Financial Disclosures

LaserACE® & the VisioLite® System: A Disruptive Technology in VisioDynamic Functionality

Hipsley, AM. VisioDynamics® Theory: A Biomechanical Application for the Aging Eye . Step by Step Innovations in Presbyopia management. Jaypee Medical Publishers. 2003.

The Natural Restorative Solution

•  Unique 2.94 µm wavelength (better water absorption)

•  First bladeless microsurgery device for eye tissue

•  Vaporizes: no cutting or burning (less collateral tissue damage)

•  Patented fiberoptic tips

•  Novel synthetic collagen BioMatrix for anti-scarring

LaserACE® Instruments

•  Erbium Yag laser to create regions of increased plasticity on the sclera

•  NO alteration of the shape of the sclera, cornea or crystalline lens

•  Increased plasticity is presumed to increase the mechanical advantage of the ciliary muscle = facilitating accommodation

LaserACE® Procedure

VisioLite® Ophthalmic Er:Yag laser with fiber optic probe

Mathematical Diamond Matrix Pattern

Unique Deformational Behavior

LaserACE® Surgical Technique

LaserACE® Surgery Matrix Marker

Video Courtesy Dr. David HK Ma

LaserACE® Surgery Ablation Takes 3-7 seconds

Video Courtesy Dr. David HK Ma

BEFORE COLLAGEN AFTER COLLAGEN

•  NOT performed on the Visiual Axis of the eye •  Can still perform future corneal or cataract surgery •  May have an additive effect to improve results

–  Monovision with LaserACE may be more effective than monovision alone

–  Presbyopia-correcting CL, accommodating IOLs, prior monofocal pseudophakic emmetropes

•  May provide better distance vision for post-LASIK patients with slight hyperopia postop when a second excimer laser treatment on the cornea cant be done

LaserACE® Procedure Advantages

•  134 eyes of 67 patients, all performed bilaterally •  Several iterations of the ablation technique/patterns •  Up to 18 months follow-up for a high percentage •  Techniques for measuring accommodation were

objective (iTrace aberrometer, COAS-HD with Dynamic Stimulation Aberrometry)

•  Clinically and statistically significant change in objectively measured amplitude of accommodation in all patients (1.25-1.50 D average)

Longitudinal data for 37 patients, objectively measured with the iTrace system

Statistically Significant Increase in Objective Accommodation

1.00

– 1

.75

Objective •  Prospective IRB-monitored evaluation of Near and

Intermediate Vision (primary endpoints) and Binocular Defocus Curves (secondary endpoint) before and after LaserACE® procedure

•  Tracey Study performed on subgroup of patients •  Catquest ‒ 9SF QOL patient questionnaire

Sample size •  45  subjects  with  planned  bilateral  LaserACE®  treatment    

Duration / Follow-up  •  Baseline,  POD  1/3,  1  WK,  1  M,  3M,  6M,  12M,18  M,  24M  

LaserACE® Taiwan Clinical Trial

•  ≥40 years of age with a demonstrated loss of accommodative function

•  Good uncorrected distance vision with less than 1.0D of refractive astigmatism and otherwise healthy eyes

•  Prior laser refractive surgery allowed

•  Summary Data of the first 15 patients with minimum 3 M post op shared

Inclusion Criteria

Uncorrected Distance Vision 100% stable or improved at 3M

Uncorrected Intermediate Vision 89% 20/30 or better at 3M

Uncorrected Near Vision 89% 20/30 or better at 3M

Comparison Table of Jaeger values, equivalent Snellen distance acuities and point sizes for Times New Roman font is shown above. Newsprint is typically between 10- and 14-point or between J7 and J10

Jaeger   Snellen   Point   Actual  

J1+   20/20   3   3  

J1   20/25   4   4  

J2   20/30   5   5  

J3   20/40   6   6  

J5   20/50   8   8  

J7   20/70   10   10  

J10   20/100   14   14  

Near Vision 89% J2 or Better After LaserACE®

Jaeger/Snellen/Times Roman Visual Acuity Measures

Range Restored

Binocular Defocus Curve Example of ideal 25 year old accommodation

Binocular Defocus Curve LaserACE® Evidence of Restored Accommodation

LaserACE® Does NOT Affect Stereoacuity

LaserACE® Potential Restorative Ocular Health Effect IOP Reduction

Patient Pre-­‐Op  LaserACE % Post-­‐Op  LaserACE®   %

1 Somewhat Difficult 100 No  Difficulty 100

2 Very Difficult 40 No  Difficulty 70

3 Somewhat Difficult 60 No  Difficulty 90

4 Great Difficult 60 No  Difficulty 30

6 Great Difficult 90 No  Difficulty 50

LaserACE® Improves Quality of Life

Catquest – 9SF

Lundström M, Pesudovs K. Catquest-9SF patient outcomes questionnaire: nine-item short-form Rasch-scaled revision of the Catquest questionnaire. J Cataract Refract Surg. 2009 Mar;35(3):504-13

•  Patients between 1-5 mos post op (min 3M) •  Patients achieved improvement of both Near & Intermediate Vision •  2 to 4 lines of improved reading vision seen

•  No loss of Distance Vision •  High patient satisfaction postoperatively •  Accommodative amplitude continued improvement from 1-3 months

•  Lens hardening/older patients may be exclusionary based on one low responder

Conclusions LaserACE® Early Clinical Taiwan Trial

•  Early data from Pilot Studies & Taiwan Clinical Trial indicate “YES”

•  A Potential Positive Effect on Accommodation with NO CHANGE in Refractive Status is possible with LaserACE® procedure.

Does LaserACE® Work?

UNIQUE BENEFITS All Presbyopes Eligible except eliminated by Exam (cataract) Untouched Lens Ciliary Muscle Mobility No Device Inserted Accommodative System Improvement Delay Disease Progression (IOP control)

LaserACE® Natural Solution Benefits

Unlike any other procedure, LaserACE ®: •  Less invasive in comparison to all other procedures

•  Can be a companion with other refractive surgeries without refractive compromise for life course vision

•  Foreseeable other potential health benefits for restoring accommodative muscular function

LaserACE® Procedure Summary

Taiwan 101 Milan Duomo