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PMA P030028

PMA P030028. Phakic IOL for the correction of Myopia. Goals of This Panel Meeting. Assess Evaluate Identify. Assess. Risks Benefits. Risks. Operative: Improper Enclavation – 2 nd surgical procedures Other as in cataract surgery

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PMA P030028

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  1. PMA P030028 Phakic IOL for the correction of Myopia

  2. Goals of This Panel Meeting

  3. Assess • Evaluate • Identify

  4. Assess • Risks • Benefits

  5. Risks • Operative: • Improper Enclavation – 2nd surgical procedures • Other as in cataract surgery • Cataract Induction/Corneal Damage due to skills of surgeon

  6. Risks • Postoperative • Increased IOP • Iritis (Immediate and Persistent) • Potential for pigmentary glaucoma • Critical Loss of Endothelial cells and corneal function • Retinal Detachment • Dislodgment of IOL

  7. Benefits • Correction of Refractive Error without mitigating optical factors as with spectacle lenses or contact lens complications • Reversibility • Expands the options for correction of moderate to high myopia for those not qualifying/interested in corneal refractive procedures

  8. Evaluate • Effectiveness Outcomes • Safety Outcomes

  9. Effectiveness Outcomes • UCVA • BSCVA • Predictability • Stability

  10. 20/20 or better 1 yr. (n=493) 35.1% 2 yrs. (n=356) 34.6% 3 yrs. (n=231) 31.2% 20/40 or better 86.5% 87.1% 84.0% UCVA

  11. 20/20 or better 1 yr. (n=491) 79% 2 yrs. (n=355) 83% 3 yrs. (n=228) 79% 20/40 or better 99% 100% 100% BSCVA

  12. ±0.50 1 yr. (n=354) 72% 2 yrs. (n=262) 74% 3 yrs. (n=162) 72% ± 1.00 1yr. (465) 94.5% 2yrs. (n=333) 94% 3yrs. (n=214) 95% Predictability

  13. ±0.50 between visits 83% to 87% ± 1.00 between visits 96.2% to 98.2% Mean Differences in refraction between visits ranged from -.02 to -.06 over the 3 year period Stability for the Consistent Cohort

  14. Safety Outcomes • BSCVA – already covered • Induced Astigmatism • Cells/Flare • Corneal Edema • Increased IOP/Glaucoma • Cataracts • ECC loss & Corneal Compromise

  15. Induced Astigmatism • 2.4% @ 1 Year • 2.0% @ 2 Years • 3.5% @ 3 years

  16. Inflammatory Responses • Cells & Flare • Corneal Edema

  17. Increased IOP/Glaucoma • Secondary to retained viscoelastic & steroid responses • Did not persist beyond the first month • Responded to treatment when given

  18. Cataracts • Total of 49 lens opacities reported • 4 were visually significant : • 3 required extraction • 1 lost 2 lines of BSCVA

  19. ECC loss & Corneal Compromise • Corneal Compromise not reported during study • ECC loss analysis covered in detail by Dr. Gerry Gray

  20. Identify • Thresholds of critical inclusion criteria to minimize risks • Population that may benefit most

  21. Critical Thresholds Thresholds of critical inclusion criteria to minimize risks Inclusion criteria specify ≥2000 as the lower limit for preop ECC

  22. Projected Loss Over TimeAssuming Linearity/Preop 2500 cells/mm²

  23. ECC Changes vary with ACD

  24. Two models : • 5mm and 6mm • Directly relate to pupil sizes in mesopic conditions and associated glare & halos

  25. Refractive Benefits The Artisan™ Lens is indicated for the reduction or elimination of myopia in adults with myopia > -5 to < –20 D with less than 2D of astigmatism at the spectacle plane in patients with stable refractive errors. • More alternatives for correction in lower ranges of myopia than in higher ranges

  26. Background Question #1

  27. Percent Change from Baseline

  28. Percent Change by Period

  29. ECC Change Over Time from Baseline Anterior Chamber Depth 3.0 to 3.2mm

  30. ECC Changes 6M to 3 Yrs. by ACD

  31. ∆ECC : Subjects with 3 & 4 Year Follow-UpMean ECC at Pre-Op = 2550N=27

  32. Question #1 Do the endothelial cell data presented above by overall analysis, stratified by anterior chamber depth and the extrapolations over time provide reasonable assurance of safety of the Artisan myopia lens?

  33. Question #2 Do the data presented in the PMA provide reasonable assurance of safety?

  34. Background Question #3 The proposed statement of indications reads: “The reduction or elimination of myopia in adults with myopia > -5 to < –20 D with less than 2D of astigmatism at the spectacle plane; Patients with documented stability of refraction for the prior 6 months, as demon- strated by a spherical equivalent change of ≤0.50D.”

  35. Question 3a Does the panel recommend any modifications to the proposed statement of indications with respect to: a). minimum anterior chamber depth (ACD’s of <3.2 mm were excluded in the study),

  36. Question #3b b). maximum pupil size (the 2 models of Artisan are intended for patients with pupil sizes up to 5.0 mm and up to 6.0 mm); and,

  37. Question #3c c). minimum preoperative endothelial cell density? The outcomes of ECC changes reported in the background data for Question #1 above should be referenced if the panel wishes to recommend an acceptable minimum endothelial cell density to qualify a patient.

  38. Question #4 Do the panel members have any additional labeling recommendations?

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