P030002

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P030002

• CrystaLens Model AT-45
• Multipiece Silicone Posterior Chamber
  Accommodating IOL

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• Bernard P. Lepri, OD, MS, MEd
• Clinical Reviewer
• FDA/DOED

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Information for Question 1
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Accommodative Substudies

• A small subset of five subjects implanted
  bilaterally with the CrystaLens at a single
  clinical site underwent additional testing in an
  effort to document the mechanism of action of the
  CrystaLens, i.e., accommodation achieved by the
  forward and backward movement of the lens optic
  along the axis of the eye.

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• Testing included
• dynamic retinoscopy
• defocus
• near point evaluation
• near vision (DxRx cycloplegia)
• power mapping (Tracey Wavefront)
• anterior chamber depth ( A-scan )
  (cyclopentolate) / 6 pilocarpine.

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Accommodative Substudy Summary (n 10)
Lagenbacher 1.0mm 1.8D
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Correlation of Accommodative Studies

• Abb Vs ACD ? (D)
• Abb. Vs retinoscopy
• Retinoscopy Vs defocus
• Abb. Vs defocus-
• ACD ?(D) Vs defocus

• Rcorr
• 0.662
• -0.54
• 0.07
• 0.01
• 0.07

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Question 1

• This is the first IOL that proposes
  accommodation as its mechanism of action.
• a). Do the effectiveness data support a
  claim of accommodation?
• b). What performance issues should be
  considered both generally and for product
  labeling?

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Information for Question 2

• The stability of the CrystaLens hinge was
  demonstrated by
• a). in-vitro dynamic fatigue testing up to
  1-year
• b). an analysis of change Dx MRSE between
  consecutive examinations
• c). intermediate visual acuity between
  consecutive examinations

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Stability of MRSE Primary Eyes
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(No Transcript)
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Stability of Uncorrected Near Visual Acuity
(UNVA) US Eyes One-Year Consistent Cohort
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Intermediate Visual Acuity Through Distance
Correction (DCIVA) US Eyes
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Question 2

• Do you believe that the sponsor has
  demonstrated the stability of the hinge, and
  therefore the stability of the accommodative
  refractive effect?

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Question 3

• Does the panel recommend any other
• modifications to the proposed
• a). Physician labeling?
• b). Patient labeling?

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Question 4

• Do the data in PMA P030002 support the
  proposed indication statement?

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Indications for use

• Primary implantation for the visual
  correction of aphakia in adult patients with
  cataracts.
• Provide improved near, intermediate, and
  distance vision without spectacles.