In the name of GOD Intrastromal Femtosecond Incision ( Intracor) Seyed Javad Hashemian MD Eye Research Center Rassoul Akram Hospital TUMS No financial interest 18/October/2012

The Presbyopia Opportunity Large market 20+% of population are presbyopic = 1.5 billion, about one quarter come from wealthy nations, approx. 350 million – and growing … Favorable Eco-nomics Economic situation of presbyopic age group is favorable, e.g. vs. the typically younger, less affluent LASIK patients Growing Demand Modern life becomes more and more demanding for near and inter-mediate vision (cell phone, computer, …) 2 © 2010 Technolas Perfect Vision. All rights reserved.

3 © 2010 TECHNOLAS PERFECT VISION. All Rights Reserved. Classical solutions: Glasses & Contact Lenses Glasses & Contact Lenses Multi- and bi-focals contact lenses & spectacles Multi- and bi-focals contact lenses & spectacles Monovision Monovision Surgical solutions: Surgical solutions: IOLs: Multifocal refractive and diffractive and accommodative concepts IOLs: Multifocal refractive and diffractive and accommodative concepts Scleral methods: Relaxating incisions, Implants Scleral methods: Relaxating incisions, Implants Lens manipulations to increase accommodation Lens manipulations to increase accommodation Corneal solutions: Corneal solutions: Monovision based refractive correction Monovision based refractive correction Corneal Inlay Corneal Inlay Refractive inlays, pinhole inlays ; KAMRA Inlay Refractive inlays, pinhole inlays ; KAMRA Inlay INTRACOR INTRACOR Conductive keratoplasty Conductive keratoplasty Presbyopic LASIK Presbyopic LASIK Supracor Supracor Presbyopia solutions A variety of solutions exist to address Presbyopia:

DEPTH OF FOCUS AND OPTICAL ABERRATIONS Depth of focus determines the distance range for which a target can be seen clearly without change in focusing power. The depth of field depends on several factors, including The optical properties of the eye (pupil diameter, accommodation level, monochromatic and chromatic aberations, diffraction), The optical properties of the eye (pupil diameter, accommodation level, monochromatic and chromatic aberations, diffraction), Retinal and visual processing properties (photoreceptor size and ganoglion cell density, visual acuity and contrast thresholds, ocular pathway disease, Target properties (luminance, space detail, contrast, color spectral profile).

Spherical Aberration

When an optical system suffers from some amount of optical aberrations (here positive spherical aberration), the depth of focus is increased, due to the relative maintaining o f the width of the point spread function (PSF l with the anterior displacement of the 'image plane. The depth of focus

The aim of these incisions is to induce a local reorganization of the biomechanical forces and a change in corneal shape. The net effect is a central steepening of the anterior corneal surface Intracor The intrastromal femtosecond incision procedure delivers a series of 5 femto-disruptive cylindrical rings beginning within the posterior stroma, at a variable distance from Descemet membrane, and extending anteriorly through the midstroma to an anterior location at a predetermined distance beneath Bowman layer.

IntraCor: FemtoSecond Laser cut inside the tissue. ( 1.8mm- 3.2mm) Utilizes bio-dynamic properties of the cornea. Generates central steepening to provide near addition.

The Intracor causes a biomechanical causes a biomechanical change in the cornea that shifts the center slightly forward, creating a pattern of hyperprolate asphericity that gives the person some near vision while still maintaining distance vision change in the cornea that shifts the center slightly forward, creating a pattern of hyperprolate asphericity that gives the person some near vision while still maintaining distance vision So this is a procedure for correcting presbyopia in mild hyperopic patients with normal distance vision. Intracor

Intracor It is an entirely biomechanical method that never breaks the surface epithelium. –As a result, there is no migration of white blood cells coming in from the tear film and no aggressive healing response. No real pain is involved because you are not breaking the surface and exposing nerve fibers. No real pain is involved because you are not breaking the surface and exposing nerve fibers. In addition, the little bubbles that form from the femtosecond pulses in the cornea all dissolve within the first day or evening, and patients see well within hours.” In addition, the little bubbles that form from the femtosecond pulses in the cornea all dissolve within the first day or evening, and patients see well within hours.”

INTRACOR Presbyopia – Mechanism IOP © 2009 Technolas Perfect Vision. All rights reserved Oo

Purely intrastromal refractive treatment with Technolas PV femtolaser. No cut of epithelium, Bowman’s or Descements. Cut design and stromal depth algorithm depending on refractive error. Duration approx. 20 seconds

Intracor Preliminary results show good uncorrected near visual acuity postoperatively and no major loss in UDVA. Relative stability of total aberrations and HOAs is described, with a shift in primary spherical aberration toward negative values and secondary spherical aberration toward positive values. Relative stability of total aberrations and HOAs is described, with a shift in primary spherical aberration toward negative values and secondary spherical aberration toward positive values. Biomechanical studies (obtained with the Ocular Response Analyzer, Reichert, Inc.) reveal only a slight reduction of corneal resistance factor with no modifications of the corneal hysteresis, both indicators of the viscoelastic properties of the cornea. Biomechanical studies (obtained with the Ocular Response Analyzer, Reichert, Inc.) reveal only a slight reduction of corneal resistance factor with no modifications of the corneal hysteresis, both indicators of the viscoelastic properties of the cornea.

Preop Evaluations BCDVA,UCDVA, BCNVA,UCNVA Cycloplegic and Manifest refraction Slit-lamp examination Applanation tonometry, Applanation tonometry, Dilated fundus examination. Topography (Tomography; Orbscan II,Intracalc) Ultrasound Pachymetry Wavefront Aberrometry Endothelial cell counts,

Surgical Pearls Documented stable refractive error Realistic expectations –enhance near vision Best patients –late 40s, hyperopia D No ocular surface disease. Non dominant eye Aberrometry Close agreement between manifest and cycloplegic Rx Ultrasound Pachymetry ≥ 500µ

Clinical recommendations Presbyopia Inclusion criteria for presbyopic patients Start with D Both eyes with cc vision >= 0.8 No previous surgery, clear medias Exclude keratoconus suspects Exclude keratoconus suspects Start with mean K-readings at approx and 44.0D Maximal 0.5D difference between cyclo and manifest refraction Near addition of +2.0D needed Angle Kappa < 10° >= 50 years

Reasonable expectations glare, halos, double vision Be carefully with people demanding very good distance vision Reasonable expectations + good result => happy patients Clinical recommendations Presbyopia

Bilateral treatment for all patients with MRSE in the range of to 1.25 D For patients with MRSE between 0.50 and 0.75 D, simulate the myopic shift of D (or D as a worst-case simulation) with contact lenses. simulate the myopic shift of D (or D as a worst-case simulation) with contact lenses. If the patient agrees with the distance vision, the bilateral INTRACOR treatment is advised. Clinical recommendations Presbyopia

Simulation test of decreased distance vision –Give patient trial frame with best distance correction, and afterwards add D sphere to simulate potential blur –„This might be the distance vision after surgery“ –If patient does not like => Don‘t treat! Alginment under laser –Pupil Center or Inbetween Apex & Pupil Center Postoperative care –Like standard LASIK –Older patients: more artificial tears required –Full quality of vision obtained over a postoperative period of 1-3 months Clinical recommendations Presbyopia

Complementary Offering of SUPRACOR and INTRACOR Provides True Solutions for Presbyopia PLUS: e.g. INTRACOR for post-cataract patients with monofocal IOLs PLUS: e.g. INTRACOR for post-cataract patients with monofocal IOLs 21 SUPRACORSUPRACORSUPRACORSUPRACORINTRACORINTRACOR

2 hr Post Op 1 Day Post Op1 Months Post Op 1 hr Post Op

IntaCor Topographic Changes

IntraCOR for Intrastromal Presbyopia Correction: One-year results revealed a stable uncorrected near visual acuity (UNVA) with statistically significant gain from mean J12.4 to J2.1 (J7-J1) (P <.001). Preoperative uncorrected mean distance visual acuity improved from 0.72 ( ) to 0.82 ( ) postoperatively. One-year results revealed a stable uncorrected near visual acuity (UNVA) with statistically significant gain from mean J12.4 to J2.1 (J7-J1) (P <.001). Preoperative uncorrected mean distance visual acuity improved from 0.72 ( ) to 0.82 ( ) postoperatively. This new femtosecond laser-based treatment shows stable refractive outcomes and 90% patient satisfaction in presbyopia correction. This new femtosecond laser-based treatment shows stable refractive outcomes and 90% patient satisfaction in presbyopia correction.

Result Treated nearly 2,000 eyes with INTRACOR 282 of which have at least 6 months follow-up 214 of which have at least 12 months follow- up 94 of which have at least 24 months’ follow- up

No perioperative or postoperative complications are described. No perioperative or postoperative complications are described. In the Ruiz et al. study, all patients complained of halos starting the day after the surgery but the symptoms improved with time and at 12 months, only 3% of patients reported halos. The only reported complication was decentration Intrastromal femtosecond incisions should be used cautiously in eyes previously treated by LASIK because the predictability of this technique is not currently known. Intracor

CE study Performed at 4 sites in Germany between July and October 2008, the prospective INTRACOR® Conformite Europeenne (CE) study included 63 patients aged 55.4 ±6.2 years (range: years), aged 55.4 ±6.2 years (range: years), with only the non-dominant eye being treated. with only the non-dominant eye being treated. 2-year follow-up data are available for these patients. 2-year follow-up data are available for these patients.

Pre-operative manifest refraction was mean sphere +0.74D ± 0.37, cylinder -0.29D ± 0.24, cylinder -0.29D ± 0.24, uncorrected near visual acuity (UNVA) 0.72 ± 0.17 logMAR, uncorrected near visual acuity (UNVA) 0.72 ± 0.17 logMAR, uncorrected distance visual acuity (UDVA) 0.13 ± 0.11 logMAR, and Best corrected visual acuity (BCVA) 0.01 ± 0.08 logMAR. Post-operative follow-up visits were at 1 day, 1 week, and at months 1, 3, 6, 12 and 24. Post-operative follow-up visits were at 1 day, 1 week, and at months 1, 3, 6, 12 and 24. CE study

Regarding visual outcomes, there was a significant increase in UNVA over time from 0.72 logMAR (20/100) preoperatively to 0.21 logMAR (20/30) Was stable up to 2 years, with similar improvements being seen in distance corrected near visual acuity (CNVA) from 0.60 logMAR (20/80) to 0.19 logMAR(20/28) over the same period. Was stable up to 2 years, with similar improvements being seen in distance corrected near visual acuity (CNVA) from 0.60 logMAR (20/80) to 0.19 logMAR(20/28) over the same period. CE study

The majority of patients gained 4 to 5 lines of near visual acuity while 29% gained 6 lines after the INTRACOR® procedure. Others gained from just 1 or 2 lines to as many as 9 lines of UNVA, with similar changes being seen in lines of DCNV. Approximately 85% of patients were able to achieve 20/40 cumulative UNVA on an ETDRS chart at 40 cm, which is equivalent to seeing newspaper letter size. Similarly, around 86% of patients achieved a cumulative DCNVA level of 20/40. However UDVA and BCDVA remained unchanged up to 24 months. There was a mean myopic shift in manifest spherical equivalent (SE) of up to 0.50D after 24 months. CE study

Glare and Halos or Driving at night? The reason we are bringing up these problems of glare and halos may be because we tend to associate the principle of INTRACOR™ to be similar with some of these multifocal IOLs which uses diffraction rings. INTRACOR™ procedure is not based on diffraction rings; it is actually changing the shape of the cornea and making it slightly more hyper-prolate, as a way of correcting for presbyopia.

Technique usually consists of performing bilateral INTRACOR Followed by phacoemulsification of the CLEAR crystalline lens 1 or 2 weeks later to correct the refractive error. We implant toric and/or spherical IOLs with this combined procedure. The results for INTRACOR before phaco surgery in 24 eyes of 13 patients

Use standard formulas (SRK-T, Haigis, HofferQ, or Holladay) KR and biometry data prior to INTRACOR Preoperative data Mean spherical refractive error, Mean spherical refractive error, Mean cylindrical refractive error Mean cylindrical refractive error Mean distance UCVA, 20/200; Mean distance UCVA, 20/200; Mean near UCVA, 20/60 (J7). Mean near UCVA, 20/60 (J7).

POD= 4 mo Mean data were: Distance UCVA, 20/25 20/20 (53.3%) Distance UCVA, 20/25 20/20 (53.3%) 40% of patients had a near UCVA J1 40% of patients had a near UCVA J1 59.9% J2 59.9% J2 Of the 13 treated patients, 90% resumed their normal activities within 2 weeks postoperatively The level of satisfaction with the result of the procedure was high in most patients.

No patient who underwent INTRACOR followed by phacoemulsification required glasses for distance vision or to read a newspaper. In good light, 95% were able to read J2. There were no significant refractive surprises No IOLs that required lens exchange And no retreatments required for residual refractive errors.

IOL calculation Will not be affected since we usually take the K readings at about 4 mm. We perform a normal calculation with the pre- and post-K values and they are similar

The criteria for pseudophakic presbyopic patients included BCDVA of at least 20/50 or better, Stable distance refraction for the past 6 months, A clear central cornea, An endothelial cell density of ≥2,500 cells/mm2 Patients must have undergone cataract surgery more than 6 months previously. INTRACOR® treatment in monofocal pseudophakic presbyopia

Range -0.75D to +0.25D) preoperatively to a mean of -0.52D (range -0.75D to -0.25D) After one week. Uncorrected distance vision was relatively unchanged throughout the 6 months of follow-up, while UCNVA (Jaeger) showed a dramatic improvement from a preoperative mean of J7.25 (range: J10 to J6) to J2.50 (range: J3 to J2) 1 month postoperatively, a gain of approximately 5 lines of vision which remained stable for 6 months.

Following the INTRACOR procedure, The MRSE went from near plano (mean D, At various distances, overall distance vision is maintained after surgery, But near vision is improved dramatically at 1 meter, 50 cm and at 40 cm INTRACOR® treatment in monofocal pseudophakic presbyopia

Strategy for INTRACOR™ re- treatment Dr Ruiz: We make adjustments to the nomogram which include many factors, such as The number and depth of the rings, The number and depth of the rings, The optical zone, The optical zone, The distance between the rings, etc. The distance between the rings, etc.

Post IntraCor Ectasia Anterior segment OCT

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