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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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Pma p030028

PMA P030028

Phakic IOL

for the correction of Myopia


Goals of this panel meeting

Goals of This Panel Meeting


Pma p030028

  • Assess

  • Evaluate

  • Identify


Pma p030028

Assess

  • Risks

  • Benefits


Risks

Risks

  • Operative:

    • Improper Enclavation – 2nd surgical procedures

    • Other as in cataract surgery

    • Cataract Induction/Corneal Damage due to skills of surgeon


Risks1

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


Benefits

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


Evaluate

Evaluate

  • Effectiveness Outcomes

  • Safety Outcomes


Effectiveness outcomes

Effectiveness Outcomes

  • UCVA

  • BSCVA

  • Predictability

  • Stability


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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


Bscva

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


Predictability

±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


Stability for the consistent cohort

±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


Safety outcomes

Safety Outcomes

  • BSCVA – already covered

  • Induced Astigmatism

  • Cells/Flare

  • Corneal Edema

  • Increased IOP/Glaucoma

  • Cataracts

  • ECC loss & Corneal Compromise


Induced astigmatism

Induced Astigmatism

  • 2.4% @ 1 Year

  • 2.0% @ 2 Years

  • 3.5% @ 3 years


Inflammatory responses

Inflammatory Responses

  • Cells & Flare

  • Corneal Edema


Increased iop glaucoma

Increased IOP/Glaucoma

  • Secondary to retained viscoelastic & steroid responses

  • Did not persist beyond the first month

  • Responded to treatment when given


Cataracts

Cataracts

  • Total of 49 lens opacities reported

  • 4 were visually significant :

    • 3 required extraction

    • 1 lost 2 lines of BSCVA


Ecc loss corneal compromise

ECC loss & Corneal Compromise

  • Corneal Compromise not reported during study

  • ECC loss analysis covered in detail by Dr. Gerry Gray


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Identify

  • Thresholds of critical inclusion criteria to minimize risks

  • Population that may benefit most


Critical thresholds

Critical Thresholds

Thresholds of critical inclusion criteria to minimize risks

Inclusion criteria specify ≥2000 as the lower limit for preop ECC


Projected loss over time assuming linearity preop 2500 cells mm

Projected Loss Over TimeAssuming Linearity/Preop 2500 cells/mm²


Ecc changes vary with acd

ECC Changes vary with ACD


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  • Two models :

    • 5mm and 6mm

  • Directly relate to pupil sizes in mesopic conditions and associated glare & halos


  • Refractive benefits

    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


    Background question 1

    Background Question #1


    Percent change from baseline

    Percent Change from Baseline


    Percent change by period

    Percent Change by Period


    Ecc change over time from baseline anterior chamber depth 3 0 to 3 2mm

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


    Ecc changes 6m to 3 yrs by acd

    ECC Changes 6M to 3 Yrs. by ACD


    Ecc subjects with 3 4 year follow up mean ecc at pre op 2550 n 27

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


    Question 1

    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?


    Question 2

    Question #2

    Do the data presented in the PMA

    provide reasonable assurance of safety?


    Background question 3

    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.”


    Question 3a

    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),


    Question 3b

    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,


    Question 3c

    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.


    Question 4

    Question #4

    Do the panel members have any

    additional labeling recommendations?


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