smile for hyperopia successful pilot and first study outcomes...©dz reinstein 2016...
TRANSCRIPT
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
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
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
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
First Hyperopic SMILE: 22 May 2014
Kishore Pradhan, MD
Kathmandu, Nepal
©DZ Reinstein 2016
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
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
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
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
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
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
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