INTRACORNEAL RING SEGMENTS

VISION IN EVOLUTION

INNOVATION, QUALITY AND EVOLUTION ARE PART OF OUR VISION

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Founded in 1971 by ophthalmologist Emyr Soares M.D. PhD., Mediphacos is today a world-class international company with presence in over 60 countries across 5 continents. We are dedicated to restoring, preserving and improving human eyesight in cooperation with ophthalmologists through creation, production and distribution of high quality products and services. Mediphacos has achieved a prominent position in the global market by investing heavily in research, development and innovation, constant technological progress and focusing on the evolving needs of ophthalmologists. In our modern production plant, we use only the best materials and technologies available worldwide, developing innovative products of the highest quality, safety and efficacy.

Mediphacos boasts a comprehensive quality assurance system in all levels of the enterprise and certified in compliance with ISO 9001, ISO 13485, GMP and other relevant standards.

THE WORLD LEADER IN THE TREATMENT OF KERATOCONUSINTRASTROMAL CORNEAL RING SEGMENTS

KERARING® intrastromal corneal ring segments are precision implantable devices for the correction of corneal surface irregularities and reduction of refractive errors associated with keratoconus and other corneal ectatic disorders.

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The KERARING® range offers over 50 options of thicknesses, arc lengths and diameters, allowing for significant customization of corneal remodelling and refractive correction.

VARIABLE ARC LENGTHS AND THICKNESSES

340° 210° 160° 150° 120° 90°

MECHANISMS OF ACTION

Corneal remodeling through addition technique, preserving the corneal integrity;

Corneal topography regularization and refractive correction, preserving the natural corneal prolate profile;

Reduction of optical aberrations and improvement of visual acuity;

Improvement of contact lens tolerance;

Delays or eliminates the need for corneal transplantation;

Accute keratoconus with keratometry > 70 D; Extensive central corneal opacities;Active hydrops;Post penatrating keratoplasty, when the graft is decentered;Severe atopic disease;Recurrent corneal erosion syndrome; High expectations of emmetropia.

CONTRAINDICATIONS

Keratoconus with decreased BSCVA and intolerance to contact lens wear;Pellucid marginal degeneration;Post-LASIK corneal ectasia;Irregular astigmatism post-RK, post-penetrating keratoplasty or post-trauma;

INDICATIONS

INTRACORNEAL RING SEGMENTS

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PROVEN CLINICAL SAFETY

KERARING® patients report high levels of satisfaction, with positive impacts on their quality of life.

“KERARING® implantation resulted in a significant improvement in all variables of the NEI-RQL questionnaire": (Clarity of vision, distance and near vision, limitation of activities, satisfaction with the correction, UCVA, BCVA, keratometric values, contrast sensitivity).2

"KERARING® not only improves the quantitative metrics of vision, it also has a positive effect on the quality of life of patients"2.²

QUICK RECOVERYHIGH SATISFACTION RATESMinimally invasive surgical technique allows patients to quickly resume their normal activities. Topographic and refractive changes start immediately after implantation and stabilize after 3 months on average.

“THE KERARING PROVIDES THE MAIN IMPROVEMENT IN VISION”3³

Variable

ylevitarepotsoPom6ylevitarepotsoPom3ylevitarepotsoPom1

Mean 6 SD P Mean 6 SD P Mean 6 SD P

UCVA 0.27 6 0.22 , 0.05 0.35 6 0.24 , 0.05 0.32 6 0.25 , 0.05BSCVA 0.48 6 0.22 , 0.05 0.57 6 0.25 , 0.05 0.57 6 0.24 , 0.05Sphere 2 1.97 6 3.05 , 0.05 2 2.25 6 3.05 , 0.05 2 1.89 6 2.68 , 0.05Cylinder 2 2.29 6 1.66 , 0.05 2 1.99 6 2.14 , 0.05 2 2.60 6 1.62 , 0.05SE 2 3.11 6 3.13 , 0.05 2 3.25 6 3.53 , 0.05 2 3.19 6 2.75 , 0.05

K max 47.97 6 4.01 , 0.05 48.97 6 4.27 , 0.05 48.85 6 4.45 , 0.05

K min 44.84 6 3.37 , 0.05 45.55 6 3.99 , 0.05 45.69 6 3.25 , 0.05

K average 46.40 6 3.49 , 0.05 47.26 6 3.84 , 0.05 47.27 6 3.68 , 0.05

25 YEARS OF FOLLOW-UP AND OVER 400 THOUSAND IMPLANTS WORLDWIDESTABLE KERATOMETRIC, VISUAL AND REFRACTIVE CHANGES

"There was a statistically significant improvement in all the variables studied in all postoperative evaluation times."1¹

KERARING® implantation may be synergistically combined with other techniques such as corneal collagen crosslinking, PRK and phakic IOL implantation.

COMPATIBLE WITH COMPLEMENTARY TECHNIQUES

FEATURES AND BENEFITS:

KERARING® unique cross sectional shape produces a prismatic effect to reflect incoming light, thus minimizing glare and halos.

KERARING® is available in two models: SI-5 for 5 mm optical zone implantation and SI-6 for 6 mm implantation; providing more options to address the needs of each individual case.

EXCLUSIVE PRISMATIC DESIGN

VARIABLE OPTICAL ZONES

5.0 mm

SI - 5 SI - 6

5.5 mmou

6.0 mm

Refractive and topographic effects can be easily adjusted by exchanging and or repositioning the implant.

REVERSIBILITY

KERARING® does not interfere with the normal execution of lamellar or penetrating keratoplasty procedures, if and when needed.

ADJUSTABILITY

KERARING® may be explanted at any time, allowing the cornea to return to its original characteristics.

DOES NOT COMPROMISECORNEAL GRAFT

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150µm 150µm200µm 200µm250µm 250µm300µm 300µm

350µm

90°

150µm 150µm200µm 200µm250µm 250µm300µm 300µm350µm 350µm

120°

150µm200µm250µm300µm350µm

150° 150µm200µm250µm300µm350µm

160°

150µm 150µm200µm 200µm250µm 250µm300µm 300µm350µm 350µm

210°

150µm200µm250µm300µm

325°

150µm200µm 200µm250µm300µm 300µm

340°

ARCOPTICAL ZONE AND THICKNESS

SI5 SI6

ARCOPTICAL ZONE AND THICKNESS

SI5 SI6

ARCOPTICAL ZONE AND THICKNESS

SI5 SI6

ARCOPTICAL ZONE AND THICKNESS

SI5 SI6

ARCOPTICAL ZONE AND THICKNESS

SI5 SI6

ARCOPTICAL ZONE AND THICKNESS

SI5 SI6

ARCOPTICAL ZONE AND THICKNESS

SI5 SI6

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CONSULTANCY SERVICES

The proper selection of KERARING® segment size and position for each cornea is important to the outcome of the procedure. Mediphacos regularly updates its nomograms and surgical planning guidelines based on the statistical analysis of thousands of cases. Expert consultants are avaliable to discuss individual cases and help devise customized surgical plans. www.mediphacos.com/keraring

KERARING® implantation is a simple procedure with a short learning curve, performed under topical anesthesia in an outpatient setting. Surgical instruments were developed specifically for manual dissection and femtosecond laser assisted techniques. Before implanting KERARING® , surgeons should participate in one of the certification courses offered by Mediphacos and its distributors. Contact us today to request the updated course schedule or a personalized training in your own clinic.

SURGICAL TECHNIQUE AND TRAINING

KERARING® AS is the first and only intrastromal ring segment with progressive thickness. It allows for even greater treatment customization options when planning to achieve optimal visual and refractive outcomes for each individual case.

The KERARING® AS is implanted by using existing techniques and instrumentation.

The KERARING® AS is available in 160o arc length, 5mm diameter and the following progressive thicknesses:200µm to 300µm ( clockwise and counter-clockwise )150µm to 250µm ( clockwise and counter-clockwise )

INDICATIONS

Keratoconus, ectasia after LASIK and irregular

astigmatism after transplantation with asymmetric

topographical features.

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INTRACORNEAL RING SEGMENTS

150µm-250µm Clockwise150µm-250µm counter-clockwise

200µm-300µm Clockwise200µm-300µm counter-clockwise

160° SI5

ARC OPTICAL ZONE THICKNESS PROGRESSION

Mediphacos S/AAv. Cristovam Chiaradia, 777Belo Horizonte | Minas Gerais 30575-815 | Brazil Phone: +55 31 2102 2211 Fax: + 55 31 2102 2212 www.mediphacos.com

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VISION IN EVOLUTION

REFERENCES1. Cornea. 2012 Feb;31(2):115-20. KeraRing intrastromal corneal ring segments for correction of keratoconus.Gharaibeh AM1, Muhsen SM, AbuKhader IB, Ababneh OH, Abu-Ameerh MA, Albdour MD.

2. Br J Ophthalmol. 2010 Jan;94(1):101-5. Evaluation of the impact of intracorneal ring segments implantation on the quality of life of patients with keratoconus using the NEI-RQL (National Eye Institute Refractive Error Quality of life) instrument.de Freitas Santos Paranhos J1, Avila MP, Paranhos A Jr, Schor P.

3. Cataract & Refractive Surgery Today - Europe. 2009 October. Pietrini D, Guedj T.

SPECIFICATIONSMaterial: PMMA CQ UV Variable thickness: 150µm / 200µm / 250µm / 300µm / 350µmOptical Zone: 5 mm or 6 mmVariable arc lengths:

340° 210° 160° 150° 120° 90°

INTRACORNEAL RING SEGMENTS