It is now possible to surgically change eye color, without affecting the ability of an ophthalmologist to perform eye care after keratopigmentation.

The process dates back to Ancient Greece. Indeed, the physician Galen was already practicing corneal tattooing. This was 2,000 years ago, when he used Indian ink. The keratopigmentation takes up this practice, but improves and modernizes it by what Galen lacked: a femtosecond laser. From its full name name Femtosecond Assisted Keratopigmentation, keratopigmentation is a surgical procedure surgical method of applying pigment to the cornea, directly in front of the natural color of the iris. It does not affect the internal structures of the eye. No implants are introduced. Performed by specialized ophthalmic ophthalmologists, the operation lasts 30 minutes and is performed under local anesthesia. The result: the color of the eyes changes. But two questions are regularly asked by ophthalmologists: is the technique safe, and can an eye be treated after keratopigmentation?

Is it possible to have identical eye care after surgery?

This scientific article answers the second question: is it possible to perform eye care after keratopigmentation? Will the ophthalmologist interpret the data from an eye data from a keratopigmented or non-keratopigmented eye? To determine this, a study study was carried out at the Espace Nouvelle Vision clinic in Paris. Thirty patients underwent eighteen women and twelve men, aged between 24 and 48. years of age. Six months later, they were clinically tested by three different ophthalmologists. ophthalmologists.

What was the conclusion? For the sixty eyes operated on, iris and retina examinations and retina examinations were possible, with no additional difficulties. The same was true for the results obtained using multimodal imaging techniques: the interpretation interpretation was equally straightforward

All in all, the results are clear. Keratopigmentation is reliable, both aesthetically aesthetically and safely. No difficulties were observed in the post clinical examination, multimodal imaging or follow-up of patients with glaucoma patients with glaucoma, retinal and/or corneal pathologies. Screening for all ocular pathologies is feasible. Experience has also shown that, if cataract surgery is necessary, having keratopigmented eyes does not interfere with it. the few cases who have undergone both operations have both been successful.

An operation like any other, which does not preclude others, keratopigmentation is therefore the best alternative for those wishing to change their eye color the color of their eyes.

L’article Eye care after keratopigmentation est apparu en premier sur Neoris.

Introduction

It is known that the placement of a pinhole within the cornea results in an increase in depth of field and thus improves near and intermediate visual acuity. This principle has been used since 2011 in the field of corneal refractive surgery through the Kamra^® type intracorneal ring technique. This is an additive and reversible surgery whose main advantage is that it does not deteriorate distance vision and allows near vision in emmetropic or ametropic presbyopic patients. Implantation in the pupil area requires mechanical or femtosecond laser-assisted cutting of a LASIK-type cap or the creation of a stromal pocket. The Kamra^®inlay is then placed in the bed or pocket around the patient’s previously identified and marked optical axis. This intracorneal implant is made of polyvinylidene fluoride whose biocompatibility has yet to be determined. The external diameter is 3.8 mm and the internal diameter is 1.6 mm. It has numerous micro-perforations designed to facilitate the passage of corneal metabolites (nutrients, electrolytes). The Kamra^® implant has undergone successive improvements, including a reduction in thickness (currently five microns) and an increase in the number and distribution of micro-perforations. Although the refractive results seem promising, the limited experience with the use of this biomaterial in the cornea has already led to the observation of certain complications:

• due to the biomaterial: intracorneal iron deposits, diffuse inflammation of the interface, and thinning of the overlying stroma. A confocal microscopy study showed no evidence of intrastromal tissue alteration following placement of a Kamra implant. Another study showed an increase in inlay-induced apoptosis and inflammatory markers in the cornea 24 to 48 hours after surgery with normalization of these parameters six weeks after implantation;

• due to the pinhole effect: loss of visual acuity lines in distance vision, the occurrence of a hypermetropic shift, nocturnal light halos, monocular diplopia;

• due to cutting: dry eyes, loss of visual acuity line.

In addition, the high cost of the implant is a limiting factor for a wider diffusion of this technique whose concept is nevertheless attractive.

Corneal tattooing is a very old technique, already described by Galen in the 2nd century with the aim of masking a corneal scar or a white cataract by applying walnut or pomegranate bark on a previously cauterized cornea. Later on, Dr. Wecker used Chinese ink by means of non-piercing micro-needles, still in the cosmetic treatment of leukoma. Victor Morax treated the opaque corneas of his patients by introducing a dye into a pre-dissected corneal pocket. More recently, keratopigmentation has been revived for the treatment of iris defects, this time using dyes that meet European standards (Biochromaderm^®, Laboratoire BioticPhocea, Marseille, France [SNCH certification n^o. 0499, sheet 17B, 2011-07-01, Luxembourg]). Thus, in recent years, keratopigmentation has become much “safer” thanks to the use of purified and inert dyes that no longer interact with the surrounding tissues and is increasingly aimed at sighted eyes with iris anomalies.

The combination of the two techniques, intracorneal ring on one hand, and keratopigmentation on the other hand, it seems to us to be at the origin of new corneal surgery techniques, including the treatment of presbyopia. The purpose of our study is to use the keratopigmentation technique to create an intrastromal concentric black (or colored) annular centered on the visual axis, with an internal diameter of slightly less than 2 mm, likely to produce a pinhole effect (Patented technique, U.S. Provisional Application No. 61/713,013). We present here the results of a preliminary feasibility study performed on pig eyes.

Section snippets

Material and methods

Five eyes of pigs were enucleated eight hours before the experiment was used (Strasbourg slaughterhouses). The laser used was a femtosecond laser (Visumax^®, Jena, Carl Zeiss^®). The eyes were treated with the Intra Corneal Ring (ICR^®) program corresponding to the creation of tunnels for intracorneal rings (used for keratoconus and the treatment of moderate myopia). The parameters of the tunnel diameters were modified as follows: internal diameter: 1.8 mm,

Results

Corneal imagery by anterior segment spectral-domain OCT allowed control of the depth and regularity of the stromal cutout serving as a bed for the dye injection, as well as the loss of corneal reflectivity related to the “mask effect” of the pigment. For the control eye, the cutting interface was visualized at a depth of 221 μm (Fig. 4).

A linear hyperreflective blade located at the cutting interface and associated with a posterior shadow cone has been implemented

Discussion

The surgical treatment of presbyopia has progressed considerably in recent years. Several surgical approaches have been successively proposed: central island, decentered island, centered bulging ring, and tilt techniques. In spite of the constant improvement of these techniques, in particular the techniques of tilting with an increase of the depth of field and improvement of the binocular vision, the patients are sometimes embarrassed in distance vision by the visual acuity of

Conclusion

This study represents, to our knowledge, the first experimental attempt to bring together two a priori distant concepts: the creation of an intracorneal pinhole to treat presbyopia on the one hand, and corneal tattooing on the other. The first feasibility study of annular keratopigmentation (PresbyRing^®) in post-mortem animals gave encouraging results. It must be confirmed by other studies carried out in animals in vivo and then

Declaration of interest

The authors declare that they have no conflicts of interest in relation to this article.

Scientific article DOI : https://doi.org/10.1016/j.jfo.2013.01.004

References (18)

• J.L. Alió et al. Femtosecond-assisted keratopigmentation for functional and cosmetic restoration in essential iris atrophy J Cataract Refract Surg (2011)

• D. Hirsbein et al. Corneal tattooing for iris defects J Fr Ophtalmol (2008)

• A.K. Dexl et al. Reading performance and patient satisfaction after corneal inlay implantation for presbyopia correction: two-year follow-up J Cataract Refract Surg (2012)

• O. Seyeddain et al. Small-aperture corneal inlay for the correction of presbyopia: 3-year follow-up J Cataract Refract Surg (2012)

• A.K. Dexl et al. Reading performance after implantation of a small-aperture corneal inlay for the surgical correction of presbyopia: two-year follow-up J Cataract Refract Surg (2011)

• A.K. Dexl et al. Central and peripheral corneal iron deposits after implantation of a small-aperture corneal inlay for correction of presbyopia J Refract Surg (2011)

• D.I. Bouzoukis et al. Visual outcomes and safety of a small diameter intrastromal refractive inlay for the corneal compensation of presbyopia J Refract Surg (2012)

• M.R. Santhiago et al. Short-term cell death and inflammation after intracorneal inlay implantation in rabbits J Refract Surg (2012)

L’article Annular keratopigmentation (or PresbyRing®) in the management of presbyopia: an experimental feasibility study in animals. est apparu en premier sur Neoris.

F. Ferrari, L. Morin

The principle of annular keratomigmentation has already been described in an animal feasibility study for the treatment of presbyopia.

The aim of this study is to show the good tolerance of AAK on humans, its absence of complications, and its results on the aesthetic level.

A 49-year-old female patient underwent surgery bilaterally in December 2013. She had brown eyes and wanted to change the color of her eyes to green. We used the ICR program of the Visumax femtosecond laser (Zeiss*) with 4 incisions and a very large diameter at a depth of 150 microns. After dissection of the tunnel created with the laser, green pigment (Biotic Phocéa) was then injected into this tunnel. This pigment has been approved for corneal use.

Three months after the operation, the after-effects are simple, without inflammatory reaction, without diffusion of the dye in the cornea. Corrected visual acuity (10/10ths in both eyes) and visual fields were unchanged. The aesthetic result is satisfactory, with the creation of a pseudo pupil and a limbal annular (Fig. 1)

Aesthetic annular keratopigmentation is a new method for changing eye color. The first case performed on a man shows a satisfactory aesthetic result without local or functional complications. Other studies will have to be carried out to confirm the safety of the procedure, as well as its aesthetic interest.

Declaration of interest The authors declare that they have no conflicts of interest in relation to this article.

Scientific article DOI : http://dx.doi.org/10.1016/j.jfo.2014.04.022

Reference

Ferrari F, Letsch J, Morin L, Guignier A, Marcellin L, Bourcier T. La kératopigmentation annulaire dans la prise en charge de lapresbytie. J Fr Ophtalmol (2013) ; 36 : 481—7

L’article Description of a new method to change eye color. A case report of aesthetic annular keratopigmentation (AAK) est apparu en premier sur Neoris.

F. Ferrari

Purpose:

The purpose of this study is to show the good tolerance of AAK, an absence of complications and the results obtained from an aesthetic point of view.

Setting:

Clinique Ste Odile, Strasbourg, France

Methods:

Surgery was performed on both eyes of a 49-year old patient at the ‘Expert Vision Center’ of Strasbourg, France, in December 2013. She had brown eyes and wanted to change their color to green.We used the ICR program of the Visumax femtosecond laser (Zeiss) to make 4 incisions and a very large diameter at 150 microns depth. After dissection of the tunnel created by the laser, a green Pigment (Biotic Phocéa) was then injected into this tunnel. This pigment has received approval for corneal use.

Results:

The follow up 3 months after surgery showed that there were no complications, no inflammatory reaction, and no diffusion of the dye into the cornea. Visual acuity (20/20 for both eyes) and the visual fields remained unchanged. The aesthetic results are pleasing, with the creation of a pseudopupil and a limbal ring.

Conclusions:

Aesthetic Annular Keratopigmentation intends to be a new method to change eye color. The first case of surgery performed on a human reveals a satisfactory aesthetic result without any local or functional complications. Other studies need to be conducted to confirm the safety of the procedure and its aesthetic interest. FINANCIAL INTEREST: NONE

L’article Description of a new method to change eye colour called ‘aesthetic annular keratopigmentation’ (AAK) est apparu en premier sur Neoris.

F. Ferrari, R. van Haselen

Abstract

Background:

We investigated the safety and effectiveness of a novel aesthetic femtosecond-assisted annular keratopigmentation technique.

Case Report:

A 21-year-old female patient in good general and ophthalmological health with the wish to change the color of her eyes. She was treated with a femtosecond-assisted annular keratopigmentation technique. Pigment was inserted in a channel in the cornea (external diameter 9.3 mm; internal diameter 5.5 mm)
created with a femtosecond laser at a depth of 225 μm. Eight months post-operatively, there were
Eight months post-operatively, there were no signs of leakage, diffusion, inflammation, or any other detrimental effects on the cornea both objectively and subjectively.

Conclusion:

This procedure is a promising safe and effective option for those who want annular keratopigmentation for aesthetic reasons.

Introduction

Corneal tattooing has been in long use and was first mentioned by Galen in the 1st century. These techniques are mainly used for therapeutic purposes, in patients with iris defects, corneal scars, leukocoria, strabismic diplopia, and Urrets-Zavalia syndrome Further improvements in the surgical techniques, as well as the dyes used, have led to an increasing interest in corneal tattooing for aesthetic purposes in recent years.
Little is known, however, about the safety and effectiveness in healthy human subjects. We report on the safety and effectiveness of a novel aesthetic keratopigmentation method in a clinical case.
This case is reported in accordance with the CARE Clinical Case Reporting guideline. The subject provided written informed consent for publication.

Case Report

Subject Information and Presenting Concerns

A 21-year-old female of Maghreb origin with the wish to change the colour of her eyes presented herself at the clinic. The subject met the eligibility criteria for the procedure: she was in good general health and had no corneal damage; corneal cell count was not <2,500 cells per square millimeter; she had no cataract, no keratoconus, and no retinal abnormalities. Written consent was obtained after the nature and potential risks of the procedure were explained.

Clinical Findings and Diagnostic Assessment

The following parameters were assessed: corneal endothelial cell count (specular microscope, SP-1P, Topcon Corporation, Tokyo, Japan); visual field (Model 745, Zeiss Humphrey Instruments, Jena, Germany); refraction in dioptres and visual acuity in logMAR; pachymetry and topography (Topographer, TMS-5, Tomey Corporation, Aichi-ken, Japan); and intraocular pressure (Kerato Refractometer KR-1, Topcon Corporation).
The pre-operative (May 18, 2016) and postoperative values for corneal endothelial cell count, refraction and visual acuity, pachymetry, and intraocular pressure are given in Table 1. The differential topographical maps are provided as online supplementary material (for all online suppl. material, see www.karger.com/doi/10.1159/000485554).

Time Line

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

Surgical Procedure and Outcome Assessment

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

The surgical procedure was as follows: the patient was placed under the laser (femto- second laser VisuMax®, Carl Zeiss Instruments, Jena, Germany), and the center of the cornea was marked with methylene blue. After positioning of the laser cone, the eyes were treated with the Intra-Corneal Ring (ICR)® program, making a tunnel for 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; depth incision, 225 μm; 2 radial incisions at 90° and 270°. The tunnel was then dissected with a specially developed and patented [11] round spatula [11] (reference P5042A and P5043A, Duckworth and Kent, Baldock, UK), which was followed by the insertion of the pigment Neoris®-Biotic (Paris, France) using the same spatula.

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

Follow-Up and Outcomes

The follow-up consisted of patient-perceived outcomes as well as photographic and ophthalmological assessments. The surgical procedure took place without any complications, and 1 day post-operatively, the patient reported: “Honestly, everything went well, knowing that it is the second day, I have no pain anymore. I find it looks natural enough, I have had some good comments, I am not disappointed.”

Eight months after the procedure, the patient reported to have experienced no problems and being satisfied with the result.
The aesthetic aspect before and 8 months after the procedure is depicted in Figure 2.
The principal ophthalmological safety parameters are given in Table 1. It is clear from Table 1 that these parameters were stable during the follow-up period. In addition, optical coherence tomography pachymetry after 8 months (January 25, 2017) is depicted in Figure 3.

This figure confirms the stable presence of the pigment at 225 μm depth. There is no sign of leakage or diffusion of the pigment in the cornea.
The visual field was normal (60° temporally on both sides). The pre-operative topography compared to the 8-month follow-up topography (differential topography) confirmed that there were no anatomical changes in both corneas (online suppl. material). There were no reported side effects at any time during follow-up.

Discussion

To our knowledge, this is the first comprehensive case report describing the safety and effectiveness of an annular keratopigmentation surgical procedure in a healthy subject, in line with the CARE clinical case reporting guidelines. The short- and medium-term safety of the procedure as employed in this subject is encouraging: there were no signs of leakage, diffusion, inflammation, or any other detrimental effects on the cornea both objectively and subjectively. The pigment utilized appears to be stable. The vision of the patient was not affected negatively in any way, and the aesthetic results were good, as underlined by the high satisfaction of the patient.

Arguably, the most sensitive parameter of corneal health is the corneal endothelial cell count. It was encouraging to see that this cell count remained stable overall. A limitation of this case report is that 8 months of follow-up are insufficient for the assessment of long-term safety. Further medium- as well as long-term safety data are required.

We carefully developed our novel surgical technique (referred to as Neoris®) and piloted its feasibility in an animal study. Also, a special spatula that can be used for the preparation of the corneal tunnel and the insertion of the pigment was designed and developed. The author (F.F.) was the first to use this technique for aesthetic purposes in humans in December 2013. This concerned a cancer patient who had a long-held desire to change eye color. Contact with this patient was maintained, and in August 2017, she reported her continued satisfaction with the results.
She reported her continued satisfaction with the results as well as an absence of any procedure-related side effects. The latter is encouraging from a long-term safety perspective.

An important aspect of the procedure is the pigment that is used. These pigments need to be highly stable and safe but also need to look “natural” from an aesthetic perspective.
Further development and improvements in this regard are still possible and required.
The use of corneal tattooing procedures for aesthetic purposes is relatively novel in the field of ophthalmology.

To our knowledge, 1 other center developed a similar procedure in response to the need for treating iris and cornea defects They published a case se- ries on aesthetic corneal tattooing using 3 different techniques, including femtosecond-assisted keratopigmentation . In general, the safety of the procedure was confirmed.
However, in some of their patients, a second procedure for correction of the color was required, and all patients reported mild to moderate photophobia, ranging from 2 weeks to 3 months post-operatively. In our patient, no color correction was necessary, nor was photo-phobia reported post-operatively, and the aesthetic aspect seems to be more natural. The different pigments we are using could explain this.

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

Acknowledgements

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

Statement of Ethics

This case is reported in accordance with the CARE Clinical Case Reporting guideline. The subject provided written informed 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: Instrument à main chirurgical (surgical hand instrument). I.N.P.I. (Institut National de la
Propriété Industrielle), France, 2017.

Ferrari F, et al: La kératopigmentation annulaire (ou PresbyRing®) dans la prise en charge de la
presbytie: étude expérimentale de faisabilité post-mortem chez l’animal. J Fr Ophtalmol 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 Ophtalmol 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.

L’article The Safety and Effectiveness of a Novel Annular Keratopigmentation Method: A Case Report est apparu en premier sur Neoris.