# Presentation: 128327

## Refractec ViewPointTM CK Systemfor theTreatment of Spherical Hyperopia

- Sheryl Berman, MD
- Medical Officer
- FDA/CDRH/ODE/DOED

## Questions for Panel Consideration

- 1. 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?

## 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?

## Induced Increase in Cylinder Magnitude(% of eyes)

## Induced Change in Vector Cylinder Magnitude(% of eyes)

## Induced Absolute Axis Shift(% of all treated eyes)

## Post-op Cylinder Magnitude(% of eyes)Note: all eyes had baseline cylinder magnitude 0.75D or less

## Effect of Induced Cylinder on Uncorrected Visual Acuity(% of eyes at month 12)

## 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?

## 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?

## Stability of MRSE12-month consistent cohort(n=186)

## Stability of MRSEcohort with 2 consecutive visits

## Accuracy of MRSE

## Question for Panel Consideration

- 4. Are there concerns regarding the increased incidence of visual symptoms from pre-op levels?

## Visual Symptoms with 5% increase over baseline (% eyes with moderate to severe symptoms)

## 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?

## 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

## 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?

## Questions for Panel Consideration

- 1. 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?

## 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?

## 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?

## 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?

## Question for Panel Consideration

- 4. Are there concerns regarding the increased incidence of visual symptoms from pre-op levels?

## 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?

## 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?