Transcript The ICL Spanish Study Group - Punto de Encuentro Oftalmológico

“ The ICL Spanish
Study Group "
IRS Meeting
Daniel Elies
ICL Spanish Study Group
• Multicenter, retrospective study of
ICL results in Spain
• Spain is the country with largest
number of implants & one with the
longest experience
ICL Spanish Study Group
• Dr. Duch “alma
mater”
• Paula Ommerli-Weber
• Isabel Argelés
• Elisabeth Jori
ICL Spanish Study Group
José Alfonso Sanchez
Jaime Aramberri
Pedro Caro
Jorge Castanera
Andreu Coret
Francesc Duch
Daniel Elies
Juan Pedro Torralba
IO Fdez-Vega
BEGITEK
Oculsur
I Castanera
USP-IOB
ICR
IMO
Oculsur
ICL Spanish Study Group
• 1th implantations in 1996
– Dr Coret (Nov ‘96)
– Dr Fdo Castanera
– Dr José L Güell
• 1th trainners
– Dr Coret
– Dr Fdo Castanera
– Dr Jorge Castanera
– Dr Jimenez-Alfaro
– Dr Elies
– Dr Torralba
ICL Spanish Study Group
• More than 20.000 ICLs
implanted in Spain
• 308 ophthalmologists
• More than 500 implants (sep ‘07)
– USP-IOB  2940
– IO Fdez-Vega  1232
– Cl. Baviera  732
– Begitek  503
– ICR  499
ICL Spanish Study Group
2000 2001
ICL
2002
2003
2004
2005
2006
2007
Total
830 1225 1585 1593 2416 2723 3263 2797 16432
Myop
ICL
101
142
135
131
208
220
297
305
1539
__
__
__
68
184
400
613
628
1893
Hiper
ICL
Toric
ICL Spanish Study Group
3500
TICL
3000
ICH
ICM
2500
2000
1500
1000
500
0
2000
2001
2002
2003
2004
2005
2006
2007
(Set)
ICL Spanish Study Group
• Retrospective study of 2384 patient:
– 4493 eyes which received ICL (V4)
– from August 1998 until September 2007
• Data collected:
–
–
–
–
–
–
Demographic
Preoperative data
PI’s number and tecnique
Surgical data
Post-operative data
Follow-up visits: 1d, 1w, 1 m & 1,3,5 and 7 y.
ICL Spanish Study Group
Statistical analysis:
– Group of eyes which met the Indications for Use by
STAAR Surgical:
• Age (21-45) , ACD (≥ 2.8mm), myopia (-2 to -20.5) and < 1D
cyl and without pre-existing ocular pathology or ocular surgery.
– Group of eyes which did not meet the Indications for Use
by STAAR Surgical.
ICL Spanish Study Group
–
–
–
–
–
–
–
–
–
–
–
4493 eyes
Mean age: 33.98 (16.57 to 59.19) years
Females = 65.95%
Mean preop Sphere = -10.71D (-30 to -0.50 D)
Mean preop Cyl = -1.43 D (-7.5 to 0 D)
Mean preop SEQ = -11.43 D (-30 to -1.25 D)
Mean ACD = 3.15 mm (2.54 to 4.07 mm)
Mean CT = 0.526 microns (0.290 to 0.700 microns)
Mean IOP = 14.23mm Hg (7 to 26 mm Hg)
Mean pupil Diameter = 6.17 mm (2 to 9 mm)
Mean AXL = 27.71 mm (22.76 to 36.32 mm)
ICL Spanish Study Group
Attempted vs Achieved SEQ (1y). Group 0.
Attempted vs achieved SEQ (1m). Group 0.
Attempted (D)
Attempted (D)
-25
-15
682 eyes
-20
12 months postop
OVERCORRECTED
Achieved (D)
-20
-10
-15
426 eyes
12 months postop
OVERCORRECTED
-10
UNDERCORRECTED
UNDERCORRECTED
-5
0
-5
-5
0
Achieved (D)
-25
-10
-15
-20
-25
-5
0
0
-10
-15
-20
-25
ICL Spanish Study Group
100
100
90
80
79
Cumulative Percent
60
46
40
20
0
16,00
20,00
Snellen VA pre (20/_)
25,00
30,00
40,00
ICL Spanish Study Group
100
98
100
100
100
98
99
100
100
30,00
40,00
50,00
100,00
94
93
80
80
60
40
40
Cumulative Percent
Cumulative Percent
70
60
20
0
16,00
20,00
25,00
30,00
40,00
61
20
0
100,00
20,00
Snellen VA (20/_) (1y)
25,00
Snellen VA (20/_) (3y)
100
99
99
100
100
100
92
91
80
83
80
94
83
60
60
40
40
Cumulative Percent
Cumulative Percent
78
33
20
0
20,00
25,00
Snellen VA (20/_) (5y)
30,00
40,00
50,00
100,00
31
20
0
20,00
25,00
Snellen VA (20/_) (7y)
30,00
40,00
80,00
100,00
ICL Spanish Study Group
SEQ (3y)
SEQ (1y)
40
60
50
35
50
30
29
40
30
426 eyes
20
20
208 eyes
21
22
Percent
Percent
10
14
10
9
0
<-3.1
-2 to -1.1
-3 to -2.1
-0.5 to 0
-1 to -0,51
8
5
+0.01 to +0.5
3
0
+0.51 to +1
-3 to -2.1
+1.1 to +2
-1 to -0,51
-2 to -1.1
SEQ (1y)
+0.01 to +0.5
-0.5 to 0
+0.51 to +1
SEQ (3y)
SEQ (7y)
SEQ (5y)
40
40
38
35
34
30
30
104 eyes
29 eyes
24
20
20
17
17
10
6
5
0
<-3.1
-2 to -1.1
-3 to -2.1
SEQ (5y)
-0.5 to 0
-1 to -0,51
+0.51 to +1
+0.01 to +0.5
+1.1 to +2
Percent
Percent
10
10
7
0
3
<-3.1
SEQ (7y)
-3 to -2.1
-2 to -1.1
-1 to -0,51
-0.5 to 0 +0.01 to +0.5
ICL Spanish Study Group
Change in Snellen lines of VA (1y)
60
Change in Snellen lines of VA (1y)
50
51
Valid
40
30
28
Percent
20
14
10
4
0
-2
-1
0
+1
+2
Change in Snellen lines of VA (1y)
+3
+4
>+5
-2
-1
0
+1
+2
+3
+4
>+5
Total
Frequency
5
423
232
117
34
16
9
1
837
Valid Percent
,6
50,5
27,7
14,0
4,1
1,9
1,1
,1
100,0
ICL Spanish Study Group
• Stability
SEQ evolution. Group 0.
0
-0,2
1m
1y
3y
5y
7y
SEQ (D)
-0,4
-0,6
-0,8
n=682
n=426
n=208
-1
n=104
-1,2
-1,4
-1,6
Time
n=29
ICL Spanish Study Group
• Group 0: 1750 eyes Complications
– At the time of surgery: 0 eyes
– 1 day:
•
•
•
•
•
•
Angle closure = 3 eyes
Pup block = 1 eye
Elevated IOP = 3 eyes
Inflammation = 1
Excessive vault=1
PI too small = 1
– Lens opacities (from 1 Day to last visit)
•
•
•
•
Trace = 42 eyes (2.4%), required phaco+IOL= 6 (0.32%)
Clinically Significant = 11 eyes (0.6%), which required Phaco+IOL = 11
Early opacites (< 6mo) = 0
Late opacities (> 6mo) = 11 (8mo to 78mo)
– Size related (from 1 Day to last visit)
• Excessive = 7
• Inadequate = 5
– Secondary interventions to remove/exchange/reposition ICL:
• Explanted = 9
• Exchanged = 11
(5 due to opacity, 2 due to exc vault, 2 unknown)
(5 due to low vault without opacity, 1 due to opacity, 2 to
exc vault asympt, 3 due to exc vault sympt)
ICL Spanish Study Group
Attempted vs Achieved SEQ (1m). Group 1.
Attempted vs Achieved SEQ (1y). Group 1.
Attempted (D)
Attempted (D)
-30
1593 eyes
-27
12 months postop
-20
-22
Achieved (D)
OVERCORRECTED
-15
-10
1024 eyes
12 months postop
OVERCORRECTED
Achieved (D)
-25
-32
-17
-12
-5
UNDERCORRECTED
-5
0
-10
-15
-20
-25
-30
UNDERCORRECTED
-7
0
-2-2
5
-7
-12
-17
-22
-27
-32
ICL Spanish Study Group
100
93
93
97
100
100
100
86
80
67
60
Cumulative Percent
52
40
20
17
0
12,50
25,00
20,00
40,00
30,00
Snellen VA pre (20/_)
60,00
50,00
100,00
80,00
200,00
400,00
ICL Spanish Study Group
100
95
97
98
100
100
100
100
94
85
80
80
96
99
98
100
100
82
72
69
60
Cumulative Percent
Cumulative Percent
60
40
34
20
0
20,00
30,00
25,00
50,00
40,00
100,00
80,00
40
30
20
0
400,00
10,00
200,00
25,00
20,00
Snellen VA (20/_) (1y)
40,00
30,00
200,00
100,00
400,00
Snellen VA (20/_) (3y)
100
99
92
100
99
100
94
99
100
100,00
400,00
94
90
87
80
80,00
50,00
85
80
75
67
60
60
49
40
20
19
0
20,00
30,00
25,00
Snellen VA (20/_) (5y)
50,00
40,00
100,00
80,00
Cumulative Percent
Cumulative Percent
56
200,00
40
20
13
400,00
0
20,00
25,00
30,00
Snellen VA (20/_) (7y)
40,00
50,00
80,00
ICL Spanish Study Group
SEQ (3y)
SEQ (1y)
40
50
40
42
30
1022 eyes
31
476 eyes
25
30
20
20
21
21
10
Percent
Percent
17
14
10
3
0
<-3.1
-2 to -1.1
-3 to -2.1
-0.5 to 0
-1 to -0,51
+0.51 to +1
+0.01 to +0.5
10
7
0
3
<-3.1
>+3.1
-2 to -1.1
-3 to -2.1
+1.1 to +2
-0.5 to 0
-1 to -0,51
+0.51 to +1
+0.01 to +0.5
>+3.1
+1.1 to +2
SEQ (3y)
SEQ (1y)
SEQ (7y)
SEQ (5y)
40
30
254 eyes
30
80 eyes
24
31
20
21
19
23
20
20
15
10
11
Percent
Percent
10
13
7
5
2
0
<-3.1
-2 to -1.1
-3 to -2.1
SEQ (5y)
-0.5 to 0
-1 to -0,51
+0.51 to +1
+0.01 to +0.5
8
0
<-3.1
+1.1 to +2
-2 to -1.1
-3 to -2.1
SEQ (7y)
-0.5 to 0
-1 to -0,51
+1.1 to +2
+0.01 to +0.5
ICL Spanish Study Group
Change in Snellen lines of VA (1y)
40
Change in Snellen lines of VA (1y)
37
Valid
32
30
20
17
Percent
10
5
4
0
<-5
-4
-3
-2
-1
0
Change in Snellen lines of VA (1y)
+1
+2
+3
+4
>+5
<-5
-4
-3
-2
-1
0
+1
+2
+3
+4
>+5
Total
Frequency
4
5
3
6
456
398
208
66
55
19
14
1234
Valid Percent
,3
,4
,2
,5
37,0
32,3
16,9
5,3
4,5
1,5
1,1
100,0
ICL Spanish Study Group
Stability
SEQ evolution. Group 1.
0
1m
1y
3y
5y
7y
SEQ (D)
-0,5
n=1024
-1
n=1583
n=476
-1,5
n=254
-2
Time
n=80
ICL Spanish Study Group
• Group 1 : 2548 eyes Complications
• At the time of surgery:
–
–
–
–
–
–
ICL upside-down = 1
Iris hemorrage = 1
Intraoperative miosis =1
Luxation of ICL = 1
Need post-surgical PI = 1
Excessive vault = 1
• 1 Day:
–
–
–
–
Angle closure = 5
Pupil block = 5
Crystalline touch = 3
Hyphema = 1
ICL Spanish Study Group
•
Lens opacities: (from 1 Day to last visit)
– Trace = 69 eyes (2.7%), required phaco + IOL = 12
– Clinically significant= 44 (1.7%), required phaco + IOL= 24
• Early opacites (< 6mo) = 3 (1 to 5 mo)
• Late opacities (> 6mo) = 41 (9 to 104 mo)
• Age distribution for each group of early vs late =33,09 (31,99 to 33,63) vs
38,47 (23,73 to 49,45)
• Size related (from 1 Day to last visit)
– Excessive = 13 (3 explanted/10 exchanged)
– Inadequate = 3 (1 explanted/2 exchanged)
• Secondary interventions to remove/exchange/reposition ICL:
– Explanted = 27 (20 due to opacity, 3 exc vault symptom, 1 low vault
without opacity, 3 unknown)
– Exchanged = 19 (8 exc vault sympt, 2 exc vault asympt, 2 low vault
without opacity, 2 opacities, 3 sublux/dislocation, 2 unknown)
– Repositioned = 1 (due to trauma)
ICL Spanish Study Group
– Both groups show a tendency to undercorrection
(target and cyl migth be the reasons).
– Stability: Excellent stability in both groups.
* G0 -0.6 change in 7 years
* G1 -1 change over time in 7 years
– More complications observed in Group 1
ICL Spanish Study Group
– Opacities G0 (3%, only 0.6% clinically significant)
– Opacities G1 (4.4%, only 1.7% clinically significant)
– Over/undersizing secondary interventions
12 G0 versus 16 in G1
– Explanted 9 in G0 versus 27 in G1
ICL Spanish Study Group
Overall good predictability,
efficacy, safety and stability, and
few complications