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EXPERIENCE WITH THE LENSTEC KH3500 TETRAFLEX LENS.

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Presentation on theme: "EXPERIENCE WITH THE LENSTEC KH3500 TETRAFLEX LENS."— Presentation transcript:

1 EXPERIENCE WITH THE LENSTEC KH3500 TETRAFLEX LENS

2 We Compared The Print Sizes On The ETDRS Near Chart To Commonly Read Print Objects What is Functional Near Acuity?

3 ETDRS Near Chart

4 We Couldnt Find ANY Commonly Read Print Objects With Print Size Of 20/40 (6/12) Or Worse What is Functional Near Acuity?

5 Sweetener Packets Between 20/40 And 20/50 (J5-J6)

6 Want Ads 20/50 (J6)

7 Stock Quotations 20/50 (J6)

8 Telephone Directory 20/63 (J8)

9 Standard Newspaper Print 20/80 (J9)

10 Journal/ Magazine Articles 20/80 (J9)

11 TETRAFLEX KH ADVANTAGES PolyHEMA – Highly Biocompatible Large optic – 5.75mm Injectable – Inserted Thru 1.8mm Cartridge Standard Phaco Technique – No Learning Curve Square Edge Design

12 TetraFlex Intended Benefits To Provide Enhanced Distance and Near Vision with an Increased Independence from Corrective Lens Wear

13 International Data Will Be Compared With 1 Month (N = 209) and 6 Month (N = 140) Data Obtained From the U.S. FDA Clinical Trial.

14 International Exclusion Criteria Any subject with a preoperative cylinder of >= 2.5 D (Astigmatism) Any subject with a preoperative cylinder of >= 2.5 D (Astigmatism) Any subject requiring corneal relaxing incisions for treatment of astigmatism Any subject requiring corneal relaxing incisions for treatment of astigmatism Any subject diagnosed with amblyopia preoperatively Any subject diagnosed with amblyopia preoperatively

15 INTERNATIONAL DATA TETRAFLEX A-IOL 95 Eyes In 42 Patients 36 Are Bilaterally Implanted Follow-up at 6 Months or Later is 81%

16 All Eyes- Bilaterally and Unilaterally Implanted

17 International Data Uncorrected Distance Vision

18 US FDA Trial Data Uncorrected Distance Visual Acuity

19 International Data Uncorrected Near Vision

20 US FDA Trial Data Uncorrected Near Visual Acuity Want Ads Telephone Directory Newspaper Print

21 International Data Distance Corrected Near Vision Want Ads Telephone Directory Newspaper Print

22 US FDA Trial Data Distance Corrected Near Vision Want Ads Telephone Directory Newspaper Print

23 International Data Accommodative Amplitude

24 US FDA Trial Data Accommodative Amplitude

25 Bilateral Cases (International) Patients Examined Binocularly

26 International Data Uncorrected Distance Vision

27 International Data Uncorrected Near Vision

28 International Data Distance Corrected Near Vision

29 International Data Accommodative Amplitude

30 SUMMARY Tetraflex Provides Good Distance Vision And Demonstrates Enhanced Near Vision Tetraflex Provides Good Distance Vision And Demonstrates Enhanced Near Vision Performs Best When Implanted Bilaterally Performs Best When Implanted Bilaterally

31 How Do the Distance Corrected Near Acuities With the Tetraflex Compare to Standard Monofocal IOLs? How Do the Distance Corrected Near Acuities With the Tetraflex Compare to Standard Monofocal IOLs?

32 Distance Corrected Near Acuity 1CU vs. ACRYSOF MA 30* * From Heatley et. al. AJO 2005, 140: Want Ads Telephone Directory Newspaper Print

33 Distance Corrected Near Acuity TETRAFLEX vs. 1CU* vs. ACRYSOF MA 30* * From Heatley et. al. AJO 2005, 140: Want Ads Telephone Directory Newspaper Print

34 Distance Corrected Near Acuity TETRAFLEX vs. 1CU* vs. ACRYSOF MA 30* * From Heatley et. al. AJO 2005, 140: Want Ads Newspaper Print Telephone Directory

35 SUMMARY The Tetraflex IOL Provides Enhanced Near Acuity When Compared To Another Accommodative IOL And A Standard Monofocal IOL. It Allows A Large Majority Of Cases To See Commonly Read Small Print Type. The Tetraflex IOL Provides Enhanced Near Acuity When Compared To Another Accommodative IOL And A Standard Monofocal IOL. It Allows A Large Majority Of Cases To See Commonly Read Small Print Type.


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