The ICL Spanish Study Group IRS Meeting Daniel

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“ The ICL Spanish Study Group " IRS Meeting Daniel Elies

“ The ICL Spanish Study Group " IRS Meeting Daniel Elies

ICL Spanish Study Group • Multicenter, retrospective study of ICL results in Spain •

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

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

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 • 1 th implantations in 1996 – Dr Coret (Nov

ICL Spanish Study Group • 1 th implantations in 1996 – Dr Coret (Nov ‘ 96) – Dr Fdo Castanera – Dr José L Güell • 1 th 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 •

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

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

ICL Spanish Study Group

ICL Spanish Study Group • Retrospective study of 2384 patient: – 4493 eyes which

ICL Spanish Study Group • Retrospective study of 2384 patient: – 4493 eyes which received ICL (V 4) – from August 1998 until September 2007 • Data collected: – – – Demographic Preoperative data PI’s number and tecnique Surgical data Post-operative data Follow-up visits: 1 d, 1 w, 1 m & 1, 3, 5 and 7 y.

ICL Spanish Study Group Statistical analysis: – Group of eyes which met the Indications

ICL Spanish Study Group Statistical analysis: – Group of eyes which met the Indications for Use by STAAR Surgical: • Age (21 -45) , ACD (≥ 2. 8 mm), myopia (-2 to -20. 5) and < 1 D 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.

ICL Spanish Study Group – – – 4493 eyes Mean age: 33. 98 (16. 57 to 59. 19) years Females = 65. 95% Mean preop Sphere = -10. 71 D (-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. 23 mm 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 682 eyes 426 eyes 12 months postop OVERCORRECTED UNDERCORRECTED

ICL Spanish Study Group 682 eyes 426 eyes 12 months postop OVERCORRECTED UNDERCORRECTED

ICL Spanish Study Group

ICL Spanish Study Group

ICL Spanish Study Group

ICL Spanish Study Group

ICL Spanish Study Group 426 eyes 208 eyes 104 eyes 29 eyes

ICL Spanish Study Group 426 eyes 208 eyes 104 eyes 29 eyes

ICL Spanish Study Group

ICL Spanish Study Group

ICL Spanish Study Group • Stability

ICL Spanish Study Group • Stability

ICL Spanish Study Group • Group 0: 1750 eyes Complications – At the time

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 (< 6 mo) = 0 Late opacities (> 6 mo) = 11 (8 mo to 78 mo) – 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 1593 eyes 1024 eyes 12 months postop OVERCORRECTED UNDERCORRECTED

ICL Spanish Study Group 1593 eyes 1024 eyes 12 months postop OVERCORRECTED UNDERCORRECTED

ICL Spanish Study Group

ICL Spanish Study Group

ICL Spanish Study Group

ICL Spanish Study Group

ICL Spanish Study Group 1022 eyes 476 eyes 254 eyes 80 eyes

ICL Spanish Study Group 1022 eyes 476 eyes 254 eyes 80 eyes

ICL Spanish Study Group

ICL Spanish Study Group

ICL Spanish Study Group Stability

ICL Spanish Study Group Stability

ICL Spanish Study Group • Group 1 : 2548 eyes Complications • At the

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) –

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 (< 6 mo) = 3 (1 to 5 mo) • Late opacities (> 6 mo) = 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

ICL Spanish Study Group – Both groups show a tendency to undercorrection (target and cyl migth be the reasons). – Stability: Excellent stability in both groups. * G 0 -0. 6 change in 7 years * G 1 -1 change over time in 7 years – More complications observed in Group 1

ICL Spanish Study Group – Opacities G 0 (3%, only 0. 6% clinically significant)

ICL Spanish Study Group – Opacities G 0 (3%, only 0. 6% clinically significant) – Opacities G 1 (4. 4%, only 1. 7% clinically significant) – Over/undersizing secondary interventions 12 G 0 versus 16 in G 1 – Explanted 9 in G 0 versus 27 in G 1

ICL Spanish Study Group Overall good predictability, efficacy, safety and stability, and few complications

ICL Spanish Study Group Overall good predictability, efficacy, safety and stability, and few complications