SMILE Clinical CompendiumPeer-reviewed journal articles

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Contents

Introduction of SMILE technology 3

Clinical advantages of SMILE 4

Corneal sensitivity and dry eye

Nerve fibre regeneration

Corneal biomechanical stability

Higher order aberrations

Visual outcomes 7

Myopia

Low myopia

Moderate to high myopia

Myopic astigmatism

Comparison with LASIK

Treatment parameters 9

Cap thickness

Energy setting

Laser firing pattern

Optical zone

Incision size

Nomogram

Surgical techniques 10

Pocket irrigation

Alternative surgical techniques

Rescue instruments

SMILE enhancement 10

Possible complications 11

Safety and complications

Suction Loss

Diffuse lamellar keratitis

SMILE and forme fruste keratoconus

Safety related investigations 12

VisuMax laser cut quality and accuracy

Changes to cornea curvature and power

Wound healing/inflammatory response

Effect on endothelial cells

Effect on the ocular posterior segment

Centration accuracy

Experimental applications 14

SMILE and lenticule re-implantation

SMILE with collagen cross linking

SMILE with keratoplasty/keratotomy

Future development 15

Hyperopia correction

3

Small-incision lenticule extraction. Abstract

Journal of Cataract & Refractive Surgery 2015 Mar, Moshirfar M,

McCaughey MV, Reinstein DZ, Shah R, Santiago-Caban L, Fenzl CR

Advances in refractive surgery. Full text

Asia-Pacific Journal of Ophthalmology 2015 Mar, Mysore N

and Krueger R

Small Incision Lenticule Extraction (SMILE) in 2015.

Cornea 2015 Apr, Reinstein DZ Full text

New developments in the lenticule extraction procedure.

US Ophthalmic Review 2014 Apr, Hjortdal J, Ivarsen A Full text

Small incision lenticule extraction (SMILE) history,

fundamentals of a new refractive surgery technique

and clinical outcomes. Full text

Eye and Vision 2014, Reinstein DZ, Archer TJ, Gobbe M

One-year refractive results, contrast sensitivity, high-order

aberrations and complications after myopic small-incision

lenticule extraction (ReLEx SMILE). Abstract

Graefes Archive for Clinical Experimental Ophthalmology

2014 May, Sekundo W, Gertnere J, Bertelmann T, Solomatin I

Efficacy, safety, predictability, contrast sensitivity, and

aberrations after femtosecond laser lenticule extraction.

Journal of Cataract & Refractive Surgery 2014, Vestergaard AH,

Grauslund J, Ivarsen AR, Hjortdal JØ Abstract

Femtosecond laser refractive surgery: small incision lenticule

extraction vs. femtosecond laser-assisted LASIK.

Current Opinion in Ophthalmology 2015 July, Lee JK, Chuck RS,

Park CY Abstract

Introduction of SMILE technology

“The all-femtosecond-based flap-free intracorneal refractive procedure has been documented to be a predictable, efficient, and safe procedure for correction of myopia and astigmatism.”Jesper Hjortdal, Clinical Professor, Department of Ophthalmology, Aarhus University

Hospital, Denmark

“Visual and refractive outcomes and safety have been shown to be similar to LASIK. A number of studies have demonstrated a lower reduction and faster recovery of corneal sensitivity and subbasal nerve fiber density after SMILE than LASIK, as expected since the anterior stroma is disturbed only by the small incision.”Dan Z Reinstein, Medical Director, London Vision Clinic, London, UK

4

Dry eye disease after refractive surgery: comparative

outcomes of small incision lenticule extraction

versus LASIK. Abstract

Ophthalmology 2015 Apr, Denoyer A, Landman E, Trinh L,

Faure JF, Auclin F, Baudouin C

Dry eye after small incision lenticule extraction and LASIK

for myopia. Abstract

Journal of Refractive Surgery 2014 Mar, Xu Y, Yang Y

Comparison of dry eye and corneal sensitivity between

Small Incision Lenticule Extraction and femtosecond LASIK

for myopia. Full text

PLOS one 2013 Oct, Meiyan Li, Jing Zhao, Yang Shen, Tao Li,

Li He, Hailin Xu, Yongfu Yu, and Xingtao Zhou

Corneal sensitivity after small-incision lenticule extraction

and laser in situ keratomileusis. Abstract

Journal of Cataract & Refractive Surgery 2015 Aug,

Reinstein DZ, Archer TJ, Gobbe M, Bartoli E

Comparison of corneal sensitivity between FS-LASIK and

femtosecond lenticule extraction or small-incision lenticule

extraction for myopic eyes. Full text

Graefe’s Archive for Clinical and Experimental Ophthalmology

2013 Oct, Wei S, Wang Y

Early outcomes of corneal sensitivity changes after

small incision lenticule extraction and femtosecond

lenticule extraction. Abstract

Graefe’s Archive for Clinical and Experimental Ophthalmology

2013 Jun, Wei SS, Wang Y, Geng WL, Jin Y, Zuo T, Wang L, Wu D

Influence of femtosecond lenticule extraction and small incision

lenticule extraction on corneal nerve density and ocular surface:

A 1-year prospective, confocal, microscopic study. Abstract

Journal of Refractive Surgery 2015 Jan, Ishii R, Shimizu K,

Igarashi A, Kobashi H, Kamiya K

Central corneal sensitivity after small incision lenticule

extraction versus femtosecond laser-assisted LASIK for

myopia: a meta-analysis of comparative studies. Full text

BioMed Central Opthalmology 2015 April, He M, Huang W, Zhong X

Clinical advantages of SMILE

Corneal sensitivity and dry eye

“The SMILE procedure has a less pronounced impact on the ocular surface and corneal innervation compared with LASIK, further reducing the incidence of dry eye disease and subsequent degradation in quality of life after refractive surgery.”Denoyer et al, Ophthalmology 2015 Apr

“Dry eye after corneal refractive surgery usually occurs transiently. The SMILE procedure had better dry eye parameters (Schirmer secretion test without anesthesia, tear break-up time) and relatively fewer subjective symptoms (the McMonnies questionnaire) than LASIK.”Xu et al, Journal of Refractive Surgery 2014 Mar

5

Influence of Femtosecond Lenticule Extraction and Small

Incision Lenticule Extraction on Corneal Nerve Density

and Ocular Surface: A 1-Year Prospective, Confocal,

Microscopic Study. Abstract Journal of Refractive Surgery

2015 Jan, Ishii R, Shimizu K, Igarashi A, Kobashi H, Kamiya K

Confocal comparison of corneal reinnervation after Small

Incision Lenticule Extraction (SMILE) and Femtosecond

Laser In Situ Keratomileusis (FS-LASIK). Full text

PLOS One 2013 Dec, Meiyan Li, Lingling Niu, Bing Qin,

Zimei Zhou, Katherine Ni, Qihua Le, Jun Xiang, Anji Wei,

Weiping Ma, Xingtao Zhou

Corneal regeneration after femtosecond laser small-

incision lenticule extraction: a prospective study. Abstract

Graefe’s Archive for Clinical and Experimental Ophthalmology 2015

Mar, Liu M, Zhang T, Zhou Y, Sun Y, Wang D, Zheng H, Liu Q

Nerve fibre regeneration

Early corneal nerve damage and recovery following small

incision lenticule extraction (SMILE) and laser in situ

keratomileusis (LASIK). Abstract

Investigative Ophthalmology & Vision Science 2014 Mar, Mohamed-

Noriega K, Riau AK, Lwin NC, Chaurasia SS, Tan DT, Mehta JS

Fellow eye comparison of nerve fiber regeneration after

SMILE and femtosecond laser-assisted LASIK: A confocal

microscopy study. Abstract

Journal of Refractive Surgery 2015 Sep, Agca A, Cankaya KI,

Yilmaz I, Yildirim Y, Yasa D, Olcucu O, Demircan A, Demirok A

Subbasal nerve morphology, corneal sensation, and tear

film evaluation after refractive femtosecond laser

lenticule extraction. Abstract

Graefe’s Archive for Clinical Experimental Ophthalmology 2013 Nov,

Vestergaard AH, Grønbech KT, Grauslund J, Ivarsen AR, Hjortdal JØ

Clinical advantages of SMILE

Comparison of corneal biomechanical characteristics after

surface ablation refractive surgery and novel lamellar

refractive surgery. Abstract

Cornea 2015 Nov, Dou R, Wang Y, Xu L, Wu D, Wu W, Li X

Differences in the corneal biomechanical changes after

SMILE and LASIK. Abstract

Journal of Refractive Surgery 2014 Oct, Wang D, Liu M,

Chen Y, Zhang X, Xu Y, Wang J, To CH, Liu Q

Evaluation of corneal biomechanical properties

modification after small incision lenticule extraction using

Scheimpflug-based noncontact tonometer. Full text

Biomed Research International 2014 Aug, Mastropasqua L,

Calienno R, Lanzini M, Colasante M, Mastropasqua A,

Mattei PA, Nubile M

Corneal biomechanical effects: Small-incision lenticule extraction

versus femtosecond laser–assisted laser in situ keratomileusis.

Journal of Cataract & Refractive Surgery 2014 Jun, Di Wu,

Yan Wang, Lin Zhang, Shengsheng Wei, Xin Tang Abstract

Comparison of biomechanical effects of small incision

lenticule extraction and laser in situ keratomileusis:

finite-element analysis. Abstract

Journal of Refractive Surgery 2014 Jun, Sinha Roy A,

Dupps WJ Jr, Roberts CJ

Mathematical model to compare the relative tensile

strength of the cornea after PRK, LASIK, and Small Incision

Lenticule Extraction. Abstract

Journal of Refractive Surgery 2013 Jul, Reinstein DZ, Archer TJ,

Randleman JB

Corneal biomechanical stability

“Both SMILE and FS-LASIK can cause biomechanical changes in the cornea. However, changes in the cornea’s viscoelastic properties were less after lenticule extraction than after LASIK.” Wu et al, Journal of Cataract & Refractive Surgery 2014 Jun

6

Aberration compensation between anterior and

posterior corneal surfaces after Small incision lenticule

extraction and Femtosecond laserassisted laser in-situ

keratomileusis Abstract

Ophthalmic & Physiological Optic 2015 Jun, Li X, Wang Y, Dou R

Comparison of corneal shape changes and aberrations

induced by FS-LASIK and SMILE for myopia. Abstract

Journal of Refractive Surgery 2015 Apr, Gyldenkerne A,

Ivarsen A, Hjortdal JØ

One-year refractive results, contrast sensitivity, high-order

aberrations and complications after myopic small-incision

lenticule extraction (ReLEx SMILE). Abstract

Graefe’s Archive for Clinical and Experimental Ophthalmology

2014 Mar, Sekundo W, Gertnere J, Bertelmann T, Solomatin I

Statistical characteristics of aberrations of human eyes

after small incision lenticule extraction surgery and

analysis of visual performance with individual eye model.

Applied Optics 2015 Sep, Lou Q, Wang Y, Wang Z, Liu Y,

Zhang L, Fang H Abstract

Postoperative ocular higher-order aberrations and contrast

sensitivity: Femtosecond lenticule extraction versus

pseudo small-incision lenticule extraction.

Journal of Cataract & Refractive Surgery 2015 Mar, Tan DK,

Tay WT, Chan C, Tan DT, Mehta JS Abstract

Optical quality and intraocular scattering after

femtosecond laser small incision lenticule extraction.

Journal of Refractive Surgery 2014 May, Miao H, He L, Shen Y,

Li M, Yu Y, Zhou X Abstract

Clinical advantages of SMILE

Higher order aberrations

“ReLEx® SMILE produced satisfactory refractive outcomes with moderate induction of HOA and unaffected contrast sensitivity after 1 year.”Graefe’s Archive for Clinical Experimental Ophthalmology 2014 Mar

“SMILE and FS-LASIK produced distinct changes in anterior corneal shape evident in different postoperative corneal curvatures and power measurements between the two groups. Postoperative HOAs were much lower after SMILE as compared to FS-LASIK.” Gyldenkerne et al, Journal of Refractive Surgery 2015 Apr

7

Visual outcomes

One-year outcomes of small-incision lenticule extraction

(SMILE): mild to moderate myopia vs. high myopia. Full text

BioMed Central Ophthalmology 2015 Jun, Kim JR, Kim BK, Mun

SJ, Chung YT, Kim HS

One-year results of Small Incision Lenticule Extraction

(SMILE) in myopia. Abstract

Klinische Monatsblätter für Augenheilkunde 2014 Oct,

Kunert KS, Melle J, Sekundo W, Dawczynski J, Blum M

Efficacy, predictability, and safety of small incision lenticule

extraction: 6-months prospective cohort study. Full text

BioMed Central Ophthalmology 2014 Oct, Kim JR, Hwang HB,

Mun SJ, Chung YT, Kim HS

Small-Incision Lenticule Extraction for myopia: Results of

a 12-month prospective study. Full text

Optometry & Vision Science 2014 Nov, Xu Y, Yang Y

Visual and refractive outcomes of femtosecond lenticule

extraction and Small-Incision Lenticule Extraction for myopia.

American Journal of Ophthalmology 2013 Oct, Kamiya K,

Shimizu K, Igarashi A, Kobashi H Abstract

Outcomes of Small Incision Lenticule Extraction (SMILE)

in low myopia. Abstract

Journal of Refractive Surgery 2014 Dec, Reinstein DZ, Carp G

SMILE: Refractive lenticule extraction for myopic correction.

Journal Français D’Ophtalmologie 2015 Mar, Albou-Ganem C,

Lavaud A, Amar R Abstract

“Small incision lenticule extraction for low myopia was found to be safe and effective with outcomes similar to those previously reported for LASIK.”Reinstein et al, Journal of Refractive Surgery 2014 Dec

“SMILE is a predictable and safe technique for the surgical correction of moderate to high myopia.”Albou-Ganem et al, Journal Français D’Ophtalmologie 2015 Mar

Myopia Low myopia

Moderate to high myopia

8

Visual outcomes

Comparison of visual and refractive outcomes following

femtosecond laser assisted LASIK with SMILE in patients

with myopia or myopic astigmatism. Abstract

Journal of Refractive Surgery 2014 Sep, Sri Ganesh, Rishika Gupta

Comparison of the Visual Results After SMILE and

Femtosecond Laser-Assisted LASIK for Myopia. Abstract

Journal of Refractive Surgery 2014 Apr, Lin F, Xu Y, Yang Y

Comparison of small incision lenticule extraction and

femtosecond laser assisted LASIK for myopia.

International Eye Science 2013 Oct, Hu Y-K, Li W-J, Gao X-W,

Guo Y-L, Dong J

Comparison with LASIK

“Three-month results demonstrate that refractive accuracy, dry eye, contrast, and induced aberrations are better following SMILE rather than LASIK.” Ganesh et al, Journal of Refractive Surgery 2014 Sep

“SMILE and FS-LASIK are safe, effective, and predictable surgical procedures to treat myopia. SMILE has a lower induction rate of higher-order aberrations and spherical aberration than the FS-LASIK procedure.”Lin et al, Journal of Refractive Surgery 2014 Apr

Clinical study of femtosecond laser corneal small incision

lenticule extraction for correction of myopia and myopic

astigmatism. Abstract

Chinese Journal of Ophthalmology 2013 Apr, Wang Y, Bao XL,

Tang X, Zuo T, Geng WL, Jin Y

Comparison of astigmatic correction after femtosecond

lenticule extraction and small incision lenticule extraction

for myopic. Full text

PLOS One 2015 Apr, Kobashi H, Kamiya K, Ali MA, Igarashi A,

Elewa ME, Shimizu K

Anterior and Posterior Corneal Astigmatism after Refractive

Lenticule Extraction for Myopic Astigmatism. Full text

Journal of Ophthalmlogy 2015 May, Kamiya K, Shimizu K,

Mayumi Yamagishi, Igarashi A, and Kobashi H

Small incision lenticule extraction (SMILE) procedure for

the correction of myopia and myopic astigmatism.

Journal of Emmetropia 2013 Oct, Verdaguer P, El-Husseiny MA,

Elies D, Gris O, Manero F, Biarnés M, Güell JL Full text

Myopic astigmatism

9

Treatment parameters

Contralateral eye comparison between femtosecond

Small Incision Intrastromal Lenticule Extraction at depths

of 100 and 160μm. Abstract

Cornea 2015 Oct, El-Massry AA, Goweida MB, Shama Ael-S,

Elkhawaga MH, Abdalla MF

SMILE procedures with four different cap thicknesses

for the correction of myopia and myopic astigmatism.

Abstract

Journal of Refractive Surgery 2015 Sep, Güell JL, Verdaguer P,

Mateu-Figueras G, Elies D, Gris O, El Husseiny MA, Manero F, Morral M

”Undercorrection of 0.25 D and small effects of patient age and corneal curvature suggest that the standard nomogram for SMILE need only minor adjustments. This study suggests that safety and efficacy are not influenced to any clinically significant degree by easily discernible patient factors.”Hjortdal et al, Journal of Refractive Surgery 2012 Dec

Cap thickness

Corneal power distribution and functional optical zone

following Small Incision Lenticule Extraction for myopia.

Journal of Refractive Surgery 2015 Aug, Qian Y, Huang J,

Zhou X, Hanna RB Abstract

Two millimeter micro incision lenticule extraction surgery

with minimal invasion: a preliminary clinical report. Abstract

Zhonghua Yan Ke Za Zhi 2014 Sep, Wang Y, Wu Z, Tang X,

Zhang J, Dou R, Geng W, Jin Y, Zuo T

Optical zone

Incision size

Effect of femtosecond laser setting on visual performance

after small-incision lenticule extraction for myopia. Abstract

The British Journal of Ophthalmology 2015 Apr, Kamiya K,

Shimizu K, Igarashi A, H

Effect of different femtosecond laser-firing patterns on

collagen disruption during refractive lenticule extraction.

Journal of Cataract & Refractive Surgery 2012 Aug, Riau AK,

Angunawela RI, Chaurasia SS, Tan DT, Mehta JS Abstract

Predictors for the outcome of Small-incision Lenticule

Extraction for myopia. Abstract

Journal of Refractive Surgery 2012 Dec, Hjortdal JØ,

Vestergaard AH, Ivarsen A, Ragunathan S, Asp S

Vector analysis of low to moderate astigmatism with

small incision lenticule extraction (SMILE): results of a

1-year follow-up. Full text

BioMed Central Ophthalmology 2015 Jan, Zhang J, Wang Y,

Wu W, Xu L, Li X, Dou R

Correction of myopic astigmatism with Small Incision

Lenticule Extraction. Abstract

Journal of Refractive Surgery 2014 Apr, Ivarsen A, Hjortdal J

Energy setting

Laser firing pattern

Nomogram

10

Effect of intraoperative corneal stromal pocket irrigation in

Small Incision Lenticule Extraction. Full text

Biomed Research International 2015 Jul, Liu YC, Jayasinghe L,

Ang HP, Lwin NC, Yam GH, Mehta JS

Preliminary evidence of successful enhancement after

a primary SMILE procedure with the sub-cap-lenticule-

extraction technique. Abstract

Journal of Refractive Surgery 2015 Oct, Donate D, Thaëron R

Comparison of four different VisuMax circle patterns

for flap creation after Small Incision Lenticule Extraction.

Journal of Refractive Surgery 2013 Apr, Riau AK, Ang HP,

Lwin NC, Chaurasia SS, Tan DT, Mehta JS Abstract

Development of the continuous curvilinear lenticulerrhexis

technique for Small Incision Lenticule Extraction. Abstract

Journal of Refractive Surgery 2015 Jan, Zhao Y, Li M, Yao P,

Shah R, Knorz MC, Zhou X

New instruments for Lenticule Extraction in Small

Incision Lenticule Extraction (SMILE). Full text

PLOS One 2014 Dec, Liu YC, Pujara T, Mehta JS

Pocket irrigation

Alternative surgical techniques

Rescue instruments

Surgical techniques

SMILE enhancement

11

Possible complications

Safety and complications of more than 1500 Small-Incision

Lenticule Extraction procedures. Abstract

Ophthalmology 2014, Ivarsen A, Asp S, Hjortdal J

“SMILE had acceptable safety. Although 1.5% of eyes had reduced CDVA by 3 months, visual acuity was restored in the long term. Likewise, patient satisfaction was high.”Ivarsen et al, Ophthalmology 2014

Safety & complications

Incidence and management of suction loss in refractive

lenticule extraction. Abstract

Journal of Cataract & Refractive Surgery 2014 Dec,

Chee Wai Wong, Cordelia Chan, Donald Tan, Jodhbir S. Mehta

Implications and management of suction loss during

Refractive Lenticule Extraction (ReLEx). Abstract

Journal of Refractive Surgery 2013 Jul, Sharma R, Vaddavalli PK

Diffuse lamellar keratitis after small-incision lenticule

extraction. Abstract

Journal of Cataract & Refractive Surgery 2015 Feb, Zhao J,

He L, Yao P, Shen Y, Zhou Z, Miao H, Wang X, Zhou X

Corneal ectasia after femtosecond laser-assisted small-incision

lenticule extraction in eyes with subclinical keratoconus/

forme fruste keratoconus.

Journal of Cataract & Refractive Surgery 2015 Jul, Remy M,

Kohnen T Abstract

Bilateral ectasia after femtosecond laser-assisted small-

incision lenticule extraction. Abstract

Journal of Cataract & Refractive Surgery 2015 Jun, Mastropasqua L

Corneal ectasia 6.5 months after small-incision lenticule

extraction. Abstract

Journal of Cataract & Refractive Surgery 2015 May, Wang Y,

Cui C, Li Z, Tao X, Zhang C, Zhang X, Mu G

Suction loss

Diffuse lamellar keratitis

SMILE and forme fruste keratoconus

12

Safety related investigations

Lenticule thickness readout for Small Incision Lenticule

Extraction compared to Artemis three-dimensional very

high-frequency digital ultrasound stromal measurements.

Journal of Refractive Surgery 2014 May, Reinstein DZ,

Archer TJ, Gobbe M Abstract

The Morphology of corneal cap and its relation to

refractive outcomes in femtosecond laser Small Incision

Lenticule Extraction (SMILE) with anterior segment optical

coherence tomography observation. Full text

PLOS ONE 2013 Aug, Zhao J, Yao P, Li M, Chen Z, Shen Y,

Zhao Z, Zhou Z, Zhou X

Changes to cornea curvature and power

Assessing the corneal power change after refractive

surgery using Scheimpflug imaging. Abstract

Ophthalmic & Physiological Optic 2015 May, Gyldenkerne A,

Ivarsen A, Hjortdal JØ

Surface quality of human corneal lenticules after

SMILE assessed using environmental scanning electron

microscopy. Abstract

Journal of Refractive Surgery 2014 Jun, Ziebarth NM, Lorenzo MA,

Chow J, Cabot F, Spooner GJ, Dishler J, Hjortdal JØ, Yoo SH

Surface quality of human corneal lenticules after

femtosecond laser surgery for myopia comparing different

laser parameters. Full text

Graefe’s Archive for Clinical and Experimental Ophthalmology

2011 Sep, Kunert KS, Blum M, Duncker GI, Sietmann R, Heichel J

Accuracy and reproducibility of cap thickness in Small

Incision Lenticule Extraction. Abstract

Journal of Refractive Surgery 2013 Oct, Reinstein DZ,

Archer TJ, Gobbe M

Accuracy and precision of cap thickness in small incision

lenticule extraction. Full text

Clinical Ophthalmology2013 Jul, Ozgurhan EB, Agca A,

Bozkurt E,Gencer B, Celik U, Cankaya KI,Demirok A, Yilmaz OF

VisuMax laser cut quality and accuracy

“The VisuMax readout lenticule depth was found to be 8μm thicker than the achieved stromal change. This can be partly explained by alignment errors between preoperative and postoperative scans.”Reinstein et al, Journal of Refractive Surgery 2013 Oct

13

Safety related investigations

Optical zone centration accuracy using corneal fixation-

based SMILE compared to eye tracker based femtosecond

laser-assisted LASIK for myopia. Abstract

Journal of Refractive Surgery 2015 Sep, Reinstein DZ, Gobbe M,

Gobbe L, Archer TJ, Carp GI

Topographic analysis of the centration of the treatment

zone after SMILE for myopia and comparison to FS-LASIK:

subjective versus objective alignment. Abstract

Journal of Refractive Surgery 2014 Oct, Lazaridis A,

Droutsas K, Sekundo W

Mild decentration measured by a Scheimpflug camera and

its impact on Visual Quality following SMILE in the early

learning curve. Full text

Investigative Ophthalmology & Vision Science 2014 May, Li M,

Zhao J, Miao H, Shen Y, Sun L, Tian M, Wadium E, Zhou X

Decentration of optical zone center and its impact on

visual outcomes following SMILE. Abstract

Cornea 2015 Apr, Liu M, Sun Y, Wang D, Zhang T, Zhou Y,

Zheng H, Liu Q

Centration accuracy

“The centration of the treatment zone as measured by the Pentacam was better for patient-controlled fixation during SMILE than active eye tracker-assisted FS-LASIK.”Lazaridis et al, Journal of Refractive Surgery 2014 Oct

Wound healing/ inflammatory response

Early changes in ocular surface and tear inflammatory

mediators after small-incision lenticule extraction and

femtosecond laserassisted laser in situ keratomileusis.

PLOS One 2014 Sep, Gao S, Li S, Liu L, Wang Y, Ding H, Li L,

Zhong X Full text

Small incision lenticule extraction (SMILE) and femtosecond

laser LASIK: comparison of corneal wound healing and

inflammation. Full text

The British Journal of Ophthalmology 2013 Nov, Dong Z,

Zhou X, Wu J, Zhang Z, Li T, Zhou Z, Zhang S, Li G

Early corneal wound healing and inflammatory response

after Refractive Lenticule Extraction (ReLEx). Full text

Investigative Ophthalmology & Visual Science 2011 Aug,

Riau A, Angunawela RI, Chaurasia SS, Lee WS, Tan D, Mehta JS

Effect on endothelial cells

Short-term and long-term effects of small incision lenticule

extraction (SMILE) on corneal endothelial cells. Abstract

Contact Lens & Anterior Eye 2015 Apr, Zhang H, Wang Y,

Xie S, Wu D, Wu W, Xu L

Effect on the ocular posterior segment

Effect of suction on macular and retinal nerve fiber layer

thickness during femtosecond lenticule extraction and

femtosecond laser-assisted laser in situ keratomileusis.

Journal of Cataract & Refractive Surgery 2014 Dec, Zhang J,

Zhou Y, Zheng Y, Liu Q, Zhai C., Wang Y Abstract

14

Experimental applications

The safety and predictability of implanting autologous

lenticule obtained by SMILE for hyperopia. Abstract

Journal of Refractive Surgery 2015 Jun, Sun L, Yao P, Li M,

Shen Y, Zhao J, Zhou X

Tailored stromal expansion with a refractive lenticule

for cross-linking the ultrathin cornea. Abstract

Journal of Cataract & Refractive Surgery 2015 May,

Sachdev MS, Gupta D, Sachdev G, Sachdev R

LASIK following Small Incision Lenticule Extraction (SMILE)

lenticule re-implantation: A feasibility study of a novel

method for treatment of presbyopia. Full text

PLOS One 2013 Dec, Lim CHL, Riau AK, Lwin NC, Chaurasia SS,

Tan DT, Mehta JS

Femtosecond laser-assisted keyhole endokeratophakia:

correction of hyperopia by implantation of an allogeneic

lenticule obtained by SMILE from a myopic donor. Abstract

Journal of Refractive Surgery 2013 Nov, Pradhan KR, Reinstein DZ,

Carp GI, Archer TJ, Gobbe M, Gurung R

Reversible femtosecond laser-assisted myopia correction:

A non-human primate study of lenticule re-implantation

after refractive lenticule extraction. Full text

PLOS One 2013 Jun, Riau AK, Angunawela RI, Chaurasia SS,

Lee WS, Tan DT, Mehta JS

Cryopreservation of extracted corneal lenticule after

small incision lenticule extraction for potential use in

human subjects. Full text

Cornea 2014 Dec, Ganesh S, Brar S, Rao PA

Cornea lenticule viability and structural integrity after

refractive lenticule extraction (ReLEx) and cryopreservation.

Mohamed-Noriega K, Toh KP, Poh R, Balehosur D, Riau A,

Htoon HM, Peh GSI, Chaurasia SS, Tan D, Mehta JS Full text

SMILE and lenticule re-implantation

“Based on the initial clinical outcome it appears that SMILE Xtra may be a safe and feasible modality to prevent corneal ectasia in susceptible individuals.”Ganesh et al, Journal of Ophthalmology 2015 Jun

SMILE with collagen cross-linking

Femtosecond intrastromal lenticular implantation

combined with accelerated collagen cross-linking for the

treatment of keratoconus – initial clinical result in 6 eyes.

Cornea 2015 Oct, Ganesh S, Brar S Abstract

Clinical outcomes of Small Incision Lenticule Extraction

with accelerated Cross-Linking (ReLEx SMILE Xtra) in

patients with thin corneas and borderline topography.

Journal of Ophthalmology 2015 Jun, Ganesh S, Brar S Full text

SMILE with keratoplasty/ keratotomy

Small Incision Lenticule Extraction after Deep Anterior

Lamellar Keratoplasty. Abstract

Journal of Refractive Surgery 2015 Sep, Mastropasqua L,

Calienno R, Lanzini M, Nubile M

Full-thickness astigmatic keratotomy combined with

Small-Incision Lenticule Extraction to treat high-level

and mixed astigmatism. Abstract

Cornea 2015 Sep, Kim BK, Mun SJ, Lee DG, Kim JR, Kim HS, Chung YT

15

Future development

Improved lenticule shape for hyperopic femtosecond

lenticule extraction (ReLEx® FLEx): a pilot study. Abstract

Lasers in Medical Science 2016 May, Sekundo W, Reinstein DZ, Blum M

Femtosecond lenticule extraction (ReLEx®) for correction

of hyperopia - first results. Abstract

Graefe’s Archive for Clinical and Experimental Ophthalmology

2013 Jan, Blum M, Kunert KS, Voßmerbäumer U, Sekundo W

Hyperopia correction

“This pilot study confirms that the improved lenticule’s design with a large optical and transition zone can achieve good centration and acceptable results for spherical hyperopia using FLEx.” Sekundo et al, Lasers in Medical Science 2016 May

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Each Publication is based on the author´s own professional opinion or their study results.

It does not necessarily reflect Carl Zeiss Meditec AG’s opinion and may not be in line with the clinical

evaluation or intended purpose of our medical devices. Therefore, suitability of clinical application for each

recommendation should be carefully assessed by the concerned physician.