Evaluation of Safety and Effectiveness of Multizone Laser Vision Correction in Presbyopic Patients ASCRS 2010 Paul Van Saarloos PhD – CustomVis, employee.

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Evaluation of Safety and Effectiveness of Multizone Laser Vision Correction in Presbyopic Patients ASCRS 2010 Paul Van Saarloos PhD – CustomVis, employee Tarak Pujara MS – CustomVis, employee Tarak Pujara MS – CustomVis, employee Gabriel Marín MD - Clínica Medellín, no financial interest

Patients and Methods Lasik Multi-zone (version 2.1.1) Presbyopia Surgery was performed in the Non-dominant Eye of 41 patients. Lasik Multi-zone (version 2.1.1) Presbyopia Surgery was performed in the Non-dominant Eye of 41 patients. 213 nm. Wave length Pulzar Z1 Solid State Refractive Laser, 0.6mm spot. 213 nm. Wave length Pulzar Z1 Solid State Refractive Laser, 0.6mm spot. Laser Presbyopia Software developed by Paul van Saarloos PhD. was used. Laser Presbyopia Software developed by Paul van Saarloos PhD. was used. Moria CB and Hansatome Microkeratomes Moria CB and Hansatome Microkeratomes Near and Far UCVA preop. and postop. were compared as well as Patient Satisfaction and Wavefront results. Near and Far UCVA preop. and postop. were compared as well as Patient Satisfaction and Wavefront results.

41 Patients 31 females 31 females 10 males 10 males Age range: 43 – 67 years old Age range: 43 – 67 years old Avg: yrs. Avg: yrs. Follow-up: 6 months Follow-up: 6 months Preoperative Refraction Preoperative Refraction Plano : 6 patients Plano : 6 patients +0.50D and SE : 11 patients +0.50D and SE : 11 patients +1.25D and SE : 24 patients +1.25D and SE : 24 patients

Pulzar Z1 Solid State Refractive Laser 213 nm wave length generated from 1064nm Nd:YAG source 213 nm wave length generated from 1064nm Nd:YAG source Less heat induced to the cornea than Argon–Fluoride Excimer lasers Less heat induced to the cornea than Argon–Fluoride Excimer lasers Low interference of laser energy by humidity compared to ArF Excimers Low interference of laser energy by humidity compared to ArF Excimers 0.6mm flying spot 0.6mm flying spot Silent laser Silent laser No gases required No gases required

Laser Presbyopia Software In Development by Paul Van Sarloos PhD In Development by Paul Van Sarloos PhD Central Far Vision Zone Central Far Vision Zone Mid-zone Near Vision Mid-zone Near Vision Peripheral Far vision Zone Peripheral Far vision Zone Smooth Transition between Zones Smooth Transition between Zones Minimal Tissue remov al Minimal Tissue remov al

Lasik Cuts Performed by Moria CB and Hansatome microkeratomes Performed by Moria CB and Hansatome microkeratomes Flap Thickness Range : microns Flap Thickness Range : microns Average of Flap Thickness : 113 Average of Flap Thickness : 113 microns microns No flap complications No flap complications

RESULTS : Preoperative UCVA NEAR UCVA FAR UCVA NEAR UCVA FAR UCVA PREOP. NEAR UCVA VAPATIENTS% 20/2512.4% 20/ % 20/ % 20/ % 20/ % 20/8049.8% 20/ % 20/ % 20/ % TOTAL % PREOP. FAR UCVA VAPATIENTS% 20/ % 20/2549.8% 20/ % 20/ % 20/5012.4% 20/6012.4% 20/7024.9% 20/8012.4% 20/ % 20/ % TOTAL % 97.6% had 20/40 or less47.2% had 20/40 or less

RESULTS: Postoperative UCVA NEAR UCVA FAR UCVA NEAR UCVA FAR UCVA 100% 20/40 OR BETTER 97.5% 20/30 OR BETTER 80.5% 20/40 OR BETTER VAPATIENTS% 20/ % 20/ % 20/3037.3% 20/4012.4% TOTAL % VAPATIENTS% 20/ % 20/ % 20/ % 20/ % 20/5049.8% 20/6037.3% 20/7012.4% TOTAL %

PATIENT SATISFACTION NEAR UCVA NON DOMINANT EYE Very HappySatisfiedUnsatisfiedVery Unhappy PREOP2.4 %24.4 %73.2 % POSTOP90.2 %7.3 %2.5 %0

PATIENT SATISFACTION NEAR

VISUAL ACUITY 20/15 20/30 20/25 20/20 20/30 20/40 20/50 Improving Vision

ENHANCEMENTS Undercorrections: 5 Patients. Undercorrections: 5 Patients. Overcorrections: 1 Patient. Overcorrections: 1 Patient.POSTENHANCEMENTS NEAR VISION PREOP.POST. 20/2520/20 20/2520/20 20/3020/20 20/3020/20 20/3020/20 20/2520/20 FAR VISION PREOP.POST. 20/4020/20 20/7020/25 20/4020/50 20/3020/20 20/2520/20

ABERRATIONS LO TOTALHO TOTALCOMATREFOIL PREPOSTDIFPREPOSTDIFPREPOSTDIFPREPOSTDIF AVG RANG

CONCLUSIONS Near vision results and patient satisfaction in the non-dominant eye Presbyopia treatments were very good, (97.5%) 20/30 or better. Near vision results and patient satisfaction in the non-dominant eye Presbyopia treatments were very good, (97.5%) 20/30 or better. 95.5% of the patients had also good bilateral far vision and were satisfied and happy. 95.5% of the patients had also good bilateral far vision and were satisfied and happy. 65.9% had good UCVA far vision in the non- dominant eye.(20/30 or better). Far vision is much better than in mono-vision patients. 65.9% had good UCVA far vision in the non- dominant eye.(20/30 or better). Far vision is much better than in mono-vision patients. 5 patients were unsatisfied with the non- dominant eye for near vision. (Required enhancement) 5 patients were unsatisfied with the non- dominant eye for near vision. (Required enhancement) Far vision results have a tendency to improve with time. Far vision results have a tendency to improve with time. A slight increase in High Order Aberrations as well as Trefoil and Coma were observed, but similar to standard LASIK. A slight increase in High Order Aberrations as well as Trefoil and Coma were observed, but similar to standard LASIK.

Conclusion Presbyopic Multizone Lasik surgery is a safe procedure and gives better results and patient satisfaction than mono-vision. Presbyopic Multizone Lasik surgery is a safe procedure and gives better results and patient satisfaction than mono-vision. Paul van Saarloos has a financial interest in the CustomVis Pulzar Z1 Solid State Laser.