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
• 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
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
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