PMA P030028

 

 

QUESTIONS FOR PANEL DISCUSSION

 

 

  1. In a paired analysis, the percent change calculated between baseline and 3 years postop was -4.76% with a standard deviation of 7.8%. When analyzed by interval one can see that losses appear to be higher between the second and third postoperative years at -2.37% as compared to the interval between years one and two, -1.12%. The sponsor has presented the following endothelial cell loss data:

 

 

Overall Endothelial Cell Density Results

Cell Count Means

Least Squares Means

Visit

N

Estimate

Standard Deviation

Standard Error

95% Confidence Limits

PreOp

183

2754.2380

357.770

26.4471

2702.4020

2806.0730

6 Months

188

2747.5960

373.622

27.2492

2694.1890

2801.0040

1 Year

240

2711.3210

412.006

26.5949

2659.1960

2763.4460

2 Years

285

2680.1730

445.398

26.3831

2628.4630

2731.8830

3 Years

248

2605.2770

429.856

27.2959

2551.7780

2658.7760

 

Percent Change from Baseline

Least Squares Means

Visit

N

Estimate

Standard Deviation

Standard Error

95% Confidence Limits

6 Months

139

-0.0036

0.068

0.0058

-0.0149

0.0077

1 Year

134

-0.0106

0.068

0.0059

-0.0223

0.0011

2 Years

135

-0.0255

0.074

0.0064

-0.0379

-0.0130

3 Years

107

-0.0476

0.078

0.0075

-0.0623

-0.0328

 

Percent Change by Period

Least Squares Means

Period

N

Estimate

Standard Deviation

Standard Error

95% Confidence Limits

1Y-6M

149

-0.0117

0.062

0.0051

-0.0217

-0.0017

2Y-1Y

198

-0.0112

0.058

0.0041

-0.0192

-0.0033

3Y-2Y

216

-0.0237

0.063

0.0043

-0.0322

-0.0153

6M-BL

139

-0.0039

0.072

0.0061

-0.0158

0.0080

3y-6m

111

-0.0475

0.073

0.0069

-0.0610

-0.0341

 

 

Recount Sub-Study:  All Data

Average Loss Over Time

-49.76 Cells/Year

95% CI = (-60.69, -38.83)

Projected 10 Years

2267.43

Projected 20 Years

1769.81

Projected 30 Years

1272.18

 

 

 

 

 

The endothelial cell loss results for the overall analysis stratified by Anterior Chamber Depth is presented in the following table:

 

 

Overall Endothelial Cell Density Results By Anterior Chamber Depth

Percent Change From Baseline

Least Squares Means

Visit

ACD

N

Estimate

Standard Deviation

Standard Error

95% Confidence Limits

6 Months

3.0 to 3.2mm

8

-0.0234

0.027

0.0095

-0.0421

-0.0048

6 Months

> 3.2 to 3.4mm

20

-0.0288

0.076

0.0171

-0.0623

0.0047

6 Months

> 3.4 to 3.9mm

67

-0.0028

0.059

0.0072

-0.0170

0.0113

6 Months

> 3.9

44

0.0113

0.062

0.0093

-0.0068

0.0295

1 Year

3.0 to 3.2mm

4

-0.0264

0.017

0.0083

-0.0428

-0.0101

1 Year

> 3.2 to 3.4mm

24

-0.0461

0.061

0.0125

-0.0705

-0.0217

1 Year

> 3.4 to 3.9mm

63

0.0031

0.065

0.0082

-0.0131

0.0192

1 Year

> 3.9

43

-0.0087

0.056

0.0085

-0.0254

0.0079

2 Years

3.0 to 3.2mm

8

-0.0076

0.037

0.0131

-0.0333

0.0182

2 Years

> 3.2 to 3.4mm

22

-0.0373

0.076

0.0163

-0.0694

-0.0053

2 Years

> 3.4 to 3.9mm

67

-0.0272

0.068

0.0083

-0.0434

-0.0110

2 Years

> 3.9

38

-0.0197

0.066

0.0107

-0.0406

0.0012

3 Years

3.0 to 3.2mm

6

-0.0916

0.024

0.0098

-0.1108

-0.0725

3 Years

> 3.2 to 3.4mm

21

-0.0572

0.073

0.016

-0.0885

-0.0259

3 Years

> 3.4 to 3.9mm

52

-0.0412

0.079

0.0109

-0.0627

-0.0198

3 Years

> 3.9

28

-0.0471

0.060

0.0113

-0.0692

-0.0249

 

 

 

 

 

 

 

 

 

 

 

 

Overall Endothelial Cell Density Results By Anterior Chamber Depth

Percent Change By Period

Least Squares Means

Period

ACD

N

Estimate

Standard Deviation

Standard Error

95% Confidence Limits

1Y-6M

3.0 to 3.2mm

7

-0.0171

0.018

0.0068

-0.0304

-0.0039

1Y-6M

> 3.2 to 3.4mm

23

-0.0187

0.060

0.0125

-0.0432

0.0058

1Y-6M

> 3.4 to 3.9mm

74

-0.0038

0.066

0.0077

-0.0190

0.0113

1Y-6M

> 3.9

45

-0.0195

0.054

0.0081

-0.0355

-0.0035

2Y-1Y

3.0 to 3.2mm

5

0.0255

0.036

0.0162

-0.0062

0.0573

2Y-1Y

> 3.2 to 3.4mm

30

-0.0046

0.055

0.0101

-0.0245

0.0152

2Y-1Y

> 3.4 to 3.9mm

100

-0.0182

0.051

0.0051

-0.0282

-0.0082

2Y-1Y

> 3.9

63

-0.0056

0.062

0.0078

-0.0210

0.0097

3Y-2Y

3.0 to 3.2mm

5

-0.0774

0.042

0.019

-0.1147

-0.0401

3Y-2Y

> 3.2 to 3.4mm

39

-0.0326

0.072

0.0115

-0.0551

-0.0100

3Y-2Y

> 3.4 to 3.9mm

116

-0.0177

0.058

0.0054

-0.0282

-0.0072

3Y-2Y

> 3.9

56

-0.0242

0.061

0.0081

-0.0401

-0.0083

6M-BL

3.0 to 3.2mm

8

-0.0344

0.048

0.017

-0.0678

-0.0010

6M-BL

> 3.2 to 3.4mm

20

-0.0302

0.110

0.0245

-0.0781

0.0178

6M-BL

> 3.4 to 3.9mm

67

0.0018

0.052

0.0064

-0.0108

0.0143

6M-BL

> 3.9

44

0.0057

0.066

0.0099

-0.0136

0.0250

3Y-6M

3.0 to 3.2mm

7

-0.0899

0.047

0.0177

-0.1246

-0.0552

3Y-6M

> 3.2 to 3.4mm

22

-0.0295

0.068

0.0145

-0.0580

-0.0010

3Y-6M

> 3.4 to 3.9mm

51

-0.0411

0.068

0.0095

-0.0597

-0.0225

3Y-6M

> 3.9

31

-0.0637

0.061

0.011

-0.0853

-0.0421

 

 

 

Change in ECC : Subjects with both 3 & 4 Year Follow-Up

Mean ECC at Preop = 2550

N=27

 

% Loss/Gain

PreOp to 3 years

2.12%

PreOp to 4 years

0.47%

3 years to 4 years

-1.63%

 

 

 

 

 

 

 

  1. Do the endothelial cell data presented above in the overall analysis, stratified

      by anterior chamber depth and the extrapolations over time provide

      reasonable assurance of safety of the Artisan myopia lens?

 

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

 

3.       The proposed statement of indications reads: “The reduction or elimination of myopia in adults with myopia ranging from greater than –5 to less than –20 D with less than 2D of astigmatism at the spectacle plane; Patients with documented stability of refraction for the prior 6 months, as demonstrated by a spherical equivalent change of less than or equal to 0.50D.”

 

 

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),

 

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,   

 

c).   minimum preoperative endothelial cell density?  The outcomes of ECC changes reported in number 1 above could be used to determine acceptable minimum endothelial cell densities.

 

  1. Do the panel members have any additional labeling recommendations?