Transparency of Transition Transparency of Transition from 2.75 mm to 1.8 mm from 2.75 mm to 1.8 mm

Microincision SurgeryMicroincision Surgery

Jay McDonald II, MDJay McDonald II, MDAdjunct Clinical Professor Adjunct Clinical Professor

University of Arkansas School of MedicineUniversity of Arkansas School of Medicine

Financial Interest: AcuFocus, Addition Technology, Advanced Vision Science, Alcon Laboratories, Bausch & Lomb, Ophthalmic Innovations Intl.

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PurposePurpose

To evaluate the To evaluate the StellarisStellaris Vision Vision Enhancement System for transition from Enhancement System for transition from 2.75 mm to 1.8 mm microincision 2.75 mm to 1.8 mm microincision phacoemulsification surgeryphacoemulsification surgery

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Field Observation Study (FOS)Field Observation Study (FOS)

The The StellarisStellaris Vision Enhancement System Vision Enhancement System to perform phacoemulsification cataract to perform phacoemulsification cataract extractionextraction

50 sites (2,000 cases) USA, Europe, 50 sites (2,000 cases) USA, Europe, and Asia and Asia 20 cataract procedures per group20 cataract procedures per group

Surgeon experience questionnaire Surgeon experience questionnaire 11 procedures (small and microincision) 11 procedures (small and microincision)

data presented heredata presented here

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FOS-MethodFOS-Method Surgery techniquesSurgery techniques

Standard coaxialStandard coaxial Coaxial micro-incision cataract surgery (C-MICS)Coaxial micro-incision cataract surgery (C-MICS) Biaxial (bimanual) micro-incision cataract surgery (B-MICSBiaxial (bimanual) micro-incision cataract surgery (B-MICS

Consistency: all eyes implanted with the SofPort Advanced Optics IOL Consistency: all eyes implanted with the SofPort Advanced Optics IOL (LI61AO)(LI61AO)

Operative assessments: fragmentation, followability and holdability of Operative assessments: fragmentation, followability and holdability of nuclear fragments, chamber stability and instances of surge, as well as nuclear fragments, chamber stability and instances of surge, as well as changes to technique necessitated by the change from a 2.75 mm to 1.8 changes to technique necessitated by the change from a 2.75 mm to 1.8 mm incisionmm incision

MeasuresMeasures Average phaco power (APP)Average phaco power (APP) Average phaco time (APT)Average phaco time (APT) Equivalent phaco time (EPT)Equivalent phaco time (EPT) Case timeCase time BBS used during caseBBS used during case Corneal clarity on the first postoperative dayCorneal clarity on the first postoperative day

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StellarisStellaris versus versus MillenniumMillennium™™  Phaco EPT APT Phaco

Vacuum mm Hg

I&A Vacuum mm Hg

Bottle Height BBS Total Phaco/I&A Time

Stellaris (1) 20% 0:05.24 0:25.98 75 (max 200) 50 (max 600) 140 cm 68 cc 6 min.

(2) 22% 0:03.93 0:03.93 130 (max 200) 375 (max 600) 140 cm 76 cc 4 min.

(3) 17% 0:01.58 0:09.26 75 (max 200) 250 (max 600) 140 cm 81 cc 6 min.

(4) 36% 0:18.41 0:50.58 75 (max 200) 140 (max 600) 140 cm 143 cc 7 min.

(5) 19% 0:04.64 0:23.71 80 (max 200) 130 (max 600) 140 cm 92 cc 6 min.

Mature Cut (6) 32% 0:24.55 1:16.74 60 (max 200) 120 (max 600) 140 cm 178 cc 13 min.

Millennium (1) 11% 00:51 00:05 78 (max 170) 270 (max 550) 120 cm/110 cm 200 cc 4 min.

(2) 12% 00:27 00:03 116 (max 170) 215 (max 550) 120 cm/110 cm 180 cc 4 min.

(3) 5% 00:20 00:01 110 (max 170) 220 (max 550) 120 cm/110 cm 180 cc 4 min.

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Postoperative ResultsPostoperative Results

Physician efficiency: faster real time surgery with Physician efficiency: faster real time surgery with StellarisStellaris vs. Millennium™ (0:9.80 vs. 0:32.70) vs. Millennium™ (0:9.80 vs. 0:32.70)

StellarisStellaris uses 41% less BBS during the uses 41% less BBS during the procedure (Mean=106.4cc vs. 186.7cc)procedure (Mean=106.4cc vs. 186.7cc) Less fluid irrigated through the patient's anterior Less fluid irrigated through the patient's anterior

chamber reduces the endothelial cell exposure to the chamber reduces the endothelial cell exposure to the irrigation turbulenceirrigation turbulence

Less endothelial cell damage reduces corneal stromal Less endothelial cell damage reduces corneal stromal edema during the immediate (POD #1), and mid-edema during the immediate (POD #1), and mid-range (POW#1) post-operative periodrange (POW#1) post-operative period

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Surgical EfficiencySurgical Efficiency StellarisStellaris uses 31% less phaco vacuum than Millennium™ uses 31% less phaco vacuum than Millennium™

Increased "purchase" efficiency during the emulsification of the Increased "purchase" efficiency during the emulsification of the nuclear segmentnuclear segment

Greater "cutting efficiency" during the procedureGreater "cutting efficiency" during the procedure More efficient vacuum fluidics increases chamber stabilityMore efficient vacuum fluidics increases chamber stability Reduces fluid turbulence which may cause corneal endothelial cell Reduces fluid turbulence which may cause corneal endothelial cell

traumatrauma• StellarisStellaris Z average=41.36 mm Hg max of 200 mm Hg Z average=41.36 mm Hg max of 200 mm Hg• Millennium™ Z average =59.7 mm Hg max of 170 mm HgMillennium™ Z average =59.7 mm Hg max of 170 mm Hg

StellarisStellaris uses 25% less I/A vacuum than Millennium™, during uses 25% less I/A vacuum than Millennium™, during aspiration of the lens cortical remnants and viscoelasticaspiration of the lens cortical remnants and viscoelastic

Increased fluidics efficiencyIncreased fluidics efficiency Less turbulenceLess turbulence Less potential endothelial cell damageLess potential endothelial cell damage

• StellarisStellaris Z average=177.5 mm Hg max of 600 mm Hg Z average=177.5 mm Hg max of 600 mm Hg• Millennium™ Z average =235 mm Hg max of 550 mm HgMillennium™ Z average =235 mm Hg max of 550 mm Hg

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Personal ExperiencePersonal Experience

Seamless transition from 2.8 mm to Seamless transition from 2.8 mm to 1.8 mm phaco1.8 mm phaco

The smaller hand piece improves my The smaller hand piece improves my maneuverability within the eye with no loss maneuverability within the eye with no loss of cutting efficiencyof cutting efficiency

My phaco times have decreased 10 My phaco times have decreased 10 percent and fluid as well as power in the percent and fluid as well as power in the eye has continued to decrease with timeeye has continued to decrease with time

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Post Op OutcomesPost Op Outcomes

Nuclear fragmentation, followability, and Nuclear fragmentation, followability, and holdability were judged excellent holdability were judged excellent

No instances of surge were reported to No instances of surge were reported to date date

Phaco power and case time were low Phaco power and case time were low Corneal clarity at Day 1 postoperative Corneal clarity at Day 1 postoperative

exam was judged excellentexam was judged excellent

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ConclusionConclusion

The The StellarisStellaris Vision Enhancement System Vision Enhancement System supports a wide range of phaco supports a wide range of phaco procedures, and has incorporated fluidics procedures, and has incorporated fluidics and power innovations that allow surgeons and power innovations that allow surgeons to segue smoothly to microincision phacoto segue smoothly to microincision phaco

To date, the move to microincision phaco To date, the move to microincision phaco appears to be very straightforward, and appears to be very straightforward, and patient outcomes have been uniformly patient outcomes have been uniformly excellentexcellent