Evaluation of Safety and Evaluation of Safety and Effectiveness of Multizone Effectiveness of Multizone Laser Vision Correction in Laser Vision Correction in

Presbyopic PatientsPresbyopic Patients

ASCRS 2010ASCRS 2010

Paul Van Saarloos PhD – CustomVis, employeePaul Van Saarloos PhD – CustomVis, employee

Tarak Pujara MS – CustomVis, employeeTarak Pujara MS – CustomVis, employee

Gabriel Marín MD - Clínica Medellín, no financial interestGabriel Marín MD - Clínica Medellín, no financial interest

Patients and MethodsPatients and Methods Lasik Multi-zone (version 2.1.1) Presbyopia Lasik Multi-zone (version 2.1.1) Presbyopia

Surgery was performed in the Non-dominant Surgery was performed in the Non-dominant Eye of 41 patients.Eye of 41 patients.

213 nm. Wave length Pulzar Z1 Solid State 213 nm. Wave length Pulzar Z1 Solid State Refractive Laser, 0.6mm spot.Refractive Laser, 0.6mm spot.

Laser Presbyopia Software developed by Paul Laser Presbyopia Software developed by Paul van Saarloos PhD. was used.van Saarloos PhD. was used.

MoriaMoria CB and Hansatome Microkeratomes CB and Hansatome Microkeratomes Near and Far UCVA preop. and postop. were Near and Far UCVA preop. and postop. were

compared as well as Patient Satisfaction and compared as well as Patient Satisfaction and Wavefront results.Wavefront results.

41 Patients41 Patients 31 females31 females 10 males 10 males Age range: 43 – 67 years old Age range: 43 – 67 years old

Avg: 53.61 yrs.Avg: 53.61 yrs. Follow-up: 6 monthsFollow-up: 6 months Preoperative RefractionPreoperative Refraction

Plano : 6 patientsPlano : 6 patients

+0.50D and +1.00 SE : 11 patients +0.50D and +1.00 SE : 11 patients

+1.25D and +2.25 SE : 24 patients+1.25D and +2.25 SE : 24 patients

Pulzar Z1 Solid State Refractive Pulzar Z1 Solid State Refractive LaserLaser

213 nm wave length generated from 213 nm wave length generated from 1064nm Nd:YAG source1064nm Nd:YAG source

Less heat induced to the cornea than Less heat induced to the cornea than Argon–Fluoride Excimer lasersArgon–Fluoride Excimer lasers

Low interference of laser energy by Low interference of laser energy by humidity compared to ArF Excimershumidity compared to ArF Excimers

0.6mm flying spot0.6mm flying spot Silent laserSilent laser No gases requiredNo gases required

Laser Presbyopia SoftwareLaser Presbyopia Software

In Development by Paul Van Sarloos PhDIn Development by Paul Van Sarloos PhD

Central Far Vision ZoneCentral Far Vision Zone

Mid-zone Near Vision Mid-zone Near Vision

Peripheral Far vision ZonePeripheral Far vision Zone

Smooth Transition between ZonesSmooth Transition between Zones

Minimal Tissue removMinimal Tissue removalal

Lasik CutsLasik Cuts

Performed by Moria CB and Performed by Moria CB and Hansatome microkeratomesHansatome microkeratomes

Flap Thickness Range : 84 - 172 Flap Thickness Range : 84 - 172 micronsmicrons

Average of Flap Thickness : 113 Average of Flap Thickness : 113

micronsmicrons No flap complicationsNo flap complications

RESULTS : Preoperative UCVARESULTS : Preoperative UCVA

NEAR UCVA FAR UCVANEAR UCVA FAR UCVAPREOP. NEAR UCVA

VA PATIENTS %

20/25 1 2.4%

20/40 5 12.2%

20/50 5 12.2%

20/60 6 14.6%

20/70 11 26.8%

20/80 4 9.8%

20/100 4 9.8%

20/200 3 7.3%

20/400 2 4.9%

TOTAL 41 100.0%

PREOP. FAR UCVA

VA PATIENTS %

20/20 9 22.0%

20/25 4 9.8%

20/30 9 22.0%

20/40 10 26.4%

20/50 1 2.4%

20/60 1 2.4%

20/70 2 4.9%

20/80 1 2.4%

20/100 3 7.3%

20/200 1 2.4%

TOTAL 41 100.0%

97.6% had 20/40 or less 47.2% had 20/40 or less

RESULTS: Postoperative UCVARESULTS: Postoperative UCVA

NEAR UCVA FAR UCVANEAR UCVA FAR UCVA

100% 20/40 OR BETTER97.5% 20/30 OR BETTER 80.5% 20/40 OR BETTER

VA PATIENTS %

20/20 31 75.6%

20/25 6 14.6%

20/30 3 7.3%

20/40 1 2.4%

TOTAL 41 100.0%

VA PATIENTS %

20/20 5 12.2%

20/25 10 24.4%

20/30 12 29.3%

20/40 6 14.6%

20/50 4 9.8%

20/60 3 7.3%

20/70 1 2.4%

TOTAL 41 100.0%

PATIENT SATISFACTIONPATIENT SATISFACTION

NEAR UCVA NON DOMINANT EYE

Very Happy Satisfied Unsatisfied Very Unhappy

PREOP 2.4 % 24.4 % 73.2 %

POSTOP 90.2 % 7.3 % 2.5 % 0 

PATIENT SATISFACTION NEARPATIENT SATISFACTION NEAR

PATIENTS SATISFACTION NEAR

73.2 %

0.0 %

24.4 %

2.4 %

2.4 %

7.3

0.0 %

90.2 %

0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95

POST

PRE

POST

PRE

POST

PRE

POST

PRE

Percentage

Very Unhappy

Unsatisfied

Satisfied

Very Happy

VISUAL ACUITYVISUAL ACUITY

FAR

1 WEEK 1 MONTH 3 MONTHS 6 MONHTS

FOLLOW UP

V.A.

NEAR

1 WEEK 1 MONTH 3 MONTHS 6 MONTHS

FOLLOW UP

V.A.

20/15

20/30

20/25

20/20

20/20

20/30

20/40

20/50Improving

Vision

ENHANCEMENTSENHANCEMENTS

Undercorrections: 5 Patients.Undercorrections: 5 Patients. Overcorrections: 1 Patient.Overcorrections: 1 Patient.

POSTENHANCEMENTSPOSTENHANCEMENTS

NEAR VISION

PREOP. POST.

20/25 20/20

20/25 20/20

20/30 20/20

20/30 20/20

20/30 20/20

20/25 20/20

FAR VISION

PREOP. POST.

20/40 20/20

20/70 20/25

20/40 20/50

20/30 20/20

20/25 20/20

 20/20 20/20

ABERRATIONSABERRATIONS

  LO TOTAL HO TOTAL COMA TREFOIL

  PRE POST DIF PRE POST DIF PRE POST DIF PRE POST DIF

AVG0.418 0.427 0.09 0.107 0.159 0.052 0.070 0.089 0.019 0.057 0.100 0.043

RANG.

0.10+0.75

0.04 +0.89

-0.96 +0.12

0.03+0.19

0.05+0.42

0.02 0.23

0.01+0.11

0.01+0.18

0 + 0.7

0.01

+0.16

0.09+0.21

0.8+0.5

WAVE FRONT ABERRATIONS

0,427

0.418

0,159

0.107

COMA, 0.089

0.071

TREFOIL 0.1

0,057

0 0.05 0.1 0.15 0.2 0.25 0.3 0.35 0.4 0.45

POST

PRE

POST

PRE

POST

PRE

POST

PRE

TOTAL HIGH ORDER

TOTAL LOW ORDER

CONCLUSIONSCONCLUSIONS Near vision results and patient satisfaction in the Near vision results and patient satisfaction in the

non-dominant eye Presbyopia treatments were very non-dominant eye Presbyopia treatments were very good, (97.5%) 20/30 or better.good, (97.5%) 20/30 or better.

95.5% of the patients had also good bilateral far 95.5% of the patients had also good bilateral far vision and were satisfied and happy. vision and were satisfied and happy.

65.9% had good UCVA far vision in the non-dominant 65.9% had good UCVA far vision in the non-dominant eye.(20/30 or better). Far vision is much better than eye.(20/30 or better). Far vision is much better than in mono-vision patients.in mono-vision patients.

5 patients were unsatisfied with the non-dominant 5 patients were unsatisfied with the non-dominant eye for near vision. (Required enhancement)eye for near vision. (Required enhancement)

Far vision results have a tendency to improve with Far vision results have a tendency to improve with time.time.

A slight increase in High Order Aberrations as well as A slight increase in High Order Aberrations as well as Trefoil and Coma were observed, but similar to Trefoil and Coma were observed, but similar to standard LASIK.standard LASIK.

ConclusionConclusion

Presbyopic Multizone Lasik surgery is a safe Presbyopic Multizone Lasik surgery is a safe procedure and gives better results and patient procedure and gives better results and patient satisfaction than mono-vision.satisfaction than mono-vision.

Paul van Saarloos hasa financial interest inthe CustomVis Pulzar Z1Solid State Laser.