Transparency of Transition from 2.75 mm to 1.8 mm Microincision Surgery Jay McDonald II, MD Adjunct Clinical Professor University of Arkansas School of Medicine Financial Interest: AcuFocus, Addition Technology, Advanced Vision Science, Alcon Laboratories, Bausch & Lomb, Ophthalmic Innovations Intl.

2 Purpose  To evaluate the Stellaris Vision Enhancement System for transition from 2.75 mm to 1.8 mm microincision phacoemulsification surgery

3 Field Observation Study (FOS)  The Stellaris Vision Enhancement System to perform phacoemulsification cataract extraction  50 sites (2,000 cases) USA, Europe, and Asia 20 cataract procedures per group 20 cataract procedures per group  Surgeon experience questionnaire  11 procedures (small and microincision) data presented here

4 FOS-Method  Surgery techniques Standard coaxial Standard coaxial Coaxial micro-incision cataract surgery (C-MICS) Coaxial micro-incision cataract surgery (C-MICS) Biaxial (bimanual) micro-incision cataract surgery (B-MICS Biaxial (bimanual) micro-incision cataract surgery (B-MICS  Consistency: all eyes implanted with the SofPort Advanced Optics IOL (LI61AO)  Operative assessments: fragmentation, followability and holdability of 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 mm incision  Measures 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 time Case time BBS used during case BBS used during case Corneal clarity on the first postoperative day Corneal clarity on the first postoperative day

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7 Stellaris versus Millennium™ PhacoEPTAPTPhaco Vacuum mm Hg I&A Vacuum mm Hg Bottle HeightBBSTotal Phaco/ I&A Time Stellaris (1)20%0:05.240: (max 200)50 (max 600)140 cm68 cc6 min. (2)22%0: (max 200)375 (max 600)140 cm76 cc4 min. (3)17%0:01.580: (max 200)250 (max 600)140 cm81 cc6 min. (4)36%0:18.410: (max 200)140 (max 600)140 cm143 cc7 min. (5)19%0:04.640: (max 200)130 (max 600)140 cm92 cc6 min. Mature Cut (6)32%0:24.551: (max 200)120 (max 600)140 cm178 cc13 min. Millennium (1)11%00:5100:0578 (max 170)270 (max 550)120 cm/110 cm200 cc4 min. (2)12%00:2700:03116 (max 170)215 (max 550)120 cm/110 cm180 cc4 min. (3)5%00:2000:01110 (max 170)220 (max 550)120 cm/110 cm180 cc4 min.

8 Postoperative Results  Physician efficiency: faster real time surgery with Stellaris vs. Millennium™ (0:9.80 vs. 0:32.70)  Stellaris uses 41% less BBS during the procedure (Mean=106.4cc vs cc) Less fluid irrigated through the patient's anterior chamber reduces the endothelial cell exposure to the irrigation turbulence Less fluid irrigated through the patient's anterior chamber reduces the endothelial cell exposure to the irrigation turbulence Less endothelial cell damage reduces corneal stromal edema during the immediate (POD #1), and mid- range (POW#1) post-operative period Less endothelial cell damage reduces corneal stromal edema during the immediate (POD #1), and mid- range (POW#1) post-operative period

9 Surgical Efficiency  Stellaris uses 31% less phaco vacuum than Millennium™ Increased "purchase" efficiency during the emulsification of the nuclear segment Increased "purchase" efficiency during the emulsification of the nuclear segment Greater "cutting efficiency" during the procedure Greater "cutting efficiency" during the procedure More efficient vacuum fluidics increases chamber stability More efficient vacuum fluidics increases chamber stability Reduces fluid turbulence which may cause corneal endothelial cell trauma Reduces fluid turbulence which may cause corneal endothelial cell trauma Stellaris Z average=41.36 mm Hg max of 200 mm HgStellaris 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  Stellaris uses 25% less I/A vacuum than Millennium™, during aspiration of the lens cortical remnants and viscoelastic Increased fluidics efficiency Increased fluidics efficiency Less turbulence Less turbulence Less potential endothelial cell damage Less potential endothelial cell damage Stellaris Z average=177.5 mm Hg max of 600 mm HgStellaris 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

10 Personal Experience  Seamless transition from 2.8 mm to 1.8 mm phaco  The smaller hand piece improves my maneuverability within the eye with no loss of cutting efficiency  My phaco times have decreased 10 percent and fluid as well as power in the eye has continued to decrease with time

11 Post Op Outcomes  Nuclear fragmentation, followability, and holdability were judged excellent  No instances of surge were reported to date  Phaco power and case time were low  Corneal clarity at Day 1 postoperative exam was judged excellent

12 Conclusion  The Stellaris Vision Enhancement System supports a wide range of phaco procedures, and has incorporated fluidics and power innovations that allow surgeons to segue smoothly to microincision phaco  To date, the move to microincision phaco appears to be very straightforward, and patient outcomes have been uniformly excellent