J. Colin, MDASCRS 2008
Visual and Safety Performance of the AcrySof® Phakic IOL in Global Clinical Trials
Prof. Joseph Colin, MDChef du Service d'Ophtalmologie - CHU PellegrinBordeaux, 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 InvestigatorsJ. 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)
J. Colin, MDASCRS 2008
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 (n=204)
Optic 6.0 mm
Overall length 12.5 mm
to 14.0 mm
Diopter Range -6.0 D to -16.5 D
L-Series AcrySof® PIOL
Not approved for general use.
Anterior Chamber Angle-Supported Single-Piece IOL design Soft Acrylic (AcrySof® IOL
material) Monarch® II IOL Delivery
System Small incision size
J. Colin, MDASCRS 2008
Study Criteria
Main Inclusion Criteria Adults >18 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 >7.0 mm Astigmatism >2.0 D Anterior chamber depth <3.2 mm Non-qualifying endothelial cell density per age criteria
J. Colin, MDASCRS 2008
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
Endothelial Cell Density
Mean Chronic % Change in ECD (Annualized)
2 years postop (from 6 months postop)
Mean Acute % Change in ECD(Actual)
6 months postop (from preop)
Minimal effects on Acute & Chronic ECD
-3.31 -2.98
-10-8-6-4-202468
10
Central, n=348 Peripheral, n=342
Me
an
EC
D %
Ch
an
ge
0.04
-0.31
-6
-4
-2
0
2
4
6
Central, n=197 Peripheral, n=191
Mea
n %
EC
D C
han
ge
Endothelial CellPercent Hexagonality
Preop vs. 2 year visit
Endothelial CellCoefficient of Variation
Preop vs. 2 year visit
Stable Cell Morphology@ 2 year visit
Endothelial Cell Morphology
57.70 57.8257.57
57.97
0
10
20
30
40
50
60
70
Central Peripheral
Mea
n %
Hex
ago
nal
ity
Preop 2 year
33.20 33.5332.26 32.03
0
10
20
30
40
Central Peripheral
Mea
n C
ell C
oeff
icie
nt o
f Var
iatio
nPreop 2 year
Cystoid Macular Edema 0 0%
Corneal Stromal Edema 0 0%
Corneal Haze 1 0.3%
Hyphema 0 0%
Hypopyon 0 0%
Intraocular Infection /Endophthalmitis 0 0%
Lens Dislocation 0 0%
Pupillary Block 0 0%
Retinal Detachment / Repair 0 0%
Raised IOP Requiring Treatment @ ≥1 month(Raised IOP Requiring Tx occurring @ ≥1 month due to:
Steroid Responders [8], Surgical Procedure [1], & Unknown Etiology [1].
One subject experienced 2 incidences.
No persistent or ongoing cases at 2 year vist.)
10 2.8%
Cataract Formation (Related to: Surgical procedure [3], & Concurrent ophthalmic disease [2])
5 1.4%
Adverse EventsCumulative through 2 years postoperative
Out of 360Subjects
AE Description RateIncidence
Synechia (Goniosynechia) 6 1.7%
Pupil Ovalization 0 0%
Hospitalization for Raised IOP (On Operative Day) 5 1.4%
Secondary Surgical Intervention (SSI)**One subject experienced 2 incidences
9 2.5%
IOL Replacement (Power exchange [2])
New Suturing (1)
Prophylactic Treatment by Argon Laser (1)
Preventive Iridotomy (1)
Laser coagulation of retinal hole (1)
IOL Removal (4)
(Upside down placement [1], Patient dissatisfaction [2], Glare with
7.0 mm mesopic pupil size [1])
Adverse Events, cont’d.AE Description RateIncidence
Out of 360Subjects
J. Colin, MDASCRS 2008
Maintenance of BSCVA2 year visit
0 0 0
42.6
35.6
4.5
17.3
0
10
20
30
40
50
60
>2 LineDecrease
2 LineDecrease
1 LineDecrease
NoChange
1 LineIncrease
2 LineIncrease
>2 LineIncrease
% o
f S
ub
ject
s
N=202
0 0 0
42.6
35.6
4.5
17.3
0
10
20
30
40
50
60
>2 LineDecrease
2 LineDecrease
1 LineDecrease
NoChange
1 LineIncrease
2 LineIncrease
>2 LineIncrease
% o
f S
ub
ject
s
N=202
UCVA2 year visit
BSCVA2 year visit
0
10099.098.0
88.6
0
20
40
60
80
100
20/20 orbetter
20/25 orbetter
20/30 orbetter
20/40 orbetter
worse than20/40
% o
f S
ub
jects
N=202
0
10099.098.0
88.6
0
20
40
60
80
100
20/20 orbetter
20/25 orbetter
20/30 orbetter
20/40 orbetter
worse than20/40
% o
f S
ub
jects
N=202
2.5
97.593.5
80.5
65.0
0
20
40
60
80
100
20/20 orbetter
20/25 orbetter
20/30 orbetter
20/40 orbetter
worse than20/40
% o
f S
ub
jects
N=200
2.5
97.593.5
80.5
65.0
0
20
40
60
80
100
20/20 orbetter
20/25 orbetter
20/30 orbetter
20/40 orbetter
worse than20/40
% o
f S
ub
jects
N=200
Predictability of Refraction2 years postop
n=199
Mean Spherical
EquivalentPreop to 2 year
-10.41
-0.25 -0.22 -0.23 -0.25 -0.23
-12
-10
-8
-6
-4
-2
0
2
Preop,n=360
1 month,n=359
3 month,n=358
6 month,n=355
1 year,n=334
2 year,n=199
Mea
n S
ph
eric
al E
qu
ival
ent
(D
iop
ter)
78.4
94.0
0
20
40
60
80
100
within ± 0.5 D within ± 1.0 D
% o
f S
ub
jects
J. Colin, MDASCRS 2008
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