TEI GRAND ROUND

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TEI GRAND ROUND

• REFRACTIVE SURGERY
• BIOPTICS AND CORRECTION OF DECENTERED ABLATIONS
• 06 Jul 05

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Bioptics for myopia Case 1
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Case Summary

• 23/Chinese/Female
• No PMHx
• Severe Myopia
• Pre Op

SPH CYL AXIS cVA
OD -20.00 -3.50 15 6/7.5
OS -18.50 -3.50 175 6/9-2
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Case Summary

• Listed for AC PIOL for Myopia
• Rt IOL 28 Jun 04
• Lt IOL 05 Jul 04
• Post IOL Op (3.5 mths)

ucVA SPH CYL AXIS cVA
OD 6/15-2 -1.00 -2.25 30 6/7.52
OS 6/7.5-2 -0.50 -1.50 170 6/7.52
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Case Summary

• Pre op suitability testing for enhancement via
  LASIK
• ECC OD 2700 OS 2500
• Contrast sensitivity N (F.A.C.T)
• Orbscan OD 554 um OS 555um
• 19 Nov 04 Intralase LASIK done for Rt eye
  (-1.70DS/-2.25DC/40)
• Intralase.MPG
• Flap Lifting.MPG

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Case Summary

• Post LASIK (2 months)

ucVA SPH CYL AXIS cVA
OD 6/9 0.25 -0.50 180 6/7.5-2
OS 6/92 -0.50 -0.75 175 6/7.5-2
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Bioptics for Myopia - Case 2
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Case Summary

• Ms N
• 24 year old / Chinese Malaysian / F
• Contact lens intolerant with GPC / Peripheral
  vascularization
• poor LASIK candidate (OD 539mm, OS 506mm)

SPH CYL AXIS cVA
OD -20.00 -2.25 45 6/12
OS -19.00 -3.00 165 6/9
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Case Summary

• Lt AC PIOL with inferior AK
• Rt AC PIOL with inferior AK

ucVA SPH CYL AXIS cVA
OD 6/24 -3.00 -1.50 85 6/92
OS 6/9-2 -0.50 -3.00 10 6/7.52
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Case Summary

• Patient underwent Rt intralase and LASIK

ucVA SPH CYL AXIS cVA
OD 6/9 plano -1.00 150 6/9
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Update on Bioptics
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Bioptics

• Defined as combination of 2 procedures1
• Phakic IOL implantation followed by LASIK to
  correct high degrees of refractive error
• Maximal degree of myopia or hyperopia intended to
  be corrected by the IOL
• Residual refractive error corrected with LASIK
  after 1 3 mths

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Efficacy of PIOL for high myopic

• Artisan PIOL Benedetti et al9
• UCVA gt 20/40 - 83.8 (Myopia -6.75 to 15.5D)
• UCVA gt 20/40 - 68.0 (Myopia -16 to 23D)
• Complications
• Iris atrophy 11.8
• Lens decentration 5.4
• Night glare 6.4
• Mean Endothelial cell loss11 0.87-3.9 (12
  mths) and 0.78 - 5.4 (24 mths)

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Efficacy of PIOL for high myopic

• Comaparsion of PIOL positional stability
  Baumeister et al10
• AC PIOL No Sig. Ant-post mvt
• PC IOL Sig mvt towards crystalline lens
• Optical Axis Rotation
• Nuvita 1.9 degrees
• Artisan 0.6 degrees
• ICL 0.9 degrees
• AC IOL (iris fixated) - Best positional stability

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Contraindications for PIOL

• Contraindications for PIOL
• AC depth lt 3mm
• Endothelial cell counts lt 2000
• Previous lens opacities
• Ant segment pathologies

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Limitations of individual modalities

• LASIK for high myopics (gt-12.0D)
• Limited corrective magnitude dependent on corneal
  thickness
• Increased level of side effects secondary to
  increased corneal depth ablation
• PIOL
• IOL decentration and displacement
• Cataract formation
• Pupillary block glaucoma
• Inflammatory lens precipitates
• Anterior Chamber (Uveitis Glaucoma Hyphema
  Syndrome, Endothelial decompensation)

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Bioptics

• Key Advantages
• Utilises best of both worlds
• Increases possible range of surgical correction
  for myopia and hyperopia with decreased side
  effects
• Good predictability with LASIK
• Better functional vision post LASIK
• Key Disadvantages
• Staged - Interval between surgeries
• 2 separate procedures hence increase surgical
  risk
• Complications related to PIOL
• Complications related to LASIK

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Evolution of Bioptics

• Described by Roberto Zaldivar2,4,5
• In 1988, he used AC PIOLs (Angle Fixated) alone.
• Baikoff or Nuvita Lens.
• Many AC PIOL related complications

Specific AC PIOL (Angle Fixated) related Cx 3 Specific AC PIOL (Angle Fixated) related Cx 3
Event Cause
Endothelial Cell Loss Intermittent endothelial touch
Pupillary ovalization Iris tuck or oversized IOL Iris root ischemia
Halos and Glare Small optic zones
Iris depigmentation Iris protusion during Sx
Surgically induced astigmatism Long incisions
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Evolution of Bioptics

• In 1996, Zaldivar pioneered bioptics technique. 2
• PC instead of AC PIOL (STAAR AG ICL)
• Combination follow on of LASIK after PC PIOLs
• PC considered better site vs AC 4,5
• Risk of endothelial damage minimised
• Fewer incidences of Halos or glares
• However, key specific disadvs were noted 4,5
• Decentration
• Risk of cataractogenesis PCO formation
• Pupillary block glaucoma

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Evolution of Bioptics

• Jose Guell modified the bioptics technique6
• Termed ARS approach
• Utilises AC PIOL but IRIS fixated
• Artisan non-toric lens
• LASIK flap performed before IOL implantation
• 6mm optical zone for both procedures7
• Key specific advantages vs PC IOL
• Endothelial-IOL contact during microkeratome pass
  avoided8
• No potential risk of PC PIOL dislocation during
  suction

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Comparsion of PC vs AC PIOL1
STAAR ICL (4th Gen) Artisan IOL (Iris Fixated)
No of Eyes 67 26
Follow up 3mth(1d to 6mth) 24mth
Spherical equivalent (Pre op) -23 3.6 (-18.75 to -35) -18.42 2.73 (-16 to -23.5)
Cylinder (Pre Op) 1.5 1.2 ((0 to 5) 13.5 1 ((0 to -4)
UCVA ( Pre Op) lt 20/200 lt 20/200
Spherical equivalent (Pre LASIK) -6 2.8 (-2 to -14.38) -3.65 1.62 (-1.75 to -6.5)
Cylinder (Pre LASIK) -1.5 1.1 (0 to 5) -1.15 0.79 (0 to -3)
Spherical equivalent (Post LASIK) -0.2 0.9 (1.75 to 5.13) -0.38 0.65 (1 to -1)
Cylinder (Post LASIK) -0.5 0.5 (0 to - 2.25) -0.66 0.66 (0 to - 3)
/- 1D emmetropia (Post LASIK) 85 100
/- 0.5D emmetropia (Post LASIK) 67 80.7
UCVA gt 20/40 (Post LASIK) 69 77
Gain gt 2 lines of BSCVA (Post LASIK) 76 42
Loss gt 2 lines of BSCVA (Post LASIK) 0 0
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Suggested choice for each Patient

• Myopia -9.0 to -12.0D LASIK
• Myopia -12.0D to -15.0D Phakic IOL implantation
• Myopia gt 15.0D Bioptics
• More than 50yrs or early lens opacification
  Lens extraction with LASIK for residual
  refractive error

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In the pipeline

• Toric AC PIOL lens12
• Mean post op astigmatism 0.56D/ Axis 31 degrees
• 6 mnth follow up No significant rotation
  observed
• LASEK with AC PIOL13
• Murta et al used LASEK as an alternative to LASIK
• 32 eyes in 18 patients
• Mean Pre Op SE -16.2D
• Artisan AC PIOL followed by LASEK 2-3 mths later
• 90 1D emmetropia 71.9 0.5 D emmetropia
• LASEK Cx Epi Defect 1st POD 72 Grd 1 haze
  12.5
• Implications Alternative for LASIK incompatible
• Intralase for LASIK flap creation

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References

1. Guell, Vazquez. Bioptics, Int Ophth Clin, Summ
   2000.
2. Zaldivar, Oscherow, Ricur. The STAAR Posterior
   Chamber Phakic Intraocular lens. Int Ophth Clin,
   Summ 2000.
3. Zaldivar, Oscherow, Ricur. Implantable contact
   lens. In Clear corneal lens surgery. Thorofare,
   NJ SLACK, 1999.
4. Zaldivar, Davidorf, Oscherow. Combined posterior
   chamber phakic intraocular lens and laser in stu
   keratomileusis bioptics for extreme myopia. J
   Refract Surg 1999.
5. Zaldivar, Davidorf, oscherow. Posterior chamber
   phakic intraocular lens for myopia -8 to -19
   diopters. J Refract Surg 1998.
6. Guell JL. The adjustable refractive surgery
   concept (ARS). Letter J Refract Surg 1998.
7. Guell, Vazquez. ARS ( Adjustable Refractive
   Surgery) 6mm Artisan lens plus LASIK for
   correction of high myopia. AAO meeting Orlando,
   Oct 99.
8. Endothelial study of iris claw phakic lens four
   year follow up. J Refract Surg 98.
9. Benedetti, Casamenti, Marcaccio. Correction of
   myopia of 7 to 24 dioptres with artisan phakic
   intraocular lens 2 yr follow up. J Refract Surg
   2005
10. Baumeister, Buhren, Kohnen. Position of angle
    supported, iris fixated and cilary sulcus
    implanted myopic PIOL evaluated by Scheimpflug
    photography
11. Pop M, Payette. Initial results of ECC after
    artisan lens for phakic eyes. Ophthalmology Feb
    2004
12. Tehrani. Postoperative astigmatism and rotational
    stability after artisan toric phakic IOL
    implantation. J Cataaract Refract Surg Sep 2003
13. Murta et al. Artisan phakic IOL implantation
    followed by LASEK. 7th ESCRS Winter Refractive
    Surgery Meeting.

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• Ms T
• 32 year old / Chinese / Malaysian / F
• Originally bilateral high myope of approximately
  16D.
• OD conventional PRK 1 month previously in Kuala
  Lumpur
• 4 days later, OS clear-lens extraction aphakic

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• Refraction at presentation
• OD -4.00/-1.50 x 50 6/15
• OS 0.75/-1.50 x 180 6/12
• OD decentered ablation complicated by anterior
  basement membrane dystrophy with subepithelial
  scarring.

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OD post-op corneal topo

• OD superior decentration of central ablation
  zone. Central visual axis is undercorrected with
  resultant lower and higher order aberrations.
• Clinically, pt c/o starburst effect and
  increasing anisometropia
• Rx? Prevention, miotics, RGP lenses
• Enhancement, wave-front / topography guided

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Wavefront assessment

• Undilated 8.37/-1.53 x 97, pupil size 4.85
• Dilated 7.44/2.76 x 17
• (least amount of higher order aberrations)

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• Post-wavefront PTK correction
• UCVA 6/7.5
• Refraction plano / -0.50 6/6

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Post-PRK / LASIK decentration

• PRK centration accurate to within 1.0 mm in over
  92 of cases and visual acuity is relatively
  preserved despite deviations from perfect
  centration

Topographical analysis of the centration of
excimer laser photorefractive keratectomy.
Cavanaugh TB, Durrie DS, Riedel SM, Hunkeler JD,
Lesher MP. J Cataract Refract Surg. 199319
Suppl136-43.
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• Centration of keratorefractive procedures from
  the pupil is important and influences lower /
  higher order aberrations.
• Centration was measured more accurately from the
  pupillary center (0.40 mm) than from the corneal
  vertex (0.44 mm).

Centration of excimer laser photorefractive
keratectomy relative to the pupil. Cavanaugh TB,
Durrie DS, Riedel SM, Hunkeler JD, Lesher MP. J
Cataract Refract Surg. 199319 Suppl144-8.
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Conventional PTK for decentered ablations

• repeat PTK using technique where a circle of
  adherent epithelium overlying the decentered
  ablation served as a mask.

Retreatment of decentered excimer photorefractive
keratectomy ablations. Lim-Bon-Siong R, Williams
JM, Steinert RF, Pepose JS. Am J Ophthalmol. 1997
Jan123(1)122-4. Diametral ablation--a
technique to manage decentered photorefractive
keratectomy for myopia. Alkara N, Genth U, Seiler
T. J Refract Surg. 1999 Jul-Aug15(4)436-40.
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Wave-front guided LASIK / PTK

• Achievement of reduction in refractive cylinder,
  increase in uncorrected visual acuity, and
  improved corneal regularity in the majority of
  patients with severe corneal irregularities e.g.
  decentered / small optical zones after LASIK or
  irregular astigmatism after keratoplasty /
  trauma. Poorer results in small irregularities
  e.g. central islands.

Topographically-guided laser in situ
keratomileusis to treat corneal irregularities.
Knorz MC, Jendritza B. Ophthalmology. 2000
Jun107(6)1138-43. Selective zonal ablations
with excimer laser for correction of irregular
astigmatism induced by refractive surgery. Alio
JL, Artola A, Rodriguez-Mier FA. Ophthalmology.
2000 Apr107(4)662-73. Early clinical
experience using custom excimer laser ablations
to treat irregular astigmatism. Tamayo Fernandez
GE, Serrano MG. J Cataract Refract Surg. 2000
Oct26(10)1442-50.
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Topography-guided wave-front for scarred /
extremely irregular corneas

• combination of topographic data with computer
  controlled flying-spot excimer laser ablation was
  suitable for correcting irregular astigmatism
  after significant (gt1mm) postmyopic PRK
  decentrations.

Topography-driven excimer laser for the
retreatment of decentralized myopic
photorefractive keratectomy. Alessio G, Boscia F,
La Tegola MG, Sborgia C. Ophthalmology. 2001
Sep108(9)1695-703. Topographically supported
customized ablation for the management of
decentered laser in situ keratomileusis. Kymionis
GD, Panagopoulou SI, Aslanides IM, Plainis S,
Astyrakakis N, Pallikaris IG. Am J Ophthalmol.
2004 May137(5)806-11. Aberration-sensing and
wavefront-guided laser in situ keratomileusis
management of decentered ablation. Mrochen M,
Krueger RR, Bueeler M, Seiler T. J Refract Surg.
2002 Jul-Aug18(4)418-29.
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Higher-order aberrations?

• Total and higher-order RMS aberrations decreased
  by 40 - 45, after C-CAP treatment.
• Topography-driven C-CAP method is effective in
  post-surgical decentration to enhance the overall
  quality of vision, reduce patient-perceived
  visual aberrations, regularize the corneal
  surface, and maximize BCVA.

Custom-contoured ablation pattern method for the
treatment of decentered laser ablations. Lin DY,
Manche EE. J Cataract Refract Surg. 2004
Aug30(8)1675-84.
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• Thank you

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Specs. of Artisan Myopic lens
Lens type AC AC
Lens Style Iridoplastic bridge Iridoplastic bridge
Lens material UV absorbing C.Q UV absorbing C.Q
Construction One piece compression molded to obtain a lens with superflexible claws One piece compression molded to obtain a lens with superflexible claws
Fixation Midperipheral iris stromal support Midperipheral iris stromal support
Sterilization Ethylene oxide Ethylene oxide
Overall diameter 8.5mm 8.5mm
Optic diameter 5 mm 6 mm
Total lens width 5 mm 6 mm
Total height 0.95 mm 0.95 mm
Weight in air 10 mg (-15 D lens) 15 mg (-15 D lens)
Available powers -3D to -23.5D -3D to -15.5D