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1 Clinical Performance of the Crystalens® AO Guy M. Kezirian, MD, FACS.

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Presentation on theme: "1 Clinical Performance of the Crystalens® AO Guy M. Kezirian, MD, FACS."— Presentation transcript:

1 1 Clinical Performance of the Crystalens® AO Guy M. Kezirian, MD, FACS

2 2 Disclosures The presenter is –A paid consultant to Bausch & Lomb –Owner of SurgiVision® Consultants, Inc. Provides DataLink IOL Edition for B&L surgeons Data in this report are taken from DataLink IOL Edition –An Online IOL Registry - not a study Data in this report have not been audited

3 3 Crystalens AO (Aspheric Optic) 3 rd IOL in a series of 5.0 mm optics lenses in the Crystalens series 1.Five-O –Square edge design, new haptic configuration 2.HD –Added a 2 mm “Blended bi-spheric” central optic –Net result is mild asphericity to increase near vision 3.AO –Smooth, aspheric optic designed to be less sensitive to small decentrations –FDA Approved 10-23-2009

4 4 Available Powers: Crystalens AO 10.0 to 33.0 D in 0.50-D steps 18 - 22 in 0.25-D steps Crystalens HD 10.0 to 33.0 D in 0.50-D steps 18.0 to 22.75 D in 0.25-D steps Crystalens Five-O 4.0 to 9.0 D in 1-D steps 10.0 to 16.0 D in 0.50-D steps 16.25 to 26.75 D in 0.25-D steps 27.0 to 33.0 D in 0.50-D steps Crystalens AO Product Specifications Only: Diameter:5.0 mm Shape: Biconvex Material:Biosil ® Recommended Starting A Constant: AO 119.1 Recommended Starting ACD: 5.61 mm Overall length:AT50AO 11.5 mm (17.0 to 33.0 D) AT52AO 12.0 mm (10.0 to 16.5 D) 4/10/2010 Guy M. Kezirian, MD, FACS

5 5 Methods DataLink IOL Edition is an online registry available to all Crystalens users This report evaluates AO outcomes –Based on single procedure outcomes, only –Operated December, 2009 – September, 2010 Eligibility Criteria –Excluded eyes with preop pathology, prior LASIK, extreme axial lengths ( 28) –Required complete postop data (Distance / Near / Refraction) –Exam required to be greater than 3 weeks from surgery –Eyes with reported PCO excluded

6 6 Overall, 3,250 AO lenses have been reported into DataLink 76 surgeons contributed 576 eyes that met all the eligibility criteria –Most common exclusions were Fewer than qualifying 5 eyes per surgeon / n = 1,913 Incomplete data (esp. intermediate VA), prior conditions / n = 962 Postop exams for early visits, only (e.g., 1 week postop) / n = 273

7 7 Postop Spheroequivalent Error from Targeted (D) Mean -0.16 ± 0.54 D N = 576 Mean -0.16 ± 0.54 D N = 576

8 8 Average Visual Outcomes Distance Targets (Plano to -0.50 D) N = 402 Worse Better

9 9 UCVA (Rates) Distance Targets (Plano to -0.50 D) N = 402

10 10 Comparison to Prior Crystalens Models (Comparison Data: April 2010 ASCRS) Better

11 11 Comparison to Other IOL’s: Rate of 20/30 or Better Standardized Outcomes Comparison (S.E. ± 1 D / ≤ 1 D Cyl)

12 12 Distance UCVA v. Cylinder Defocus Spheroequivalent within ± 0.25 D

13 13 Discussion This report is based on reliable, complete data sets that met study criteria –Can be used to confirm the results in the general registry, which show similar findings Findings suggest that results with the AO lens are equal or better than prior crystalens models Compared to the ReSTOR Plus 3 and the Tecnis multifocal: –Intermediate acuities are better with the AO –Near acuities are not as good Surgeons should measure and document intermediate acuities as part of the routine postop visit! –Use the VA card made for this purpose The final refractive outcome is critical to the performance of Presby IOLs!

14 14 Thank You Guy M. Kezirian, MD, FACS Guy1000@SurgiVision.net


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