Safety and efficacy of a new ring keratopigmentation: a case study

Summary

Background:

We studied the safety and efficacy of a new aesthetic technique of femtosecond-assisted ring keratopigmentation.

Case study:

A 21 year old patient in good general and ophthalmic health, who wanted to change the color of her eyes. She was treated with a femtosecond-assisted annular keratopigmentation technique. The pigment was inserted into a corneal channel (outer diameter 9.3 mm; inner diameter 5.5 mm)
created with a femtosecond laser at a depth of 225 μm. Eight months after the operation, there were no
Eight months after the operation, there was no evidence of leakage, diffusion, inflammation or any other adverse effect on the cornea, both objectively and subjectively.

Conclusion:

This procedure is a promising, safe and effective option for those who desire ring keratopigmentation for aesthetic reasons.

Introduction

Corneal tattooing has been used for a long time and was first mentioned by Galen in the 1st century. These techniques are mainly used for therapeutic purposes in patients with iris defects, corneal scarring, leukocoria, strabismus diplopia and Urrets-Zavalia syndrome. Improved surgical techniques and dyes used have led to a growing interest in corneal examination and corneal tattooing for cosmetic purposes in recent years.
However, little is known about the safety and effectiveness of this technique in healthy human subjects. We report the safety and efficacy of a new method of aesthetic keratopigmentation in a clinical case.
This case is reported in accordance with the CARE Clinical Case Reporting guideline. The subject has given written informed consent for publication.

Case study

Information on the subject and problems presented

A 21-year-old woman of North African origin wishing to change the color of her eyes came to the clinic. The subject met the eligibility criteria for the procedure: she is in good general health and had no corneal lesions; the number of corneal cells was not <2,500 cells per square millimeter; she had no cataracts, no keratoconus, and no retinal anomalies. Written consent was obtained after explaining the nature and potential risks of the procedure.

Clinical findings and diagnostic evaluation

The following parameters were evaluated: corneal endothelial cell count (specular microscope, SP-1P, Topcon Corporation, Tokyo, Japan); visual field (model 745, Zeiss Humphrey Instruments, Jena, Germany); refraction in diopters and visual acuity in logMAR; pachymetry and topography (Topograph, TMS-5, Tomey Corporation, Aichi-ken, Japan); and intraocular pressure (Kerato Refractometer KR-1, Topcon Corporation)
The preoperative (May 18, 2016) and postoperative values of corneal endothelial cell count, refraction and visual acuity, pachymetry, and intraocular pressure are shown in Table 1. Differential topographic maps are provided as online supplementary materials (for all online supplementary materials, see www.karger.com/doi/10.1159/000485554).

Chronology

The main aspects of the case report are summarized chronologically in Figure 1.

Surgical procedure and evaluation of results

The preoperative procedure was as follows: Blephaclean wipes for cleaning the eyelids
(1 per eye), twice a day, from 3 days before until the morning of the operation. Five minutes before surgery, a drop of 0.4% oxybuprocaine was instilled into both eyes.

The surgical procedure was as follows: the patient was placed under the laser (VisuMax® femtosecond laser, Carl Zeiss Instruments, Jena, Germany), and the center of the cornea was marked with methylene blue. After the positioning of the laser cone, the eyes were treated with the Intra-Corneal Ring (ICR)® program, making a tunnel for the insertion of intracorneal rings (used in the treatment of keratoconus or moderate myopia).

The surgical parameters were as follows: external diameter, 9.3 mm; internal diameter, 5.5 mm; incision depth, 225μm; 2 radial incisions at 90° and 270°. The tunnel was then dissected with a specially developed and patented round spatula [11] (reference P5042A and P5043A, Duckworth and Kent, Baldock, UK), which was followed by the insertion of Neoris®-Biotic pigment (Paris, France) using the same spatula.

The postoperative regimen was as follows: azithromycin eye drops (Azyter) 1 drop twice daily, starting 2 h after surgery, for 3 days; dexamethasone (Dexafree) eye drops 1 drop twice daily, starting 2 h after surgery, for 2 weeks; trehalose (Thealose) 1 drop 4 times a day, starting 2 hours after the operation, for 3 months; paracetamol 500 mg 1 tablet every 6 hours for 24 hours in case of pain; borage oil (Alphalarm) 1 capsule a day, starting the morning after the operation, for 3 months.

Follow-up and results

Follow-up consisted of patient-perceived outcomes as well as photographic and ophthalmologic evaluations. The surgical procedure went without any complications, and one day after the surgery, the patient said, “Honestly, everything went well, knowing that it’s the second day, I have no pain. I think it feels pretty natural. I’ve had some good feedback, I’m not disappointed.

Eight months after the procedure, the patient reported no problems and was satisfied with the result.
The aesthetic appearance before and 8 months after surgery is shown in Figure 2.
The key ophthalmic safety parameters are shown in Table 1. It is clear from Table 1 that these parameters remained stable during the monitoring period. In addition, optical coherence tomography pachymetry after 8 months (January 25, 2017) is shown in Figure 3.

This figure confirms the stable presence of the pigment at 225 μm depth. There is no evidence of leakage or diffusion of pigment into the cornea.
The visual field was normal (60° temporally on both sides). The preoperative topography compared with the 8-month follow-up topography (differential topography) confirmed that there were no anatomical changes in either cornea (in-line supplemental material). There were no reported side effects at any time during follow-up.

Discussion

To our knowledge, this is the first comprehensive case study describing the safety and efficacy of a surgical procedure for annular keratopigmentation in a healthy subject, in accordance with CARE’s guidelines for clinical case reports. The short- and medium-term safety of the procedure as used in this subject is encouraging: there were no signs of leakage, diffusion, inflammation, or any other adverse effect on the cornea, either objectively or subjectively. The pigment used seems to be stable. The patient’s vision was not negatively affected in any way, and the aesthetic results were good, as underlined by the patient’s high satisfaction.

Perhaps the most sensitive parameter of corneal health is the number of corneal endothelial cells, and it is encouraging to see that this number of cells has remained generally stable. A limitation of this case study is that 8 months of follow-up is insufficient to assess long-term safety. Further medium- and long-term safety data are needed.

We have carefully developed our new surgical technique (called Neoris®) and tested its feasibility in an animal study. We have also designed and developed a special spatula that can be used for corneal tunnel preparation and pigment insertion. The author (F.F.) was the first to use this technique for cosmetic purposes in humans in December 2013. This was a cancer patient who had long wanted to change the color of her eyes. Contact with this patient was maintained, and in August 2017, she reported her satisfaction with the results.
She reported that she was always satisfied with the results and did not experience any side effects from the procedure. This last point is encouraging from a long-term safety perspective.

An important aspect of the procedure is the pigment used. These pigments must be very stable and safe, but they must also look “natural” from an aesthetic point of view.
Further developments and improvements are still possible and necessary in this respect.
The use of corneal tattooing procedures for cosmetic purposes is relatively new in the field of ophthalmology.

To our knowledge, another center has developed a similar procedure in response to the need to treat iris and corneal defects. They published a case series on aesthetic corneal tattooing using 3 different techniques, including femtosecond-assisted keratopigmentation. In general, the safety of the procedure has been confirmed.
However, in some of their patients, a second procedure to correct the color was required, and all patients reported mild to moderate photophobia, ranging from 2 weeks to 3 months after surgery. In our patient, no color correction was necessary, no photophobia was reported after surgery and the aesthetic appearance seems more natural. The different pigment we use could explain this.

To date (October 2017), we have treated 63 cases with this procedure, with positive results in terms of safety and effectiveness. In a next step, we plan to publish a series of cases, showing results in a wide variety of subjects.
For this procedure to be acceptable for purely aesthetic purposes, an excellent and healthy profile is an important requirement. This case and our other experiences to date are very encouraging in this regard. Our procedure is a promising, safe and effective emerging possibility for those who desire femtosecond-assisted annular keratopigmentation for purely aesthetic reasons, as well as for patients with ophthalmologic pathologies affecting the appearance of the eyes.

Acknowledgements

We thank Dr. Mark Bischoff and the late Dr. Jean-Paul Tiziano for their help in the development of this surgical technique since its beginning.

Statement of ethics

This case is reported in accordance with the CARE Clinical Case Reporting guideline. The subject has given written consent for publication.

Disclosure Statement

Francis Ferrari is the co-owner of Neoris®, which is a distributor of the dye used.

Scientific article DOI: 10.1159/000487345

References

Ziegler SL, Multicolor tattooing of the cornea. Trans Am Ophthalmol Soc 1922;20:71-87.

Hirsbein D, et al, Corneal tattooing for iris defects (in French). J Fr Ophthalmol 2008;31:155-164.

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;95:1397-1401.

Alió JL, et al: Femtosecond-assisted keratopigmentation for functional and cosmetic restoration in
essential iris atrophy. J Cataract Refract Surg 2011;37:1744-1747.

Roy JN: Tattooing of the cornea. Can Med Assoc J 1938;39:436-438.

Pitz S, et al: Corneal tattooing: an alternative treatment for disfiguring corneal scars. Br J Ophthalmol
2002;86:397-399.

Kymionis GD, et al: Femtosecond-assisted anterior lamellar corneal staining-tattooing in a blind eye
with leukocoria. Cornea 2009;28:211-213.

Laria C, Alió JL, Piñero DP: Intrastromal corneal tattooing as treatment in a case of intractable
strabismic diplopia (double binocular vision). Binocul Vis Strabismus Q 2010;25:238-242.

Alio JL, et al: Femtosecond-assisted keratopigmentation double tunnel technique in the management of a case of Urrets-Zavalia syndrome. Cornea 2012;31:1071-1074.

Gagnier JJ, et al: The CARE guidelines: consensus-based clinical case report guideline development. J Clin Epidemiol 2014;67:46-51.

Ferrari F: Surgical hand instrument. I.N.P.I. (Institut National de la
Industrial Property), France, 2017.

Ferrari F, et al: Annular keratopigmentation (or PresbyRing®) in the management of
presbyopia: a post-mortem experimental feasibility study in animals. J Fr Ophthalmol 2013; 36:481-487.

Ferrari F, Morin L: Description of a new method of changing eye color: case report of aesthetic annular keratopigmentation (AAK). J Fr Ophthalmol 2015;38:e3.

Alió JL, et al: Keratopigmentation to change the apparent color of the human eye: a novel indication for corneal tattooing. Cornea 2016;35:431-437.