Presentation is loading. Please wait.

Presentation is loading. Please wait.

AcrySof ® ReSTOR ® Apodized Diffractive IOL. What is the AcrySof ® ReSTOR ® IOL? The AcrySof ® ReSTOR ® IOL incorporates an apodized diffractive optic.

Similar presentations


Presentation on theme: "AcrySof ® ReSTOR ® Apodized Diffractive IOL. What is the AcrySof ® ReSTOR ® IOL? The AcrySof ® ReSTOR ® IOL incorporates an apodized diffractive optic."— Presentation transcript:

1 AcrySof ® ReSTOR ® Apodized Diffractive IOL

2 What is the AcrySof ® ReSTOR ® IOL? The AcrySof ® ReSTOR ® IOL incorporates an apodized diffractive optic with refraction to achieve a range of quality vision. The AcrySof ® ReSTOR ® IOL incorporates an apodized diffractive optic with refraction to achieve a range of quality vision.

3 Apodized Diffractive Optic Precise reduction in diffractive step heights from center to periphery of 3.6 mm diameter diffractive region Precise reduction in diffractive step heights from center to periphery of 3.6 mm diameter diffractive region Steps reduce from 1.3 microns to 0.2 microns – precise manufacturing Steps reduce from 1.3 microns to 0.2 microns – precise manufacturing gradual energy blend between powers gradual energy blend between powers Unique to AcrySof ® ReSTOR ® IOL Unique to AcrySof ® ReSTOR ® IOL 3.6 mm 1.5 mm 1.3 micron step Original magnification 80 X

4 Technology of the AcrySof ® ReSTOR ® IOL in “human” terms Thickness of a Human Hair = 60 microns Thickness of a Human Hair = 60 microns Thickness of a Red Blood Cell = 7 microns Thickness of a Red Blood Cell = 7 microns Step Height at periphery of the diffractive portion of the AcrySof® ReSTOR® IOL = 0.2 microns Step Height at periphery of the diffractive portion of the AcrySof® ReSTOR® IOL = 0.2 microns

5 Anatomy of the Apodized Diffractive IOL Step heights decrease peripherally from 1.3 – 0.2 microns A +4.0 add at lens plane equaling +3.2 at spectacle plane Central 3.6 mm diffractive structure

6 Apodized Diffractive IOL 1. Allocate appropriate light energy according to activity and light levels 2. Offer a full range of quality vision 3. Minimize visual disturbances Utilizes diffractive and refractive optics with diffractive apodization to:

7 Minimizing Visual Disturbances Through Apodization Apodization is a gradual reduction or blending of the diffractive step heights. Apodization is a gradual reduction or blending of the diffractive step heights. Optimally manages light energy delivered to the retina because it distributes the appropriate amount of light to near and distant focal points, regardless of the lighting situation. Optimally manages light energy delivered to the retina because it distributes the appropriate amount of light to near and distant focal points, regardless of the lighting situation. Designed to improve image quality while minimizing visual disturbances. Designed to improve image quality while minimizing visual disturbances. from Nikon website

8 Theoretical Total Energy Balance at 550 nm for AcrySof ® ReSTOR ® Apodized Diffractive Optic Smaller steps further out direct less light to near Grossly magnified schematic. Larger steps at lens center divide light equally between two images 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1 123456 Pupil Diameter (mm) @ 550 nm Relative Energy Distance Focus Near Focus

9 Cone threshold ≈0.01

10 Spectacle Freedom Overall Vision Comparative S&E data

11 AcrySof® ReSTOR® IOL FDA Clinical Study Results

12 Strengths of the AcrySof ® ReSTOR ® IOL High quality uncorrected near and distance vision with 20/40 or better intermediate vision without movement of the IOL High quality uncorrected near and distance vision with 20/40 or better intermediate vision without movement of the IOL 80% Overall Spectacle Freedom 80% Overall Spectacle Freedom Nearly 94% of patients would have the lens again Nearly 94% of patients would have the lens again

13 Distance VA Binocular 120-180 Days Postoperative Mean LogMAR VA AcrySof® ReSTOR® IOL (n=457) Control (n=157) Uncorrected Best Corrected 20/20 20/15 20/25

14 Near VA Binocular 120-180 Days Postoperative 20/50 20/40 20/30 20/25 20/20 Mean LogMAR VA Uncorrected Distance Corrected Best Corrected AcrySof® ReSTOR® IOL (n=457) Control (n=157)

15 Binocular Defocus Curve - A Full Range of Vision ®

16 Patient Quality of Life

17 Overall Spectacle Freedom

18 QOL Questionnaire - Binocular To what degree does your vision without glasses limit you to reading labels or prices in supermarkets?

19 QOL Questionnaire - Binocular

20

21 Visual Disturbances 120-180 Days Post-Operative Night Vision Problems HalosGlare ® AcrySof ® ReSTOR ® IOL N=457 Monofocal Control N=156 None/MildModerateSevere

22 Subject Satisfaction

23 Summary of AcrySof ® ReSTOR ® IOL Data indicates the AcrySof ® ReSTOR ® IOL: Data indicates the AcrySof ® ReSTOR ® IOL: Provides excellent near VA without compromising distance VA Provides excellent near VA without compromising distance VA Distance VA (mean uncorrected of 20/20) Near VA (mean uncorrected of 20/25=J1) Increased Spectacle Freedom (80% of patients do not require glasses for daily activities) Increased Spectacle Freedom (80% of patients do not require glasses for daily activities) Provides High Patient Satisfaction (Nearly 94% would have the lens again) Provides High Patient Satisfaction (Nearly 94% would have the lens again)

24 Patient Selection

25 Patient Selection Pre-operative Considerations Considerations Considerations Patients who no longer desire to wear glasses Patients who no longer desire to wear glasses Age – non-Medicare patients Age – non-Medicare patients Functional and occupational requirements Functional and occupational requirements Degree of general alertness Degree of general alertness Ocular pathology Ocular pathology Patients visual demands Patients visual demands Expectation for near vision needs Expectation for near vision needs Qualify for bilateral implants Qualify for bilateral implants

26 Patient Selection Pre-operative Exclusion Criteria Subjective Exclusion Subjective Exclusion Hypercritical patients Hypercritical patients Patients with unrealistic expectations Patients with unrealistic expectations Occupational night drivers Occupational night drivers Medical Exclusion Medical Exclusion >1.0 D of corneal astigmatism >1.0 D of corneal astigmatism Pre-existing ocular pathology Pre-existing ocular pathology Previous refractive patients Previous refractive patients Individuals with a monofocal lens Individuals with a monofocal lens

27 Brief Statement for the AcrySof® ReSTOR® IOL AcrySof® ReSTOR® APODIZED DIFFRACTIVE OPTIC INTRAOCULAR LENS CAUTION: Federal law restricts this device to sale by or on the order of a physician. INDICATIONS: The AcrySof® ReSTOR® Apodized Diffractive Optic Posterior Chamber Intraocular Lens (IOL) is intended for primary implantation for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag. WARNINGS: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Some adverse reactions that have been associated with the implantation of intraocular lenses are: hypopyon, intraocular infection, acute corneal decompensation, macular edema, pupillary block, retinal detachment, and secondary surgical intervention (including but not limited to lens repositioning, biometry error, visual disturbances or patient dissatisfaction). As a result of the multifocality, some visual effects (halos or radial lines around point sources of light at night) may also be expected due to the superposition of focused and unfocused multiple images. A reduction in contrast sensitivity may also be experienced by some patients, especially in low lighting conditions such as driving at night. In order to achieve optimal visual performance with this lens, emmetropia must be targeted. Patients with significant preoperative or expected postoperative astigmatism >1.0D may not achieve optimal visual outcomes. Care should be taken to achieve IOL centration, as lens decentration may result in a patient experiencing visual disturbances under certain lighting conditions. PRECAUTIONS: Do not resterilize; do not store over 45° C; use only sterile irrigating solutions such as BSS® or BSS PLUS® Sterile Intraocular Irrigating Solutions. Clinical studies indicated that posterior capsule opacification (PCO), when present, developed earlier into clinically significant PCO. ATTENTION: Reference the Physician Labeling/Directions for Use for a complete listing of indications, warnings and precautions.

28 Thank You


Download ppt "AcrySof ® ReSTOR ® Apodized Diffractive IOL. What is the AcrySof ® ReSTOR ® IOL? The AcrySof ® ReSTOR ® IOL incorporates an apodized diffractive optic."

Similar presentations


Ads by Google