pma p030028
Download
Skip this Video
Download Presentation
PMA P030028

Loading in 2 Seconds...

play fullscreen
1 / 38

PMA P030028 - PowerPoint PPT Presentation


  • 116 Views
  • Uploaded on

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

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'PMA P030028' - tea


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
pma p030028

PMA P030028

Phakic IOL

for the correction of Myopia

slide3

Assess

  • Evaluate
  • Identify
slide4

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
slide10
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
slide20

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

slide24

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
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?

ad