in the name of god intrastromal femtosecond incision ( intracor) seyed javad hashemian md eye...
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In the name of GOD
Intrastromal Femtosecond Incision( Intracor)
Seyed Javad Hashemian MD Eye Research Center
Rassoul Akram HospitalTUMS
No financial [email protected]
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 …
Favorab
le 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
Multi- and bi-focals contact lenses & spectacles Monovision
Surgical solutions: IOLs: Multifocal refractive and diffractive and accommodative concepts Scleral methods: Relaxating incisions, Implants Lens manipulations to increase accommodation
Corneal solutions: Monovision based refractive correction Corneal Inlay
Refractive inlays, pinhole inlays ; KAMRA Inlay
INTRACOR Conductive keratoplasty Presbyopic LASIK
Supracor
Presbyopia solutionsA 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),
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 amountof optical aberrations (here positive spherical aberration), the depth offocus 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
IntracorThe 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.
The Intracor
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
So this is a procedure for correcting presbyopia in mild hyperopic patients with normal distance vision.
Intracor
IntracorIt 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.
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
IntracorPreliminary 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.
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,
Dilated fundus examination.
Topography (Tomography; Orbscan II,Intracalc)
Ultrasound Pachymetry
Wavefront Aberrometry
Endothelial cell counts,
Surgical PearlsDocumented stable refractive error
Realistic expectations –enhance near vision
Best patients –late 40s, hyperopia +0.25 - +1.0 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 +0.25-+1.0DBoth eyes with cc vision >= 0.8No previous surgery, clear medias Exclude keratoconus suspectsStart with mean K-readings at approx. 42.0 and 44.0DMaximal 0.5D difference between cyclo and manifest refractionNear addition of +2.0D neededAngle 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 +0.75 to 1.25 D
For patients with MRSE between 0.50 and 0.75 D,
simulate the myopic shift of -0.50 D (or -0.75 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 -0.50 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
21
SUPRACORSUPRACOR INTRACOR
2 hr Post Op
1 Day Post Op 1 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 (0.10-1.00) to 0.82 (0.40-1.00) postoperatively.
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.
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: 43-72 years),
with only the non-dominant eye being treated.
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,
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.
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.
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, -0.88
Mean cylindrical refractive error -1.92
Mean distance UCVA, 20/200;
Mean near UCVA, 20/60 (J7).
POD= 4 mo
Mean data were:
Distance UCVA, 20/25 20/20 (53.3%)
40% of patients had a near UCVA J1
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
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 -0.13D,
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 optical zone,
The distance between the rings, etc.
Post IntraCor Ectasia Anterior segment OCT
Thank You for Your Attention