Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient...

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Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA) 1 Dan Z Reinstein MD MA(Cantab) FRCSC DABO FRCOphth FEBO 1,2,3,4 1. London Vision Clinic, London, UK 2. Columbia University Medical Center, New York, USA 3. Centre Hospitalier National d’Ophtalmologie, (Pr. Laroche), Paris, France 4. Biomedical Science Research Institute, Ulster University, Coleraine, UK

Transcript of Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient...

Page 1: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

Preoperative assessment, patient selection and

treatment planning for a SMILE patient

Glenn I Carp, MBBCh, FC Ophth (SA)1

Dan Z Reinstein MD MA(Cantab) FRCSC DABO FRCOphth FEBO1,2,3,4

1. London Vision Clinic, London, UK

2. Columbia University Medical Center, New York, USA

3. Centre Hospitalier National d’Ophtalmologie, (Pr. Laroche), Paris, France

4. Biomedical Science Research Institute, Ulster University, Coleraine, UK

Page 2: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

[email protected]

Financial Disclosure

The author (DZ Reinstein) acknowledges a financial

interest in Artemis™ VHF digital ultrasound (ArcScan Inc.,

Morrison, CO)

GI Carp has travel expenses paid by Carl Zeiss Meditec AG

(Jena, Germany)

The author DZ Reinstein is a consultant for Carl Zeiss

Meditec AG (Jena, Germany)

Page 3: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

Ectasia after SMILE?

Page 4: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

[email protected]

Ectasia cases reported after SMILE

Page 5: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

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Ectasia cases reported after SMILE

Page 6: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

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Ectasia cases reported after SMILE

QS: Blinking

Page 7: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

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Ectasia cases reported after SMILE

Inferior Steepening No Inferior Steepening

Eccentric back surface

apex and pachymetry

Epithelial thickness map?

Page 8: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

Ectasia after SMILE?

Page 9: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

SMILE is Still Tissue

Subtraction

Page 10: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

Reasons to offer LASIK

instead of SMILE

PRESBYOND Demanding Patient

Needs good vision in early

postop period

Corneal Scar

Can have LASIK as

lock & key

Page 11: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

Treatment Planning for SMILE

Parameters

Page 12: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

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• Reserve 2mm Small Incision

ReLEx SMILE: Lenticule Geometry

Temporal Nasal

• 6-7.5 mm Optical Zone

• 2 mm Small Incision

• 90° Lenticule Sidecut

• 8 mm Cap Diameter

• 135 µm cap thickness

Page 13: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

[email protected]

• Reserve 2mm Small Incision

ReLEx SMILE: Lenticule Geometry

Temporal Nasal

• 6-7.5 mm Optical Zone

• 2 mm Small Incision

• 90° Lenticule Sidecut

• 8 mm Cap Diameter

• 135 µm cap thickness

Page 14: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

Advantages of a thick cap

Biomechanics Innervation Retreatment

Page 15: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

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Anterior Stroma Stronger than Posterior

Cohesive Tensile Strength Tangential Tensile Strength

Page 16: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

Biomechanics Retreatment

Advantages of a thick cap

Innervation

Page 17: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

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SMILE Cuts Fewer Anterior Nerves

SMILE

LASIK

Page 18: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

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Dry Eye Publications after SMILE • Reinstein DZ, Archer TJ, Gobbe M, Bartoli E. Corneal Sensitivity after Small Incision Lenticule Extraction (SMILE). J Cataract

Refract Surg. 2015 [In Press].

• Wei S, Wang Y. Comparison of corneal sensitivity between FS-LASIK and femtosecond lenticule extraction (ReLEx flex) or small-

incision lenticule extraction (ReLEx smile) for myopic eyes. Graefes Arch Clin Exp Ophthalmol. 2013;251:1645-1654.

• Wei SS, Wang Y, Geng WL, Jin Y, Zuo T, Wang L, Wu D. [Early outcomes of corneal sensitivity changes after small incision

lenticule extraction and femtosecond lenticule extraction]. Zhonghua Yan Ke Za Zhi. 2013;49:299-304.

• Vestergaard AH, Gronbech KT, Grauslund J, Ivarsen AR, Hjortdal JO. Subbasal nerve morphology, corneal sensation, and tear

film evaluation after refractive femtosecond laser lenticule extraction. Graefes Arch Clin Exp Ophthalmol. 2013;251:2591-2600.

• Demirok A, Ozgurhan EB, Agca A, Kara N, Bozkurt E, Cankaya KI, Yilmaz OF. Corneal sensation after corneal refractive surgery

with small incision lenticule extraction. Optom Vis Sci. 2013;90:1040-1047.

• Li M, Zhao J, Shen Y, Li T, He L, Xu H, Yu Y, Zhou X. Comparison of Dry Eye and Corneal Sensitivity between Small Incision

Lenticule Extraction and Femtosecond LASIK for Myopia. PLoS One. 2013;8:e77797.

• Li M, Zhou Z, Shen Y, Knorz MC, Gong L, Zhou X. Comparison of corneal sensation between small incision lenticule extraction

(SMILE) and femtosecond laser-assisted LASIK for myopia. J Refract Surg. 2014;30:94-100.

• Li M, Niu L, Qin B, Zhou Z, Ni K, Le Q, Xiang J, Wei A, Ma W, Zhou X. Confocal Comparison of Corneal Reinnervation after Small

Incision Lenticule Extraction (SMILE) and Femtosecond Laser In Situ Keratomileusis (FS-LASIK). PLoS One. 2013;8:e81435.

• Gao S, Li S, Liu L, Wang Y, Ding H, Li L, Zhong X. Early changes in ocular surface and tear inflammatory mediators after small-

incision lenticule extraction and femtosecond laser-assisted laser in situ keratomileusis. PLoS One. 2014;9:e107370.

• Ishii R, Shimizu K, Igarashi A, Kobashi H, Kamiya K. Influence of femtosecond lenticule extraction and small incision lenticule

extraction on corneal nerve density and ocular surface: a 1-year prospective, confocal, microscopic study. J Refract Surg.

2015;31:10-15.

• Mohamed-Noriega K, Riau AK, Lwin NC, Chaurasia SS, Tan DT, Mehta JS. Early corneal nerve damage and recovery following

small incision lenticule extraction (SMILE) and laser in situ keratomileusis (LASIK). Invest Ophthalmol Vis Sci. 2014;55:1823-1834.

• Xu Y, Yang Y. Dry eye after small incision lenticule extraction and LASIK for myopia. J Refract Surg. 2014;30:186-190.

• Denoyer A, Landman E, Trinh L, Faure J, Auclin F, Baudouin C. Dry eye disease after refractive surgery: comparative outcomes of

small incision lenticule extraction versus LASIK. Ophthalmology. 2015;122(4):669-676

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©DZ Reinstein 2016

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Corneal Sensation: SMILE vs. LASIK

0

10

20

30

40

50

60

-1 0 1 2 3 4 5 6 7 8 9 10 11 12

Me

an

Co

rne

al S

en

sa

tio

n (

mm

)

Time Point (Months)

LASIK (16 studies)

SMILE (7 studies)

SMILE (Reinstein)

Reinstein DZ, Archer TJ, Gobbe M, Bartoli E. Corneal Sensitivity after SMILE. J Cataract Refract Surg 2015.

Page 20: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

[email protected] Slide courtesy Dr Mario Nubile

Page 21: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

Biomechanics Innervation

Advantages of a thick cap

Retreatment

Page 22: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

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Epithelium

SMILE Enhancement: Thin Flap LASIK

+18 μm (4SD) = 118 μm

+18 μm (4SD) ≤80 μm

-18 μm (4SD) = 117 μm

Standard SMILE Protocol:

• Use minimum 135 μm cap

• Retreatment as 100 μm flap LASIK

100 μm

135 μm

Posterior Cornea

Page 23: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

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• Reserve 2mm Small Incision

ReLEx SMILE: Lenticule Geometry

Temporal Nasal

• 6-7.5 mm Optical Zone

• 2 mm Small Incision

• 90° Lenticule Sidecut

• 8 mm Cap Diameter

• 135 µm cap thickness

Page 24: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

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Optical Zone – Ablation/Lenticule Depth

SMILE LASIK

Optical Zone

(mm)

6.70±0.39

(5.90 to 7.00)

6.08±0.22

(5.75 to 7.00)

Ablation/

Lenticule (μm)

107±19

(72 to 149)

81±25

(25 to 134)

5.90 6.00 6.25 6.50 6.75 7.00

SMILE 2% 13% 1% 24% 2% 58%

LASIK 3% 82% 0% 13% 0% 2%

2% 13%

1%

24%

2%

58%

3%

82%

0% 13%

0% 2% 0%

20%

40%

60%

80%

100%

Perc

en

tag

e E

yes

Optical Zone (mm)

+32%

Page 25: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

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Results: Spherical Aberration by OZ

y = -0.0807x - 0.217 R² = 0.7043

y = -0.059x - 0.1811 R² = 0.5357

y = -0.0295x - 0.0968 R² = 0.1816

-0.4

-0.2

0.0

0.2

0.4

0.6

0.8

1.0

1.2

-14.00-12.00-10.00-8.00-6.00-4.00-2.000.00

Ch

an

ge i

n S

ph

eri

cal A

berr

ati

on

(m

icro

ns)

Attempted Spherical Equivalent Refraction (D)

SMILE 6mm

SMILE 6.5mm

SMILE 7mm

Larger Zone Less SA

Page 26: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

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Results: Spherical Aberration Increase

y = -0.0725x - 0.2621 R² = 0.4964

y = -0.0299x + 0.1543 R² = 0.154

-0.30

-0.20

-0.10

0.00

0.10

0.20

0.30

0.40

0.50

0.60

0.70

0.80

-9.00-8.00-7.00-6.00-5.00-4.00-3.00-2.00-1.000.00

Ch

an

ge i

n S

ph

eri

cal A

berr

ati

on

m)

Maximum Myopic Meridian Treated (D)

SMILE

LASIK

p<0.001 SMILE LASIK

Spherical

Aberration

0.11±0.16

(-0.19 to +0.51)

0.31±0.12

(-0.11 to 0.66)

-64%

Page 27: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

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Results: Spherical Aberration by OZ

y = -0.0807x - 0.217 R² = 0.7043

y = -0.059x - 0.1811 R² = 0.5357

y = -0.0295x - 0.0968 R² = 0.1816

y = -0.0606x - 0.015 R² = 0.6601

-0.4

-0.2

0.0

0.2

0.4

0.6

0.8

1.0

1.2

-14.00-12.00-10.00-8.00-6.00-4.00-2.000.00

Ch

an

ge i

n S

ph

eri

cal A

berr

ati

on

(m

icro

ns)

Attempted Spherical Equivalent Refraction (D)

SMILE 6mm

SMILE 6.5mm

SMILE 7mm

LASIK

6mm ‘spherical’ SMILE = 6mm WFO LASIK

but less tissue consumption

6.5mm SMILE Less SA than 6mm WFO LASIK

with equal tissue consumption

7mm SMILE Even less SA

but more tissue consumption than 6mm LASIK

but still leaves the cornea stronger

Larger Zone Less SA

Page 28: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

[email protected]

• Reserve 2mm Small Incision

ReLEx SMILE: Lenticule Geometry

Temporal Nasal

• 6-7.5 mm Optical Zone

• 2 mm Small Incision

• 90° Lenticule Sidecut

• 8 mm Cap Diameter

• 135 µm cap thickness

Page 29: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

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Use 8 mm (7.95) Cap Diameter

• Standardise parameters to minimise effect on nomogram

• Large enough to allow even a 7.5 mm optical zone

• If use Circle retreatment option, the cap is already

reasonably large

Page 30: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

[email protected]

• Reserve 2mm Small Incision

ReLEx SMILE: Lenticule Geometry

Temporal Nasal

• 6-7.5 mm Optical Zone

• 2 mm Small Incision

• 90° Lenticule Sidecut

• 8 mm Cap Diameter

• 135 µm cap thickness

Page 31: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

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Small Incision (and reserve incision)

• 2 mm is sufficient

• We use a supero-temporal incision (and second reserve)

• Others prefer single superior incision

• But difficult to then make a LASIK flap

Temporal Nasal Temporal Nasal

Page 32: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

[email protected]

• Reserve 2mm Small Incision

ReLEx SMILE: Lenticule Geometry

Temporal Nasal

• 6-7.5 mm Optical Zone

• 2 mm Small Incision

• 90° Lenticule Sidecut

• 8 mm Cap Diameter

• 135 µm cap thickness

Page 33: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

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Lenticule Parameters: Minimum Thickness

• Minimum thickness can be reduced to 3 µm to maximize

tissue for refractive correction in high myopia

• Minimum thickness should be increased to make the

lenticule thicker in low myopia, usually 20-25 µm (the

other option is to increase the optical zone diameter)

High Myopia

Low Myopia

Page 34: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

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Femtosecond Energy Settings

2014

2016

Page 35: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

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Lower Femtosecond Energy Levels

Page 36: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

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Lower Femtosecond Energy Levels

Page 37: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

Comparison of Clinical Outcomes and Morphometric Correlation by Scanning

Electron (SEM) and Atomic Force Microscopy (AFM) Between Low and

High Energy SMILE.

David Sung Yong Kang1, Dan Reinstein2, Timothy Archer2, Jin Young Choi1, Byung Jin Ha1, Ji Yong Woo3, Hun Lee3, Tae Im Kim3

1. Eyereum Eye Clinic, Seoul, Korea. 2. London Vision Eye Clinic, Harley Street , London, UK. 2. Institute of Vision Science, Department of Ophthalmology, Yonsei Univ. College of Medicine, Seoul, Korea

D. Reinstein is a consultant to Carl Zeiss and no other author has a financial interest in any of the topics discussed.

Page 38: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

20

19 19

18 18

17 17

18

15

16

17

18

19

20

100 105 110 115 120 130 140 150

Patient Allocation For Each Pulse Energy Group

Energy nJ

n Conventional Energy SMILE

(C-SMILE)

115 nJ

Low Energy SMILE

(L SMILE)

20 30

Page 39: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

Scanning Electron Microscopy Each human lenticule was fixed with 2% glutaraldehyde/paraformaldehyde in 0.1 M phosphate buffered saline, pH 7.4, for 2 hours and washed three times for 30 minutes in 0.1 M PBS. CLs were postfixed for 2 hours with 1% OsO4

dissolved in 0.1 M PBS, dehydrated in a gradually ascending series of ethanol solutions (50-100 %), infiltrated with isoamyl acetate, and dried in a critical point dryer (HCP-2; Hitachi, Tokyo, Japan). Samples were coated with gold by

ion sputter (IB-3 Eiko, Japan) at 6 mA for 6 minutes, and then examined with a scanning electron microscope (FE SEM S-800; Hitachi, Tokyo, Japan) at an acceleration voltage of 10-20 kV and photographed at different magnifications

ranging from 100-10000×. Images were digitalized and stored as tagged image file format files in the microscope computer. SEM examinations were performed for anterior and posterior surfaces of the lenticules (AS-Len and PS-Len)

with each FSL energy group.

5 Diopter Spherical Equivalent Lenticules Obtained For Analysis; 3 From Each Energy

Page 40: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

Atomic Force Microscopy (AFM) Single central area on the lenticule was imaged three times and averaged

Optical center with no forceps manipulation examined

Average Roughness (Ra)

RMS Roughness (Rq)

Ten-Point Mean

Height Roughness (Rz)

Page 41: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1
Page 42: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

Clinical

Correlation

Page 43: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

CONCLUSIONS

Better early postoperative clinical outcomes in L-SMILE group related to

less surface roughness of anterior and posterior lenticule surfaces.

Correlation between smooth optical surfaces and postoperative visual

acuity. Vinciguerra P, Azzolini M, Radice P, et al. A method for examining surface and interface irregularities after photorefractive keratectomy

and laser in situ keratomileusis: predictor of optical and functional outcomes. J Refract Surg 1998;14:S204-6.

Lower FSL energy creates smoother stromal lenticule interface

Higher FSL energy is associated with cavitations and OBL in the

anterior and peripheral cornea where strength is greatest

Using < 115 nJ energy contributes to fast visual recovery without

induction of HOAs in the very early post-operative period in SMILE.

Page 44: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

Recovery technique for SMILE

upper interface

Glenn I Carp MBBCh, FC Ophth (SA)1

Dan Z Reinstein MD MA(Cantab) FRCSC DABO FRCOphth FEBO1,2,3,4

Timothy J Archer MA(Oxon) DipCompSci(Cantab)1

1. London Vision Clinic, London, UK

2. Columbia University Medical Center, New York, NY, USA

3. Centre Hospitalier National d’Ophtalmologie, (Pr. Laroche), Paris, France

4. Biomedical Science Research Institute, Ulster University, Coleraine, Northern Ireland

Page 45: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

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Method: Routine SMILE Surgical Technique

• The routine surgical protocol was to:

– Open the supero-temporal incision

– Delineate the upper and lower lenticule planes

– Separate the upper followed by the lower interface

– Extract the lenticule

Upper Interface Dissected First

Incision

Lenticule

Page 46: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

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• In some cases however:

– Open the supero-temporal incision

– Delineate the upper and lower lenticule planes

– Separate the upper followed by the lower interface

– When attempting separation, the instrument may slip into

the lower interface first…

Method: Recovery Technique

Lower Interface Dissected First

Incision

Lenticule

Page 47: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

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Instrument and Recovery

Real-Time Slow-Motion

Page 48: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

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If the lower interface was dissected

first, recovery can be achieved by:

Upper Interface Recovery Technique

1. Sinskey tip inserted

sideways into the incision

2. Tip rotated upwards to

engage the lenticule edge

3. Tip moved in a nasal

direction to release the

lenticule edge

4. Spatula then able to

dissect the upper interface

Page 49: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

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Results

• This was a retrospective study of 629 consecutive SMILE

eyes of 369 patients, using the VisuMax femtosecond laser

• Upper interface dissected first:

– 555 eyes (305 patients [88%])

– Patients aged 21 to 64 years

– SEQ treated -5.41 D ± 2.43 D (-1.12 to -10.00 D)

– Programmed optical zone diameter 5.85 to 7.50 mm

– Cap thickness 100 to 145 µm

• Lower interface dissected first:

– 74 eyes (64 patients [12%])

– Patients aged 21 to 60 years

– SEQ treated -4.09 D ± 2.00 D (-1.00 to -10.00 D)

– Programmed optical zone diameter 6.00 to 7.50 mm

– Cap thickness 100 to 145 µm

Page 50: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

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Results

Upper Interface: 1.25 Lower Interface: 1.29

Lower Interface: 1.14 Upper Interface: 1.16

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

20/10 20/12.5 20/16 20/20 20/25 20/32 20/40 20/63 20/80 20/100

Cu

mu

lati

ve %

Of

Eyes

Cumulative Snellen VA (20/x or better)

Uncorrected Distance Visual Acuity

Group 1

Group 3

Lower Group

Upper Group

P = 0.24

Upper First Group

Lower First Group

0 1 2 3 4 5

Mean Ease of Dissection

P = 0.07 Easy Hard

Page 51: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

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Conclusion

• During the SMILE procedure, there is a possibility of

inferior plane dissection first

• This has been described previously as a ‘complication’

leading to sometimes aborting the procedure and

switching to PRK or LASIK

• It is possible and relatively easy to rescue the SMILE,

using a recovery technique utilising the sinskey

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Retreatment options after SMILE

Glenn I Carp MBBCh, FC Ophth (SA)1

Dan Z Reinstein MD MA(Cantab) FRCSC DABO FRCOphth FEBO1,2,3,4

Timothy J Archer MA(Oxon) DipCompSci(Cantab)1

1. London Vision Clinic, London, UK

2. Columbia University Medical Center, New York, NY, USA

3. Centre Hospitalier National d’Ophtalmologie, (Pr. Laroche), Paris, France

4. Biomedical Science Research Institute, Ulster University, Coleraine, Northern Ireland

Page 53: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

Retreatment Options After

SMILE

1. PRK

2. Sidecut Only

3. Circle

4. Thin Flap LASIK

5. Sub-cap lenticule extraction

(6. Intrastromal keratotomy)

Off-label

Page 54: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

Retreatment Options After

SMILE

1. PRK

2. Sidecut Only

3. Circle

4. Thin Flap LASIK

5. Sub-cap lenticule extraction

(6. Intrastromal keratotomy)

Off-label

Page 55: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

[email protected]

SMILE Retreatment: PRK

• Brings the disadvantages of PRK

– Slow visual recovery

• 3/12 for the epithelium to remodel fully = Expect a hyperopic shift

– Pain management

– Haze

• ?MMC use, we prefer not to use it

• Can be used as long as final pachymetry >350 μm

Page 56: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

Retreatment Options After

SMILE

1. PRK

2. Sidecut Only

3. Circle

4. Thin Flap LASIK

5. Sub-cap lenticule extraction

(6. Intrastromal keratotomy)

Off-label

Page 57: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

[email protected]

SMILE Retreatment: Sidecut

• Sidecut only converts the cap into a flap

• Easy to lift – equivalent to a regular femtosecond flap

• Flap diameter limited by original cap diameter – 8mm

– Not ideal for excimer ablation centration & transition zone

– Particularly difficult for hyperopic or topography-guided

retreatment

• Forced to have the flap as thick as the cap

Page 58: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

[email protected]

SMILE Retreatment: Sidecut Only

• 1o SMILE: Cap diameter 8 mm, cap thickness 120 μm

• Maximum cap thickness measured as 140 μm by

Artemis VHF digital ultrasound

• Not enough space for safe new flap (70-110 μm gap)

• Sidecut only programmed for 140 μm with 7.7 mm diam.

• TSA ablation performed for -1.00 -0.50 x 5 in 6 mm zone

Postop Cap i.e. incl epi changes

Original Cap i.e. with preop epi

116 μm

Postop Epithelium

140 μm 70 μm 110 μm

Page 59: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

Retreatment Options After

SMILE

1. PRK

2. Sidecut Only

3. Circle

4. Thin Flap LASIK

5. Sub-cap lenticule extraction

(6. Intrastromal keratotomy)

Off-label

Page 60: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

[email protected]

SMILE Retreatment: Circle

• Circle option converts the cap into a flap with a larger

diameter

Page 61: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

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SMILE Retreatment: Sidecut / Circle

• Sidecut and Junction cut easiest to lift

• Also flap bed was undisrupted with smooth transition

between circle interface and original cap interface

Good option for thin

cap SMILE cases

Page 62: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

[email protected]

SMILE Retreatment: Circle

Page 63: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

[email protected]

Circle after SMILE (OD)

Page 64: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

[email protected]

Circle after SMILE (OS)

Page 65: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

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Circle after SMILE

Post SMILE

Post Circle

Page 66: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

Retreatment Options After

SMILE

1. PRK

2. Sidecut Only

3. Circle

4. Thin Flap LASIK

5. Sub-cap lenticule extraction

(6. Intrastromal keratotomy)

Off-label

Page 67: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

[email protected]

SMILE Retreatment: Thin Flap LASIK

• Thin flap creates more superficial sidecut than circle

– Less biomechanical effect + greater residual corneal

strength

• Flap thickness chosen to avoid crossing interfaces

– Bowman's layer (cryptic buttonhole / gas breakthrough)

– SMILE lamellar interface – tricky dissection

Page 68: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

[email protected]

Epithelium

SMILE Retreatment: Thin Flap LASIK

+18 μm (4SD) = 118 μm

+18 μm (4SD) ≤80 μm

-18 μm (4SD) = 117 μm

Standard SMILE Protocol: • Use minimum 135 μm cap (55 epi + 80 Stroma)

• Retreatment as 100 μm flap LASIK

100 μm

135 μm

Posterior Cornea

Page 69: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

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SMILE Retreatment: Thin Flap LASIK

Preop -3.75 -0.75 x 57

SMILE 130 μm cap

1 Yr Postop +1.00 -0.50 x 170

Postop Artemis:

Cap thickness minimum 120 μm

Epithelial thickness maximum 61 μm

90 μm flap LASIK retreatment

(achieves ±20 safety > 4SD)

Page 70: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

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SMILE Retreatment: Thin Flap LASIK

Preop -3.75 -0.75 x 57

SMILE 130 μm cap

1 Yr Post +1.00 -0.50 x 170

LASIK 90 μm flap

1 Day Postop

Page 71: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

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LASIK after SMILE

• Thin flap LASIK

• Ablation then has reached the SMILE interface

LASIK interface

SMILE interface

Page 72: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

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LASIK after SMILE

VHF Digital Ultrasound

OCT

Page 73: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

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SMILE then LASIK vs LASIK then LASIK

• LASIK retreatment introduces risk of epithelial ingrowth

• Primary LASIK (after SMILE) has very, very low risk of

epithelial ingrowth

• SMILE then LASIK actually safer than LASIK then LASIK

Page 74: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

Retreatment Options After

SMILE

1. PRK

2. Sidecut Only

3. Circle

4. Thin Flap LASIK

5. Sub-cap lenticule extraction

(6. Intrastromal keratotomy)

Off-label

Page 75: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

[email protected]

• Use existing SMILE interface

• Only create the lower lenticule interface and sidecut

• Must ensure new lenticule sidecut meets existing cap

– Calculate accurate depth of new lenticule by measuring

epithelial thickening after primary procedure

– OCT / VHF digital ultrasound

Sub-cap-lenticule-extraction

Page 76: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

[email protected]

Sub-cap-lenticule-extraction

Post SMILE

20/63

-1.00 -1.00 x 5

Post SCLE

20/16

+0.50 -0.25 x 150

6.80mm 6.50mm

Page 77: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

Retreatment Options After

SMILE

1. PRK

2. Sidecut Only

3. Circle

4. Thin Flap LASIK

5. Sub-cap lenticule extraction

(6. Intrastromal keratotomy)

Off-label

Page 78: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

©DZ Reinstein 2016

[email protected]

Intrastromal Femto-Keratotomy Incisions

• A future option for very small refractions (where lenticule

would be too thin)

• Intrastromal femto-keratotomy incisions (don’t cross

Bowman’s) – same principal as RK

No loss of tissue

Anterior lamellae

left intact

Page 79: Preoperative assessment, patient selection and treatment ......Preoperative assessment, patient selection and treatment planning for a SMILE patient Glenn I Carp, MBBCh, FC Ophth (SA)1

Preoperative assessment, patient selection and

treatment planning for a SMILE patient

Glenn I Carp, MBBCh, FC Ophth (SA)1

Dan Z Reinstein MD MA(Cantab) FRCSC DABO FRCOphth FEBO1,2,3,4

1. London Vision Clinic, London, UK

2. Columbia University Medical Center, New York, USA

3. Centre Hospitalier National d’Ophtalmologie, (Pr. Laroche), Paris, France

4. Biomedical Science Research Institute, Ulster University, Coleraine, UK

Thank You