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“ The ICL Spanish Study Group " IRS Meeting Daniel Elies.

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Presentation on theme: "“ The ICL Spanish Study Group " IRS Meeting Daniel Elies."— Presentation transcript:

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2 “ The ICL Spanish Study Group " IRS Meeting Daniel Elies

3 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

4 ICL Spanish Study Group Dr. Duch “alma mater” Paula Ommerli-Weber Isabel Argelés Elisabeth Jori

5 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

6 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

7 ICL Spanish Study Group More than 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

8 ICL Spanish Study Group Total ICL Myop ICL Hiper ICL Toric _ _

9 ICL Spanish Study Group

10 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.

11 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.

12 ICL Spanish Study Group –4493 eyes –Mean age: (16.57 to 59.19) years –Females = 65.95% –Mean preop Sphere = D (-30 to D) –Mean preop Cyl = D (-7.5 to 0 D) –Mean preop SEQ = D (-30 to D) –Mean ACD = 3.15 mm (2.54 to 4.07 mm) –Mean CT = microns (0.290 to microns) –Mean IOP = 14.23mm Hg (7 to 26 mm Hg) –Mean pupil Diameter = 6.17 mm (2 to 9 mm) –Mean AXL = mm (22.76 to mm)

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

14 ICL Spanish Study Group

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16 426 eyes208 eyes 104 eyes29 eyes

17 ICL Spanish Study Group

18 Stability

19 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 (5 due to opacity, 2 due to exc vault, 2 unknown) Exchanged = 11 (5 due to low vault without opacity, 1 due to opacity, 2 to exc vault asympt, 3 due to exc vault sympt)

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

21 ICL Spanish Study Group

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23 1022 eyes476 eyes 254 eyes80 eyes

24 ICL Spanish Study Group

25 Stability

26 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

27 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)

28 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 change in 7 years * G1 -1 change over time in 7 years –More complications observed in Group 1

29 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

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


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