smile for hyperopia successful pilot and first study outcomes...©dz reinstein 2016...

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SMILE for hyperopia – successful

pilot and first study outcomes

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

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

Kishore R. Pradhan, MD5

Purushottam Dhungana, MOptom OD FLVC5

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

Walter Sekundo, MD PhD6

Raynan Khan, BSc1

1. London Vision Clinic, London, UK

2. Department of Ophthalmology, Columbia University Medical Centre, New York, USA

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

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

5. Tilganga Institute of Ophthalmology, Kathmandu, Nepal

6. Department of Ophthalmology, Phillips University of Marburg, Germany

©DZ Reinstein 2016

dzr@londonvisionclinic.com

Financial Disclosure

The author (DZ Reinstein) acknowledges a financial

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

Morrison, CO)

The authors (DZ Reinstein, W Sekundo) are consultants for

Carl Zeiss Meditec AG (Jena, Germany)

KR Pradhan has travel expenses paid by Carl Zeiss Meditec

AG (Jena, Germany)

GI Carp has travel expenses paid by Carl Zeiss Meditec AG

(Jena, Germany)

©DZ Reinstein 2016

dzr@londonvisionclinic.com

First Study - Hyperopic FLEx

©DZ Reinstein 2016

dzr@londonvisionclinic.com

Second Study - Hyperopic FLEx

• 9 eyes

• 5.75 mm optical zone

• 2.00 mm transition zone

• Achieved a larger optical zone than initial study

©DZ Reinstein 2016

dzr@londonvisionclinic.com

Nepal Trial - Hyperopic SMILE

• Phase I – 4 blind eyes (≥20/200)

• Phase II – 6 densely amblyopic eyes (20/100-20/200)

• Phase III – 10 mildly amblyopic eyes (20/40-20/80)

• Phase IV – 200 sighted eyes

Tilganga Institute of

Ophthalmology Kathmandu, Nepal

• Feasibility study

• Optimize energy settings for easy

lenticule extraction

• Evaluate new lenticule geometry

and achieved optical zone

• Evaluate centration

©DZ Reinstein 2016

dzr@londonvisionclinic.com

First Hyperopic SMILE: 22 May 2014

Kishore Pradhan, MD

Kathmandu, Nepal

©DZ Reinstein 2016

dzr@londonvisionclinic.com

Hyperopic SMILE Lenticule Geometry

• 6.3-6.7 mm Optical Zone

• 90° Lenticule Sidecut

• 8.80 mm Cap Diameter

• Reserve 2mm Small Incision

• 2 mm Small Incision

• 120 µm Cap Thickness

• 2.00 mm Transition Zone

• 30 µm Minimum Thickness

• 0.25 mm Clearance

©DZ Reinstein 2016

dzr@londonvisionclinic.com

Hyperopic SMILE – Dan Reinstein

©DZ Reinstein 2016

dzr@londonvisionclinic.com

Hyperopic SMILE Population

SMILE LASIK LASIK

Planned OZ 6.3-6.7 mm 6.5 mm 7.0 mm

Eyes 60 60 60

SEQ Treated (D) +5.66±0.90

+3.20 to +6.50

+4.83±0.80

+3.13 to +6.30

+5.54±0.95

+3.13 to +7.00

Cyl Treated (D) 1.09±0.71

0.00 to 2.75

0.93±0.71

0.00 to 2.75

1.00±0.73

0.00 to 2.75

Age 29±7

19 to 52

52±13

21 to 72

45±14

20 to 69

CDVA 20/40 or worse 20/40 or better 20/40 or better

Follow-up 3 months 3 months 3 months

©DZ Reinstein 2016

dzr@londonvisionclinic.com

Centration – SMILE vs LASIK

N=58, mean SEQ +5.58 D N=58, mean SEQ +5.54 D

SMILE 7mm LASIK

Offset:

0.23±0.15

Offset:

0.31±0.19

P=0.009

Offset magnitude slightly less for

SMILE than LASIK

©DZ Reinstein 2016

dzr@londonvisionclinic.com

Optical Zone Diameter – SMILE vs LASIK S

MIL

E

6.3

mm

ME

L80

7m

m

ME

L80

6.5

mm

Achieved zone larger for

6.3-6.7 mm SMILE than 7.0 mm LASIK

©DZ Reinstein 2016

dzr@londonvisionclinic.com

Spherical Aberration – SMILE vs LASIK

Spherical aberration induced similar for

6.3-6.7 mm SMILE and 7.0 mm LASIK

P=0.32

©DZ Reinstein 2016

dzr@londonvisionclinic.com

Hyperopic SMILE Population – Sighted Eyes

SMILE LASIK

Eyes 31 93

SEQ Treated (D) +5.73±0.80

+3.38 to +6.50

+5.74±0.80

+3.13 to +6.50

Cyl Treated (D) 1.15±0.82

0.00 to 2.75

1.13±0.80

0.00 to 3.25

Age 28±6

21 to 50

38±6

21 to 76

CDVA 20/40 or better 20/40 or better

Follow-up 3 months 3 months

3-to-1 matched for sphere and cylinder (±0.50 D)

©DZ Reinstein 2016

dzr@londonvisionclinic.com

Outcomes – Sighted Eyes – Efficacy

©DZ Reinstein 2016

dzr@londonvisionclinic.com

Outcomes – Sighted Eyes – Efficacy

LASIK

©DZ Reinstein 2016

dzr@londonvisionclinic.com

Outcomes – Sighted Eyes – Safety

LASIK

©DZ Reinstein 2016

dzr@londonvisionclinic.com

Outcomes – Sighted Eyes – Accuracy

LASIK

©DZ Reinstein 2016

dzr@londonvisionclinic.com

Outcomes – Sighted Eyes – Accuracy

LASIK

©DZ Reinstein 2016

dzr@londonvisionclinic.com

Outcomes – Sighted Eyes – Stability

LASIK

©DZ Reinstein 2016

dzr@londonvisionclinic.com

Conclusions

• Hyperopic SMILE is surgically similar to myopic SMILE – So far, dissection no more difficult than myopic cases

• SMILE brings potential advantages to hyperopic correction – Elimination of fluence projection errors

– Elimination of truncation errors

• Centration of hyperopic SMILE was similar to LASIK

• The achieved optical zone was large – a 6.3-6.7 mm SMILE larger than 7 mm LASIK

• Spherical aberration induction for a 6.3-6.7 mm SMILE was similar to 7 mm LASIK

• Refractive and visual outcomes similar to LASIK

SMILE for hyperopia – successful

pilot and first study outcomes

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

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

Kishore R. Pradhan, MD5

Purushottam Dhungana, MOptom OD FLVC5

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

Walter Sekundo, MD PhD6

Raynan Khan, BSc1

1. London Vision Clinic, London, UK

2. Department of Ophthalmology, Columbia University Medical Centre, New York, USA

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

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

5. Tilganga Institute of Ophthalmology, Kathmandu, Nepal

6. Department of Ophthalmology, Phillips University of Marburg, Germany

Thank You

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