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Multicenter Retrospective Study on ICL Outcomes in Spain: Safety and Efficacy Analysis

This multicenter retrospective study evaluates the outcomes of Implantable Contact Lenses (ICL) across Spain, the leading country in implantations since 1996. Analyzed data from 2,384 patients (4,493 eyes) collected between August 1998 and September 2007 highlights demographics, surgical techniques, and post-operative results. With over 20,000 ICLs implanted and participation from 308 ophthalmologists, the study reveals excellent predictability, efficacy, safety, and stability, demonstrating few complications and a tendency for undercorrection in both evaluated groups.

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Multicenter Retrospective Study on ICL Outcomes in Spain: Safety and Efficacy Analysis

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

  2. Multicenter, retrospective study of ICL results in Spain • Spain is the country with largest number of implants & one with the longest experience

  3. Dr. Duch “alma mater” • Paula Ommerli-Weber • Isabel Argelés • Elisabeth Jori

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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)

  10. 426 eyes 12 months postop 682 eyes 12 months postop OVERCORRECTED OVERCORRECTED UNDERCORRECTED UNDERCORRECTED

  11. 426 eyes 208 eyes 104 eyes 29 eyes

  12. Stability

  13. 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)

  14. 1593 eyes 12 months postop 1024 eyes 12 months postop OVERCORRECTED OVERCORRECTED UNDERCORRECTED UNDERCORRECTED

  15. 1022 eyes 476 eyes 254 eyes 80 eyes

  16. Stability

  17. 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

  18. 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)

  19. 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

  20. 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

  21. Overall good predictability, efficacy, safety and stability, and few complications

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