J. Colin, MD

1
Visual and Safety Performance of the AcrySof
Phakic IOL in Global Clinical Trials

• Prof. Joseph Colin, MD
• Chef du Service d'Ophtalmologie - CHU Pellegrin
• Bordeaux, France
• (Financial Disclosure Consultant, Alcon)

• EU Phase 3 Clinical Investigators
• J. Alió, MD (Alicante, Spain)
• J.L. Arné, MD (Toulouse, France)
• R. Bellucci, MD (Verona, Italy)
• B. Cochener MD (Brest, France)
• J. Colin, MD (Bordeaux, France)
• R.H. Gerl, MD (Ahaus, Germany)
• M. Knorz, MD (Mannheim, Germany)
• T. Kohnen, MD (Frankfurt, Germany)
• A. Marinho, MD/F. Vaz, MD (Porto, Portugal)

• Canada Phase 3 Clinical Investigators
• T. Demong, MD (Calgary, Alberta)
• S. Holland, MD (Vancouver, British Columbia)
• M. Pop, MD (Montreal, Quebec)
• T. Rabinovitch, MD (Downsview, Ontario)
• F. Roy, MD (Trois-Rivieres, Quebec)

• US Phase 2 Clinical Investigators
• J. D. Horn, MD (Nashville, Tennessee )
• R. Krueger, MD (Cleveland, Ohio)
• S. S. Lane, MD (Stillwater, Minnesota)
• W. A. Maxwell, MD, PhD (Fresno, California)
• K. Solomon, MD (Charleston, South Carolina)

2
Clinical Study Design

• Clinical Objective Investigate safety
  effectiveness
• Study design Non-randomized, open label, single
  arm, multicenter clinical investigations
• Pooled analysis of global clinical studies
• 360 subjects included in total analysis
• European Phase 3 Clinical Study 190 subjects
• Canadian Phase 3 Clinical Study 120 subjects
• US Phase 2 Clinical Study 50 subjects
• 3 to 5 year follow-up duration
• Results reported for 2 year follow-up visit
  (n204)

L-Series AcrySof PIOL

• Anterior Chamber
• Angle-Supported
• Single-Piece IOL design
• Soft Acrylic (AcrySof IOL material)
• Monarch II IOL Delivery System
• Small incision size

Not approved for general use.
3
Study Criteria

• Main Inclusion Criteria
• Adults gt18 years of age, with cap of 49 years of
  age for US and Canadian study
• Stable, moderate to high myopia (refraction
  within 0.5 D at least 12 months prior to
  surgery)
• Able willing to sign informed consent
• Main Exclusion Criteria
• Previous ocular surgery
• Glaucoma or family history of glaucoma
• Mesopic pupil size gt7.0 mm
• Astigmatism gt2.0 D
• Anterior chamber depth lt3.2 mm
• Non-qualifying endothelial cell density per age
  criteria

4
Postoperative Evaluation

• Endothelial Cell Density (ECD) Morphology
• Adverse Events (AE)
• Maintenance of Best Spectacle-Corrected Visual
  Acuity (BSCVA)
• Uncorrected Distance Visual Acuity (UCVA)
• Best Spectacle-Corrected Distance Visual Acuity
  (BSCVA)
• Manifest Refraction Spherical Equivalent (MRSE)
• Predictability of Refraction

5
Endothelial Cell Density
Mean Acute Change in ECD (Actual) 6 months
postop (from preop)
Minimal effects on Acute Chronic ECD

• Mean Chronic Change in ECD (Annualized)
• 2 years postop (from 6 months postop)

6
Endothelial Cell Morphology
Endothelial Cell Percent Hexagonality Preop vs. 2
year visit
Stable Cell Morphology _at_ 2 year visit
Endothelial Cell Coefficient of Variation Preop
vs. 2 year visit
7
Adverse EventsCumulative through 2 years
postoperative
Out of 360 Subjects
AE Description
Rate
Incidence
8
Adverse Events, contd.
Out of 360 Subjects
AE Description
Rate
Incidence
9
Maintenance of BSCVA2 year visit
10
UCVA 2 year visit
BSCVA 2 year visit
11
Predictability of Refraction2 years postopn199
Mean Spherical Equivalent Preop to 2 year
12
Conclusions 2 year follow-up visit

• Safety Outcomes
• Minimal effects on ECD at 2 years postop
• BSCVA maintained
• No chronic inflammation or persistently raised
  IOP
• Low rate of adverse events observed
• Effectiveness Outcomes
• Excellent visual acuity
• High rate of predictability
• Refraction stable over time
• Clinical investigations ongoing