthesia doctor may give them a sedating medicine inside the vein.
What happens if a person is not satisfied with the color? Or if he desires a special color that is not shown on the galleries ?
The technique is not reversible, so people are advised to think seriously and decide. Additional color could be placed again and its intensity could be revised. For a special color request, we consult the French manufacturing company. They have a research department and will look to the request, then give advice. Mixing colors with percentages will give new colors. People can enjoy their preferred nice and beautiful eye colors.
What are the side effects during the recovery after surgery?
People experience some foggy vision for one or two days. This improves rapidly. They may have some eye pain. Using drops and analgesics will overcome this little eye pain.
Can I drive immediately after surgery? Can I come alone?
No, you can’t drive in the same day. It is better to have a company. If not available, order an Uber taxi.
If a person had lasik or femtolasik surgery before, is he allowed to have this technique?
Yes, he is allowed. The previous femtolasik flap is adherent to the cornea at its edge, but poorly adherent at the center. The possibility of dislocation is very rare since the applied force by the femtolaser docking is perpendicular (tangential forces, at 45 degrees, to the cornea, might cause a flap dislocation). The femtolaser annular pocket is usually located deeper than the flap depth and is present peripheral, from 5.5 to 9.5 mm. Usually the depth is at 250-350 microns from the surface. The pocket is away from the central visual area of the cornea. The mid-peripheral and peripheral cornea is thicker than the central part. Most probably, the pocket will not affect the corneal biomechanics. This is a good research point. However, it is preferable that people choose the surface ablation techniques to correct their vision and to avoid cutting flaps, especially if they intend to have cosmetic keratopigmentation technique.
If a person has a poor vision, and wants to have this technique, what is the advice?
I advise having keratopigmentaion first, then few months later, have the surface ablation technique to correct vision. Also, people may have surface ablation techniques to correct vision then three months later, have the keratopigmentation.
If a person has bilateral cataract (lens opacity), and wants to have this technique, what is the proper plane?
The annular femtolaser pocket is done first, then, in the same day Cataract surgery should be done for one eye, next day for the other eye. 3-4 days later, the pigment could be placed inside the pocket. Ten days to 2 weeks duration will be enough to manage bilateral cataract and perform keratopigmentation.
If a person develops cataract, with aging, in the coming years, after this technique, will this annular pocket and the contained coloring pigment, affect the ability of the surgeon to perform the surgery?
No. The area of 5.0-5.5 mm of central clear cornea, will be enough for successful cataract surgery and having an intra ocular access.
What about the cost of this surgery ? Could there be installments ?
People should make a search about costs of this surgery to know the average. There may be some variability from a person to a person and from country to country. People should contact the administration and attend for a consultation. Some local companies could arrange and help for monthly installments.
Is this technique safe? And is it useful for mental and physical health?
Yes, it is safe (based on my experience and the experiences of all international centers and eminent eye professors and surgeons, over 15 years on thousands of people who had the procedure). It is even safer than lasik.
People enjoy better eye color which is the most important part of body image. This is important for both mental and physical health (according to the report of House of Commons: The impact of Body Image on Mental and Physical Health, UK, 2023-23).
The technique does not affect the vision, or the eye pressure. It does not affect the interior of the eye, like retina and optic nerve. We routinely perform electronic eye investigations and testing before and after the surgery (pentacam, specular endothelial cell counts, OCT macula and optic nerve). Those tests prove safety of all eye parts and layers. After the surgery (when guests come and perform them), the results are the same before and after. Even after a long time. This is a good point of research.
From NEORIS-EYES (France, we quote this for you):
How can I change the color of my eyes?
Change the color of your eyes: who hasn’t dreamed of it? There are temporary methods to change the color of your eyes, such as wearing colored lenses or makeup tricks to enhance the color of your eyes, but the most durable and accurate method to change the color of your eyes is aesthetic annular keratopigmentation. This method is safe, reliable and fast! In just one hour, you can have the eye color you’ve always wanted. You will no longer need to remove your colored lenses every day or feel the discomfort of wearing them, and you won’t risk getting a corneal infection from the lenses.
What your eye color says about you?
“The deep blue of the ocean, the intense and precious green of an emerald, the warm and radiant golden honey, and the white to lighten your natural color”. People with brown or brown eyes are said to be friendly, loyal and trustworthy. People with green eyes are seductive, enterprising and mysterious, and people with hazel eyes are adventurous, independent and confident. And people with blue eyes are said to be very intelligent, generous and wise. “The eyes are the mirror of the soul”. Our eyes convey strong emotions and their color says a lot about our personality. With Neoris keratopigmentation, you can finally change the color of your original eyes for blue, green or brown. You can also opt to lighten your natural color with white pigment
Changing your eye color: aesthetics and well-being?
Changing your eye color can improve your self-confidence, make you feel better about your body, and can help some people accept themselves and heal deep wounds. For example, some people are born with brown eyes, but everyone else in their family has blue eyes. This can make a person feel very different because they feel that they weren’t born with the same physical traits as the rest of their family.
Laser iris melanin Depigmentation to lighten or modify the eye color
Common questions and answers, based on my practice and experience
Prepared by dr Osama Al Nahrawy, Cairo, EGYPT.
Is this procedure a surgical one? What about it ?
No. It is an outpatient clinic procedure. It is composed of having many sessions (5-12 sessions) over many visits. Two or more sessions in a week could be done. The number of these visits varies from person to person, according to the heaviness of iris melanin and how dark is the eye color. People who have darker iris color need bigger number of sessions. A face to face consultation, in my office, at Cairo, is necessary to design a suitable protocol for every guest.
Is it a malpractice ? what about FDA approval ?
No, it is not a malpractice. It is an off-label procedure. This means using an approved laser for doing a non-approved procedure. All medical procedures start like this. Later they are approved when proved to be safe and when studies are submitted to the FDA in the USA. Medical procedures outside USA, may have some difficulty and some delay in obtaining approval. Example of this is the Zeiss femtosecond laser platform Visumax. It was used as an off-label procedures in Germany itself, in UK, France, Italy, Middle East, and all countries except USA, for 10 years. It got FDA approval at 2016 only, since then it is being used in USA. The American Academy of Ophthalmology recognizes a lot of non-approved medical products, intraocular lenses, and procedures, as mentioned in its series of publications. There are many safe medical procedures which did not get the FDA approval. There are many medicines and procedures which got FDA approval, but later were proved to have high risks and were withdrawn and called from markets (like Cachet lens of Alcon, USA, Morcher IOL, etc). There are many safe medicines, who are safe and are being used even did not get the FDA approval (like Bevacizumab (Avastin). It is expected that with time, this cosmetic procedure would be FDA approved.
Is the procedure safe ?
Yes. It is safe. It is spreading and propagating into many countries and centers. Thousands of people have the procedure and are safe. There are criteria for inclusion and exclusion. During my practice for the procedure, vision, refraction, and eye pressure are being measured before and after. They stay normal. Electronic investigations (pentacam, specular corneal endothelial cell counts, Optical Coherence Tomography (OCT) optic nerve and macula are being done before and after sessions, and they stay within normal. This recorded clinical data confirm safety. Risky, non safe procedures can’t stay, can’t grow and propagate.
What about this laser and how deos it work ?
It is a nonvisible Nd-Yag laser, 1064 nanometer wavelength. When it is incident on the iris anterior surface, melanin pigment absorbs the laser and a shock wave disrupts the melanin under the point of incidence and on the sides of the shock wave. Repeated shots and repeated shock waves, over many points, causes depigmentation and color lightening and change. The released debris is being absorbed from the anterior chamber into the iris vascular system through plasmalemmal vesicles. The pathway is called unconventional uveo-vortex pathway. Experimental studies found that Fluoroscein tracer, when injected into the anterior chamber of Rhesus Monkeys, were traced to the vortex veins then to the systemic circulation. My observations show that the debris disappears within two hours.
Are there any inflammation after sessions ?
No, there are no inflammatory reactions, no KPs, No aquous flare, no hypopyon. This is explained by the immune privilege of the eye and anterior chamber associated immune deviation (ACAID).
Who should be excluded ?
People who have the following criteria: any eye disease: sever dry eye, corneal opacities, cataract, glaucoma, diabetic retinal complications, etc. People who have non-realistic expectations, unstable personalities, or psychiatric disorders.
Can people notice immediate lightening or eye color change after one session ?
Good responders can notice lightening and significant change after the first sessions. A good external or natural light is needed to show the response. Average and poor responder people may not notice a change after one session. People are advised to be patient and not to be in a hurry. With this technique, we can’t promise people of having a specific result. The final results depends on many factors, like the amount of melanin on the anterior surface of the iris, the amount of melanin inside the stroma of the iris, the type of melanin if it is eumelanin (the black molecules) or the pheomelanin (the red or yellow molecules). Also, the background of the iris collagen and its tinge of color. There are people who gave a greenish tinge or bluish tinge of collagen, which produces greenish or bluish colors after finishing the sessions and removing the surface melanin.
What do people feel after a session ?
People feel some degree of fogginess of vision, but they still can see and can use the mobile phones. There are some watering and sometimes little eye pain. Those symptoms, if present are transient.
What is a usual treatment to be described after a session and for how long ?
Two or three types of drops are being used. A non-steroidal anti-inflammtory, a drop to lower the eye pressure (although it stays at a normal level), and a lubricant drop to sooth eye surface. May be an analgesic pain killer is added if there is a little pain.
What about the response of Depigmentation ?
Different people have different responses to sessions. At the beginning and during consultation at the office, I make medical high quality external eye photography. This is useful to decide which grade of color are your eyes. Grades of color range from 1-6, where grade 1 is the blue irides, without melanin pigment over the collagen fibers, and grad 6 is the most dense melanin pigmentation and where eyes appear darkly brown and black. Those grades from 5-6, better not to have depigmentation as they are expected to be poor responders and they will need large number of sessions over two rounds. After removing the melanin layer, there is another melanin molecules inside the iris stroma which is a reason for residual dark color and residual dissatisfaction. There are people who are moderate or average responders and people who are excellent responders. It is noticed that the background collagen stroma may have a color tinge that controls the final color. The melanin inside the stroma, may be of the eumelanin type where the molecules are black and bark brown, or could be of the pheomelanin type, where the melanin molecules are red or yellow and the background color could be hazel or greenish or bluish. We cannot control obtaining these beautiful results.
There are people who have hazel eyes, where an amount of brown melanin exists over a greenish stroma. Once this brown melanin is removed, with little number of sessions, the green color appears very nicely. Those are a group of best responders.
If a person has a poor vision and asks for laser vision correction , what is the advise ?
Laser vision correction could be done either before or after depigmentation sessions. Better to be done after sessions. Better to have surface ablation, no flap lifting.
If a person is partially satisfied with the color change after some sessions, can he go for another technique like Femtosecond laser-assisted keratopigmentation ?
Yes, at any time, a person can convert into coloration of the cornea with the French pigment. Sometimes, the lightening which happened for the iris, helps obtaining nicer color after keratopigmentation (additive effect).
What are the possible complications ?
Few transient non-vision threatening complications may take place. Examples are: during the sessions, dot iris hemorrhages, which stop soon and disappear within 1-2 days. Foggy vision for few hours due to the liberated melanin dust and debris. This disappears withn few hours. Light sensitivity which is overcome by sunglasses and disappears within few days if happens. A possible elevation of the eye pressure, which is transient and disappears within few days if happens. May be over a long term, it is a risk factor to eye pressure elevation as some debreis and melanin pigment may go the trabecular meshwork of the angle of the anterior chamber. The follow up of most people over years shows that they are safe.
