![Page 1: Refractec ViewPoint™ CK System for the Treatment of Spherical Hyperopia Sheryl Berman, MD Medical Officer FDA/CDRH/ODE/DOED](https://reader035.vdocument.in/reader035/viewer/2022062409/5697bff11a28abf838cbb6b3/html5/thumbnails/1.jpg)
Refractec ViewPoint™ CK Systemfor the
Treatment of Spherical Hyperopia
Sheryl Berman, MD
Medical Officer
FDA/CDRH/ODE/DOED
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Questions for Panel Consideration1. What are the concerns regarding the incidence of induced cylinder with significant axis shift, and its consequent effect on efficacy?
2. Is 12-month follow-up sufficient to provide reasonable assurance of safety and efficacy? There are 21 eyes available at 24 months. Should data for these eyes also be required in the labeling?
3. Does the refractive correction obtained with this device, in light of the rate of change of mean MRSE over time and the incidence of over- and undercorrection, justify the potential risks?
4. Are there concerns regarding the increased incidence of visual symptoms from pre-op levels?
5. Do the safety and efficacy data presented in this PMA support approval of this device for the requested indication? Is the requested indication appropriate as worded, based on the study outcome?
6. What are your recommendations for labeling regarding regression of effect, induction of cylinder, and incidence of visual symptoms? Are there additional labeling recommendations?
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Question for Panel Consideration
1. What are the concerns regarding the incidence of induced cylinder with significant axis shift, and its consequent effect on efficacy?
![Page 4: Refractec ViewPoint™ CK System for the Treatment of Spherical Hyperopia Sheryl Berman, MD Medical Officer FDA/CDRH/ODE/DOED](https://reader035.vdocument.in/reader035/viewer/2022062409/5697bff11a28abf838cbb6b3/html5/thumbnails/4.jpg)
Induced Increase in Cylinder Magnitude
(% of eyes)
Month 1 Month 3 Month 6 Month 9 Month 121D 34% 26% 24.3% 14.4% 12.3%>1D 21% 15% 14.2% 7.4% 6.4%
>1.5D 9% 5% 4% 2.1% 1.5%2D 6% 3% 2% 1% 1%>2D 3% 2% 1% <1% <1%
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Induced Change in Vector Cylinder Magnitude
(% of eyes)
Month 6 Month 9 Month 121D n/a n/a n/a>1D 25% 18% 16%>1.5D 10% 5% 5%2D n/a n/a n/a>2D 3% 2% 1%
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Induced Absolute Axis Shift(% of all treated eyes)
Month 6 Month 9 Month 12>15 degrees 68% 63% 58%>30 degrees 49% 46% 44%>45 degrees 38% 38% 37%>60 degrees 27% 25% 26%>75 degrees 15% 14% 11%Mean shift(degrees)
37.84 36.58 35.46
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Post-op Cylinder Magnitude(% of eyes)
Note: all eyes had baseline cylinder magnitude 0.75D or less
Month 6 Month 9 Month 121D 40% 29% 32%
1.5D 14% 7% 7%2D 5% 2% 3%
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Effect of Induced Cylinder on Uncorrected Visual Acuity
(% of eyes at month 12)
Eyes with<1D induced
cylinder
Eyes with1D induced
cylinderUCVA 20/20 51% 24%UCVA 20/25 74% 48%UCVA 20/40 92% 76%Mean UCVA 20/27 20/33
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Question for Panel Consideration
2. Is 12-month follow-up sufficient to provide reasonable assurance of safety and efficacy? There are 21 eyes available at 24 months. Should data for these eyes also be required in the labeling?
![Page 10: Refractec ViewPoint™ CK System for the Treatment of Spherical Hyperopia Sheryl Berman, MD Medical Officer FDA/CDRH/ODE/DOED](https://reader035.vdocument.in/reader035/viewer/2022062409/5697bff11a28abf838cbb6b3/html5/thumbnails/10.jpg)
Question for Panel Consideration
3. Does the refractive correction obtained with this device, in light of the rate of change of mean MRSE over time and the incidence of over- and undercorrection, justify the potential risks?
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Stability of MRSE12-month consistent cohort
(n=186)
Month 3 - 6 Month 6 - 9 Month 9 - 12Change MRSE 1D 94% 98% 97%Mean change (MD)paired difference
0.31D 0.08D 0.12D
Extrapolatedannual change
1.24D 0.32D 0.48D
95% CI 0.23, 0.39 0.02, 0.14 0.06, 0.18
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Stability of MRSEcohort with 2 consecutive visits
Month 3 – 6N=381
Month 6 – 9N=370
Month 9 – 12N=195
Change MRSE 1D 93% 98% 97%Mean change (MD)paired difference
0.26D 0.09D 0.13D
Extrapolatedannual change
1.04D 0.36D 0.52D
95% CI 0.20, 0.32 0.05, 0.13 0.07, 0.19
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Accuracy of MRSE
Month 1 Month 3 Month 6 Month 9 Month 12
Undercorrection>1D 3% 3% 6% 8% 6%>2D <1% 1% <1% 1% 1%
Overcorrection>1D 23% 13% 6% 5% 2%>2D 6% 2% 1% 1% 0%
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Question for Panel Consideration
4. Are there concerns regarding the increased incidence of visual symptoms from pre-op levels?
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Visual Symptoms with 5% increase over baseline
(% eyes with moderate to severe symptoms)
Pre-op Month 6 Month 9 Month 12Dryness (marked) 1% 6% 5% 2%Halos (moderate) 2% 8% 9% 9%Diplopia (marked) 1% 6% 5% 3%Fluctuation inVision (moderate)
3% 8% 7% 8%Fluctuation inVision (marked)
1% 7% 5% 3%Glare (moderate) 6% 11% 8% 11%Variation in visionin normal light(moderate)
4% 9% 8% 6%
Variation in visionin dim light(moderate)
8% 13% 12% 11%
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Question for Panel Consideration
5. Do the safety and efficacy data presented in this PMA support approval of this device for the requested indication? Is the requested indication appropriate as worded, based on the study outcome?
![Page 17: Refractec ViewPoint™ CK System for the Treatment of Spherical Hyperopia Sheryl Berman, MD Medical Officer FDA/CDRH/ODE/DOED](https://reader035.vdocument.in/reader035/viewer/2022062409/5697bff11a28abf838cbb6b3/html5/thumbnails/17.jpg)
Requested Indication for Use
• CK treatment for the reduction of spherical hyperopia in the range of:• +0.75 to +3.25 D of cycloplegic spherical hyperopia• -0.75 D or less of refractive astigmatism• +0.75 to +3.00 D cycloplegic spherical equivalent
• In patients with 0.50 D difference between preoperative manifest and cycloplegic refractions
• In patients 40 years of age or older • The magnitude of correction diminishes over time with an
average loss of approximately 10% of the intended correction at one year
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Question for Panel Consideration
6. What are your recommendations for labeling regarding regression of effect, induction of cylinder, and incidence of visual symptoms? Are there additional labeling recommendations?
![Page 19: Refractec ViewPoint™ CK System for the Treatment of Spherical Hyperopia Sheryl Berman, MD Medical Officer FDA/CDRH/ODE/DOED](https://reader035.vdocument.in/reader035/viewer/2022062409/5697bff11a28abf838cbb6b3/html5/thumbnails/19.jpg)
Questions for Panel Consideration1. What are the concerns regarding the incidence of induced cylinder with significant axis shift, and its consequent effect on efficacy?
2. Is 12-month follow-up sufficient to provide reasonable assurance of safety and efficacy? There are 21 eyes available at 24 months. Should data for these eyes also be required in the labeling?
3. Does the refractive correction obtained with this device, in light of the rate of change of mean MRSE over time and the incidence of over- and undercorrection, justify the potential risks?
4. Are there concerns regarding the increased incidence of visual symptoms from pre-op levels?
5. Do the safety and efficacy data presented in this PMA support approval of this device for the requested indication? Is the requested indication appropriate as worded, based on the study outcome?
6. What are your recommendations for labeling regarding regression of effect, induction of cylinder, and incidence of visual symptoms? Are there additional labeling recommendations?
![Page 20: Refractec ViewPoint™ CK System for the Treatment of Spherical Hyperopia Sheryl Berman, MD Medical Officer FDA/CDRH/ODE/DOED](https://reader035.vdocument.in/reader035/viewer/2022062409/5697bff11a28abf838cbb6b3/html5/thumbnails/20.jpg)
Question for Panel Consideration
1. What are the concerns regarding the incidence of induced cylinder with significant axis shift, and its consequent effect on efficacy?
![Page 21: Refractec ViewPoint™ CK System for the Treatment of Spherical Hyperopia Sheryl Berman, MD Medical Officer FDA/CDRH/ODE/DOED](https://reader035.vdocument.in/reader035/viewer/2022062409/5697bff11a28abf838cbb6b3/html5/thumbnails/21.jpg)
Question for Panel Consideration
2. Is 12-month follow-up sufficient to provide reasonable assurance of safety and efficacy? There are 21 eyes available at 24 months. Should data for these eyes also be required in the labeling?
![Page 22: Refractec ViewPoint™ CK System for the Treatment of Spherical Hyperopia Sheryl Berman, MD Medical Officer FDA/CDRH/ODE/DOED](https://reader035.vdocument.in/reader035/viewer/2022062409/5697bff11a28abf838cbb6b3/html5/thumbnails/22.jpg)
Question for Panel Consideration
3. Does the refractive correction obtained with this device, in light of the rate of change of mean MRSE over time and the incidence of over- and undercorrection, justify the potential risks?
![Page 23: Refractec ViewPoint™ CK System for the Treatment of Spherical Hyperopia Sheryl Berman, MD Medical Officer FDA/CDRH/ODE/DOED](https://reader035.vdocument.in/reader035/viewer/2022062409/5697bff11a28abf838cbb6b3/html5/thumbnails/23.jpg)
Question for Panel Consideration
4. Are there concerns regarding the increased incidence of visual symptoms from pre-op levels?
![Page 24: Refractec ViewPoint™ CK System for the Treatment of Spherical Hyperopia Sheryl Berman, MD Medical Officer FDA/CDRH/ODE/DOED](https://reader035.vdocument.in/reader035/viewer/2022062409/5697bff11a28abf838cbb6b3/html5/thumbnails/24.jpg)
Question for Panel Consideration
5. Do the safety and efficacy data presented in this PMA support approval of this device for the requested indication? Is the requested indication appropriate as worded, based on the study outcome?
![Page 25: Refractec ViewPoint™ CK System for the Treatment of Spherical Hyperopia Sheryl Berman, MD Medical Officer FDA/CDRH/ODE/DOED](https://reader035.vdocument.in/reader035/viewer/2022062409/5697bff11a28abf838cbb6b3/html5/thumbnails/25.jpg)
Question for Panel Consideration
6. What are your recommendations for labeling regarding regression of effect, induction of cylinder, and incidence of visual symptoms? Are there additional labeling recommendations?