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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

PMA P030028

Phakic IOL

for the correction of Myopia




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


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


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



  • 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







    Ecc subjects with 3 4 year follow up mean ecc at pre op 2550 n 27
    ∆ECC : Subjects with 3 & 4 Year Follow-Up 3.0 to 3.2mmMean ECC at Pre-Op = 2550N=27


    Question 1
    Question #1 3.0 to 3.2mm

    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 3.0 to 3.2mm

    Do the data presented in the PMA

    provide reasonable assurance of safety?


    Background question 3
    Background Question #3 3.0 to 3.2mm

    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 3.0 to 3.2mm

    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 3.0 to 3.2mm

    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 3.0 to 3.2mm

    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 3.0 to 3.2mm

    Do the panel members have any

    additional labeling recommendations?


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