Surgical method

The keratopigmentation technique involves creating a substantially narrow micro-tunnel in the thickness of the cornea using a Zeiss femtosecond laser (VisuMax 500/800). An experienced cornea fellowship-trained ophthalmologist with adequate training in this procedure uses this tunnel to introduce the pigments into the cornea.

BioChromaEyes ® pigments, which are manufactured by BIOTIC Phocea Laboratories in France, are used in this procedure. This company is the sole manufacturer of the pigments approved by ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé) and European health safety authorities.

Surgical technique

Keratopigmentation, or FLAAK, is performed in an outpatient setting, and there is no need for a hospital stay. Before the procedure, the patient’s eye is numbed by applying an anesthetic drop. Then, a micro-tunnel is created in the thickness of the cornea using the VisuMax femtosecond laser.

The cornea fellowship-trained ophthalmologist spreads the pigments into the micro-tunnel and dyes the cornea this way. It is worth noting that the surgeon’s proficiency is crucial to achieve a uniform and natural-looking color. Since this stage needs extra precision, it is usually time-consuming.

The entire operation for both eyes takes about 30-45 minutes and is performed in one session. Immediately post-operation, patients can see their eyes in the mirror and become aware of the operation results.

However, it takes several days to weeks for the final results to reach its final concentration and quality. Patients will be visited by the surgeon the day after the operation and given the follow-up instructions and the dates of follow-up examinations.

Under what conditions should keratopigmentation be performed?

The operation to permanently change eye color must be performed by a skilled cornea fellowship-trained ophthalmologist using the best-quality standard color in the world in a hospital with equipped operating rooms and advanced laser systems designed for this procedure.

Preoperative instructions

Adhering to preoperative instructions is necessary to ensure better outcomes from the keratopigmentation procedure. Some of them include:

  • If you use contact lenses, remove them eight days before the operation.
  • There is no need to be nil-by-mouth on the day of surgery. However, you should avoid heavy meals and only take a light meal before surgery.
  • Make sure to bring someone with you on the day of surgery.
  • Avoid wearing makeup from one week before surgery. Remove artificial eyelashes.
  • Avoid dusty places, contact with animals, horseback riding, and swimming from one week before surgery.
  • Avoid perfumes and sprays on the day of surgery.
  • Avoid wearing jewelry on the day of surgery.
  • Take a shower before the operation.
  • Do not bring your mobile phone with you to the operating room.

Preoperative examinations

Prior to the operation, the ophthalmologist examines the patient and requests a series of diagnostic and para-clinical tests. The imaging tests help the surgeon decide whether or not the patient is a suitable candidate for the keratopigmentation procedure. Moreover, these diagnostic measures are necessary to achieve better results. The common diagnostic tests before keratopigmentation are as follows:

  • Topography and pachymetry
  • Retinal OCT
  • corneal endothelial cell count
  • Anterior segment OCT if the patient has a history of refractive surgery like LASIK or SMILE.

Keratopigmentation procedure at a glance

Type of procedure: outpatient. This procedure does not need hospitalization and is performed in an outpatient setting.

Duration of procedure: 30-45 minutes for both eyes (in one session).

Type of anesthesia: This procedure is performed under local anesthesia using a numbing eye drop, and the patient feels no pain.

Surgical technique: Keratopigmentation method is applicable to most patients regardless of their natural eye color. It is performed in two steps:

  1. Creating a micro-tunnel in the corneal thickness using a femtosecond laser (VisuMax 500/800, Zeiss Company; it is the only femtosecond laser that allows for efficient laser keratopigmentation).
  2. Placing pigments into the micro-tunnel.

The cornea fellowship-trained ophthalmologist spreads the pigments into the micro-tunnel to color the cornea. The pigments must be distributed evenly and proficiently to achieve the most natural appearance possible.

Immediately after surgery: As soon as the patient leaves the operating room, they are given a mirror to see the operation results.

Postoperative follow-up: The first postoperative examination session is on the morning after surgery. The following examinations will be performed on the third day, first week, first month, and three months after surgery. After that, the examinations will become annual.

Keratopigmentation equipment

The equipment used in the keratopigmentation procedure is a VisuMax 500 or VisuMax 800 femtosecond laser manufactured by Zeiss Company. This laser system is the only one that is suitable for keratopigmentation operations.

Complications or issues during keratopigmentation procedure

The complications after keratopigmentation are less common and unpredictable. Some of the complications that may occur after this procedure include:

  • An incomplete corneal incision can alter the corneal shape or transparency and the distribution of pigments.
  • The pupil shape may subtly change. The location of laser placement may displace the micro-tunnel and give the impression of displaced or asymmetric pupil.
  • The distribution of pigments may be different between the two eyes and do not appear identical.

Final result

Although the eye color change is observable immediately after the operation, its intensity is not final, and the real result may be achieved after a few weeks. During this period, a portion of pigments are absorbed naturally, and the eye color becomes more natural over time.

Additional measures

In some cases, the intensity or color of the pigments may fade over time. This fading is natural and may be exacerbated by various factors, including exposure to sunlight without protective sunglasses. Thus, it may be necessary to perform a complementary procedure called touch-up to restore the original color. This procedure is usually performed three months after the initial surgery.

Complications of the keratopigmentation procedure

To achieve the desired outcome cannot be guaranteed in keratopigmentation as it depends on the healing process. Sometimes, treatment needs to be repeated a few months after the operation. A general rule is that “no surgery is completely safe,” and keratopigmentation is no exception. However, severe complications are rare; if complications arise, the intervention may need to be repeated. Even after resolving these complications, visual acuity may decrease, and in more severe cases, vision loss may occur. Yet assessing the frequency of such complications is impossible due to their extremely rare nature.

The complications of keratopigmentation may be as follows:

  • Infection: Although rare, keratopigmentation carries the risk of infection. A cycle of antibiotic treatment with hospital care is necessary to resolve infection.
  • Inflammation: A corneal inflammatory reaction might occur. Such an event is uncommon but can delay vision recovery. Treatment involves using cortisone eye drops. In rare cases, irrigation of the inflammation site in the operating room may be necessary.
  • Abnormal scarring: This complication is not common, but it can lead to corneal opacity and delayed visual recovery. The ophthalmologist may prescribe eye drops to resolve this condition. In certain cases, surgery may be required.
  • Corneal deformation or ectasia: This procedure may cause corneal ectasia which is a rare complication (1 in 700000 cases). The incidence of ectasia can be prevented with imaging and diagnostic measures (corneal topography) before the procedure.
  • Reduced visual acuity: A decrease in visual acuity has been reported in rare cases. It usually occurs secondary to other complications and depends on the surgeon’s skill, the type of color used, and the surgical technique.

Other less severe complications that may occur after keratopigmentation procedure are as follows:

  • Subconjunctival hemorrhage: This is a benign complication that may resolve within a few days without treatment.
  • Seeing halos around objects: This is common in the first weeks after the operation but is not irritating. Halos around light sources may disappear over time. Sometimes, seeing halos can persist and make driving at night difficult.
  • Eye dryness: Dry eye symptoms can be observed in 23% of surgical cases. However, the incidence rate of moderate to severe dryness is only 3%. There are several treatment options depending on the type of dryness, but most of the time, using moisturizing eye drops is sufficient. This complication is typically transient. In rare cases, visual recovery may be delayed by several months.
  • Glare: Light hypersensitivity is common in the first hours of the surgery, but it quickly resolves. Some patients may experience light sensitivity for a few days.
  • Night vision problems: The patient may experience poor vision at night or in low light.
  • Diplopia and blurred vision: This problem is uncommon and transient and is mostly caused by dry eyes after the operation.
  • Reduced uncorrected visual acuity: In rare cases, a slight change has been seen in visual problems before and after surgery that may require a prescription for glasses.
  • Fluctuations in vision clarity: This problem is common in the first days after surgery and resolves gradually as eye dryness continues to improve.

The safest method

Keratopigmentation seems the safest and most effective method of changing eye color. To date, thousands of people around the globe have undergone this operation without any serious complications. They have expressed satisfaction with operation results and experienced higher self-esteem in their lives. Compared to other techniques of changing eye color, keratopigmentation seems to be safer, with lower risk and more positive outcomes.

Please note that Noor Hospital does not recommend permanent eye color change solely for cosmetic reasons and encourages patients to use colored contact lenses. However, if we were to rank the methods for permanently changing eye color according to their safety, keratopigmentation undoubtedly would be at the top of the list. If the candidates are determined to change their eye color in this way, we are ready to perform this procedure with a detailed explanation, adhering to best care practices and using state-of-the-art techniques and technologies.

Final remarks

  • Be ready for the reactions of others, as keratopigmentation is more surprising than the hair color change or haircut.
  • Through consultations with the ophthalmologist or reading the provided education pamphlets, you will learn that it may take several weeks to months to accept a new look in your life.
  • While pigments are injected as evenly and close to the selected design as possible, keep in mind that achieving the initial design is not guaranteed, and it is not possible to reproduce exactly the same look. However, the final result will be quite similar to the initial design.
  • Perquisites regarding the visual capabilities of individuals in various professions are revised constantly. Thus, it is necessary to check the respective rules in your organization and see whether keratopigmentation is acceptable in the job and organization that you are working in (such as police and military forces, fire stations, and road, air or rail transport services).
  • Note: Since keratopigmentation leads to a change in physical look, updating identity documents may be mandatory.
  • Keratopigmentation results are not essentially permanent or final. Sometimes, pigments can fade over time and lose their brightness, color, or intensity. In case of incomplete results, sometimes a second operation on the patient’s eye may be necessary to restore the desired color. This second operation is called “touch-up.”
  • This technique is not fully reversible. It is possible to remove some pigments, but not all of them. If patients decide to change back to their original eye color, using a pigment similar to their natural eye color can help partially restore the previous state, but the results will not be exactly the same.
  • Regardless of the initial visual defect, this operation can alter visual acuity. In some cases, particularly presbyopia, it may be necessary to change the prescription of the glasses or receive new glasses after keratopigmentation. If needed, refractive surgeries must be performed at least four months after keratopigmentation.
  • The aesthetic effect of keratopigmentation is comparable to cosmetic contact lenses. Depending on pupil size, the central part of the iris may be seen in its original color at a close distance. But at a normal distance, it blends with pupil blankness and is not visible or significant.

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