6/12/2011. SNEC s Experience. Refractive Lenticule Extraction (ReLEx ): The SNEC Experience Do we still need an excimer laser?

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1 // ESCRS Instructional Course, Vienna Refractive Lenticule Extraction (ReLEx ): The SNEC Experience Do we still need an excimer laser? SNEC s Experience Yuen et al. Ophthalmology ():- ; : Professor Donald Tan FRCSE FRCSG FRCOPhth FAMS Director, Singapore National Eye Centre Chairman, Singapore Eye Research Institute Professor of Ophthalmology, Dept of Ophthalmology, National University of Singapore President, Asia Cornea Society President-Elect, The Cornea Society Financial Disclosures: B&L, Carl Zeiss Meditec, Santen, AcuFocus, Network Medical Products, Pfizer Japan SNEC first started refractive surgery in over, procedures to date We have gone through excimer lasers, microkeratomes and femtosecond lasers Our current equipment: (% femtolasik) Excimer Lasers:. Technolas z (B&L). Wavelight Allegretto (Alcon) Microkeratomes:. XP Microkeratome (B&L). Moria CB Microkeratome Femtolasers:. Intralase. VisuMax (Carl Zeiss Meditec) Refractive Lenticule Extraction Current ReLEx Investigators A new refractive approach using the VisuMax Laser from Carl Zeiss Meditec an alternative to conventional lasik Uses only the femtosecond laser to perform refractive lamellar surgery, i.e, no need for an excimer laser EUROPE Germany: Turkey: Russia: Italy: ASIA Walter Sekundo, Klinik für Augenheilkunde, Marburg Marcus Blum, Helios Klinik, Erfurt Osama Ibrahim, Alex Cornea Center Igor Solomatin, The Eye Rehabilitation Center Mario Nubile, University of Chieti and Pescara Incising an intrastromal refractive lenticule with the femtosecond laser Tissue photodisruption instead of tissue ablation Treatment currently limited to D of myopia (SE) and D of astigmatism Two clinical procedures:. : Femtosecond Lenticule Extraction LASIK type flap. SMILE: Small Incision Lenticule Extraction - pocket incision (no flap) India: Rupal Shah, New Vision Laser Centers Korea: Eui-Sang Chung, Samsung Medical Centre Shanghai: Zhou Xing Tou, Shanghai Eye & ENT Hospital, Fudan University Thailand: Ekkat Chansue Singapore: Donald Tan, SNEC, SERI Over procedures performed to date Results very similar to LASIK, with no nomogram adjustment

2 // Femtosecond Lenticule Extraction Our first case in Singapore Preop: -. / -. x = / Day : / - UA Week: / UA Month: / UA, +. DS = / Months: / - UA, +. DS = / months: / - UA SMall Incision Lenticule Extraction (SMILE) Pseudo-SMILE Procedure Pocket incision procedure (no flap) Side-cut made in only one quadrant (superior) Lenticule extracted through the pocket incision Significant advantages: - tectonically stronger wound - less discomfort (small wound) -? less dry eye (neurotrophic keratitis) One potential disadvantage: how would one approach enhancement? (current alternatives: microkeratome LASIK, surface ablation) Alternative procedure: PSEUDO-SMILE Standard -type flap incision (full flap) Full flap not lifted only small pocket incision opened Main advantage: full flap has already been cut, hence enhancement by lifting a full flap and performing excimer ablation is possible

3 // Tan FemtoLamellar Dissector (ASICO) : Slit-lamp appearance (I have no financial interest!) Tan Femtolamellar Dissector for closed flap dissection, and very useful for sticky OBL! Pseudo-SMILE Outcomes first eyes Singapore ReLEx Study: Our Early Clinical Results Preop SE Preop Sph Preop Cyl UCVA mos SE mos Sph mos Cyl mos UCVA mos BCVA / / / /... / / /.. -. /. / /.. -. / / /... / / /... / /. started ReLEx in March single surgeon (DT) cases cases of, cases of No algorithm adjustment with months follow-up with months follow-up My first cases: Day Month Refraction/BCVA. R: -./-. x / - / plano: / Day postop L: -./-. x / - / plano: /. R: -./-. x / / plano / -. x : / L: -./-. x / / plano: /

4 // One Complication Encountered One complication (surgeon and Zeiss advisor error) yr old female: -./-.x Early suction loss during first lenticular cut procedure immediately repeated - double cut noted during lenticule removal (procedure should have been abandoned, and LASIK performed mins later) st POD: / ua week: -./-.x: / months: plano/-.x: /p Enhancement (flap lift) performed: st POD: /.p month post-enhancement: / ua, +./-.x: / (clinical data from this patient omitted from overall analysis) All Chinese patients: females, males Mean age: yrs (range - yrs) Wide array of myopia low to moderate myopes Pre-Op Refraction (n=) -.D (-. to -.D) -.D (-. to -.D) -.D ( to -.D) (n=) -.D (-. to -.D) -.D (-. to -.D) -.D ( to -.D) (n=) -.D (-. to -.D) -.D (-. to -.D) -.D ( to -.D) Week Results (n=) Month Results (n=) Post-Op Refraction (n=) (n=) (n=) Post-Op Refraction (n=) (n=) (n=).d (. to -.D).D (. to -.D).D (. to -.D).D (. to -.D).D (. to -.D).D (. to -.D).D (. to -.D).D (. to -.D).D (. to -.D).D (. to -.D).D (. to -.D).D (. to -.D) -.D ( to.d) -.D ( to.d) -.D ( to -.D) -.D ( to.d) -.D ( to.d) -.D ( to -.D)

5 // Month Results (n=) Month Results (n=) Post-Op Refraction (n=) (n=) (n=) Post-Op Refraction (n=) (n=) (n=).d (. to -.D).D (. to -.D).D (. to -.D).D (. to -.D).D (. to -.D).D (. to -.D).D (. to -.D).D (. to -.D).D (. to -.D).D (. to -.D) -.D ( to.d) -.D ( to.d) -.D ( to -.D) -.D ( to.d) -.D ( to.d) Singapore ReLEx Study: Efficacy Refractive Outcome (MR SEQ % within attempted) -. D to -. D % % -. D to -. D % () Pseudo-SMILE () -. D to -. D - Week -. D to -. D % % % +/-. D +.D to +.D - Month % % % % +. D to +. D +/-. D +.D to +.D % % +. D to +. D -. D to -. D - Month -. D to -. D () Pseudo-SMILE () % % % % % % % +/-. D +.D to +.D - Month: +. D to +. D : % ±. % +.D : % ±. D % ±. D Singapore ReLEx Study: Stability pre op w m m m -. pre op w m m Time Time () Pseudo-SMILE ()

6 // Predictability: Predictability: months week month months High predictability without any nomogram adjustment, unlike excimer laser nomograms week month months % % % % % % % % % % % % % % % Singapore ReLEx Study: Safety Change in - Week % % % % unchanged lost> lost gained lost lost unchanged gained gained lost> lost gained % % % % % % % % - Month % % % % % % % % Singapore ReLEx Study: Efficacy: (UAVA ) - Week % % % % % % % / / / / / - Month % % % % % % % % / / / / / () Pseudo-SMILE () () Pseudo-SMILE () () Pseudo-SMILE () () Pseudo-SMILE - Month % % % % % % % % % % % % % % % % lost> lost lost unchanged gained gained () Pseudo-SMILE () Change in - Month: : % unchanged/gained Pseudo-SMILE: % unchanged/gained - Month % % % % % % % / / / / / () Pseudo-SMILE () - Month: : % / % / Pseudo-SMILE: % / % /

7 // The Future of Refractive Lenticule Extraction Lenticule Storage in Tissue Culture Media Two major advantages over LASIK: Quantum Leaps? The future of this technology lies in SMILE: no flap: perhaps less dry eye or neurotrophic keratitis a major advance over LASIK Efficacy and Safety indices are OK, but it would be nice to have faster visual recovery matching LASIK Potential reversibility of ReLEx: new concept of long-term lenticule storage for patients lenticules may be re-implanted back at a later stage, in the event of keratectasia, refractive shift, or even to restore myopia for presbyopic correction* Lenticules may be donated for other patients (allograft ALK tissue) * SERI research program : Storage of lenticules following femtosecond refractive lenticule procedures from cornea for subsequent reimplantation: Tan, Mehta (patent filed: #/,) Lenticule Re-Implantation days after days after lenticule re-implantation month post- Flap re-lift Frozen lenticule stored on RGP lens performed, lenticule placed on RGP CL and stored at - C Flap relifted at mth, lenticule replaced in correct anatomical orientation Flap replaced Flap repositioning Replacement of lenticule Mehta, Riau et al.... Before days after days after re-implantation of lenticule days after re-implantation of lenticule

8 // AS-OCT Imaging Non-human Primate Model Before procedure days after procedure Primate model essential for wound healing and true refractive model, closest to human eye ReLEx studies in primate eyes initiated at SERI Final proof of concept of ReLEx reversibility days after re-implantation of lenticule days after re-implantation of lenticule Before days after days after Summary Acknowledgements ReLEx appears to be a promising new modality which may well challenge the superiority of LASIK further clinical studies continue, including a direct comparison with our best LASIK results Early clinical results of both and, with no nomogram adjustment appear to confirm good refractive efficacy predictability, stability and safety Flap-less is also highly promising, with major advantages of better tectonic strength, and possibly less dry eye and ocular surface disturbance Potential reversibility of ReLEx procedures may be a reality The SingLasik Research Group SNEC Cornea and Refractive Services Assoc Prof Jod Mehta Dr Mohamad Rosman Dr Cordelia Chan Dr Chan Tat Keong Dr Chua Wei Han Dr Lim Li Dr Raymond Loh Dr Ti Seng Ei Dr Peter Tseng Dr Natasha Lim Dr Arundhati Anshu Dr Daphne Han Dr Allan Fong Dr Federico Luengo Dr Leonard Yuen Jane Koh SERI Corneal Research Scientists Prof Roger Beuerman Dr Shyam Chauarsia Dr Romesh Dr Win Sum Lee Andri Riau Singapore Eye Bank A/Prof Heng Wee Jin Carisa Mariella Paraz Dr Lim Li Zhang Jia Qin Dr Howard Cajucom-Uy Jenny Zheng Djoni Agahari Yik Pei Lin Selvam Sethuraman Yong Jin Hua Grant Support: National Research Foundation NMRC Carl Zeiss Meditech Translational Clinical Research (TCR) Flagship Grant: TRIOS