Dawn of a New Era Modern LASIK Results. Christopher L. Blanton, MD April 28, 2018
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1 Dawn of a New Era Modern LASIK Results Christopher L. Blanton, MD April 28, 2018
2 Financial Disclosure Paid consultant: Johnson & Johnson, Inc.- Star S4/iFS IntraLase Medical Monitor Integra LifeSciences, Inc. One Legacy Organ and Tissue Bank
3 LASIK 2018 Today we are providing the highest quality of vision and excellent visual outcomes with the least amount of symptoms/side effects ever Customized femtosecond flaps: Increase flap creation speed Provide advanced customization parameters to tailor the flap to the patient Improve biomechanical flap stability Customized wavefront-guided treatments: Increase the number of patients to consistently achieve 20/20 or BETTER Help reduce or maintain HOA Reduce enhancement rates
4 Clinical Benefits With IntraLase Reduction of higher-order aberrations 1 Increased quality of vision 2 Reduced enhancement rates 3 Faster recovery in corneal sensitivity 4 may lead to an earlier reduction of postop dry eye symptoms Reduction in most serious, sight-threatening flap complications 5 Consistently creates precise, accurate corneal flaps 1,5 1. Tran DB, Sarayba MA, Bor Z, et al. Randomized prospective clinical study comparing induced aberrations with IntraLase and Hansatome flap creation in fellow eyes: potential impact on wavefront-guided laser in situ keratomileusis. J Cataract Refract Surg. 2005;31(1): Durrie DS, Kezirian GB. Femtosecond laser versus mechanical keratome flaps in wavefront-guided laser in situ keratomileusisj Cataract Refract Surg 2005; 31: Young, M. Fewer retreatments possible with IntraLase. EyeWorld. 2004;9(11). 4. Lim T, et al. Comparison of the IntraLase Femtosecond Laser and Mechanical Microkeratome for Laser In Situ Keratomileusis. Am J Ophthalmol May;141(5): Binder P. 1,000 Consecutive IntraLase LASIK Flaps. J Cataract Refract Surg Jun;32(6):962-9.
5 Flap Creation: Advancements in Customization 5 th Generation Femtosecond Technology: Higher repetition rate Faster flap creation Customized flap shapes (elliptical) Expanded bevel-in side cut angles to 150 Video microscope
6 Summary of Available Excimer Treatment Options Conventional: Early lasers did not consider the importance of asphericity in the ablation contour Led to the induction of high amounts of spherical aberration Less precise, higher enhancement rates Optimized approach: the treatment is based primarily on sphere and cylinder (lower-order aberrations) along with a general population average correction for spherical aberration Wavefront -Guided: Goal to reduce ALL LOAs and HOAs based on each individual s refractive requirements Treatment based on wavefront aberrations Topo-Guided: Utilizes input from topography measurement Most commonly used in eyes with irregular astigmatism or corneal pathology
7 How Common are Higher Order Aberrations? Capt. Scott Barnes, MD US ARMY Captured wavefront on 92 soldiers. 54 (57%) had HOA RMS of 0.3 µm or greater Jack T. Holladay, MD, MSEE, FACS 73% of his patients have greater than 0.21 µm HOA (n=211) Perry S. Binder, MS, MD, San Diego, CA Preoperatively, 46.8% of eyes (1,670/3,568) had HOA RMS of 0.3 µm or greater.
8 WFG and WFO: Outcomes in Myopic Patients Study: Perry Binder, MD Purpose: Compare post-lasik outcomes with wavefront-guided (VISX IR) and wavefront-optimized (Wavelight Allegretto) platforms. Methods: Retrospective analysis of a clinical database of consecutive myopic eyes that underwent LASIK performed by a single surgeon. 72 eyes underwent VISX wavefront-guided (WFG; Fourier/IR) LASIK and 323 eyes underwent wavefront-optimized (WFO) LASIK (Allegretto 200). Binder, Perry. Poster: PreOperative Distribution of HOAs in Patients Undergoing LASIK. ARVO, Ft. Lauderdale, FL.
9 Greater PO HOA RMS with WFO than WFG 1 WFG WFO * 0 Mean RMS (um) 0 0 Pre-op Post-op Post-op RMS was significantly higher in WFO than WFG eyes (P<.001), with WFO eyes experiencing a significant increase in RMS (P<.001). Binder, Perry. Poster: PreOperative Distribution of HOAs in Patients Undergoing LASIK. ARVO, Ft. Lauderdale, FL.
10 Principles of Photodisruption Surgical effect is achieved through Photodisruption at a molecular level No thermal or shock wave transmission to surrounding tissues Laser-Tissue Interactions ArF 193 nm KrF 248 nm XeCl 308 nm XeF 351nm Argon nm Green HeNe 543 nm HeNe 632 nm Diode 680 nm Nd: Yag 1064 nm CO 2 10,600 nm Ultraviolet Visible Infrared Not to Scale 400 nm 750 nm
11 Principles of Photodisruption Excimer ablates upon contact with very short wavelength of ultraviolet light INTRALASE uses much longer wavelength to achieve photodisruption Photoablation: Excimer Photodisruption: Femtosecond Precise Surface Effects Precise Sub-Surface Effects
12 Excimer Laser Photoablation
13 Principles of Photodisruption Laser Induced Optical Breakdown (LIOB) Sharply focused laser pulse of an ultra-short duration generates a plasma Plasma expands and displaces surrounding tissue Cavitation bubble formed
14 Photodisruption A pulse of laser energy is focused to a precise location inside the cornea 1 Micron A microplasma is created, vaporizing approximately 1 micron of corneal tissue
15 Photodisruption The bi-products of photodisruption (CO2 & water) are absorbed by the mechanism of the endothelial pump, leaving a resection plane in the cornea
16 Photodisruption Pulses can be stacked vertically or at an angle
17 Femto LASIK flap Parameter Choices Diameter Thickness Speed Spot/Line Separation Energy Edge Bevel Shape
18 Diameter 8.0 mm Rx sq. mm 9.0 mm Rx-63.6 sq. mm 48.4 sq. mm 41.6 sq. mm 8.5 mm Intralase flap 9.5 mm Hansatome flap
19 Flap thickness- through thick and thin microns
20 I feel the Need for Speed
21 Comparison of Stromal Bed Quality 4th and 5th Generation IntraLase Laser and ZIEMER S FEMTO LDV Laser ZIEMER Femto LDV Laser 4th Generation IntraLase FS Laser 5th Generation ifs Laser M Sarayba, MD D Durrie, MD. Data on file, AMO Development, LLC
22 Inverted Bevel-In Side Cut Angle Higher the side cut angle, the less strain there is on the cornea 1 Bevel-in side cut angle flaps provides the best biomechanical flap strength 1 Flap tensile strength 3x stronger than current microkeratome technology 1,2 Virtually effortless flap lift, replacement and positioning 1 Significantly reduced flap gutter 1 1. Prof M Knorz, U Vossmerbaeumer. Presented ASCRS Prof J Marshall. Presented ASCRS 2008.
23 Round vs. Elliptical Flaps Round Elliptical
24 2011 ifs Study To compare wavefront guided, iris registered LASIK outcomes between a 60 khz femtosecond laser and a 150 khz femtosecond laser
25 Methods 118 myopic eyes underwent an ilasik procedure with 60 khz femtosecond technology 70 degree bevel out flap edge and 9/9 spot line separation 104 myopic eyes underwent the same procedure with 150 khz femtosecond technology 120 degree bevel in flap edge and a 7/7 spot line separation.
26 Methods All exams conducted in our office on calibrated visual acuity charts All procedures were wavefront guided Iris registration with the AMO platform planned on all eyes Standard regimen of fluoroquinolone/prednisolone used Minimum 3 months post-op
27 Outcome Measures UCVA Enhancement rates Iris registration rates Speed of procedure Energy levels Complications
28 Preop Myopic Spherical Equivalent 60 khz: D, Range: D to D 150 khz: D, Range: D to 9.75 D P= 0.898
29 UCVA at Day khz (n=118) 150 khz (n=104) % of Eyes /15 or Better 20/20 or Better P=.906 P=.210
30 UCVA at Month khz (n=74) 150 khz (n=65) 97 % of Eyes /15 or Better 20/20 or Better P=.126 P=.173
31 UCVA at Month khz (n=36) 150 khz (n=21) % of Eyes /15 or Better 20/20 or Better P=.699 P=.649
32 Enhancement Rates 60 khz (n=118): 4.24% 150 khz (n=104): 0% P=0.034
33 Other Results 60 khz 150 khz P-Value Iris Registration 86% 91% Bed Energy (mj) Procedure Speed (sec)
34 Complications 60 khz: 1 patient with bilateral flap dislocations Refloat on postop day 1 Final UCVA- 20/20, 20/15 Preop BCVA- 20/20, 20/ khz: 1 patient with visually significant dry eye Most recent UCVA 20/20
35 Stromal Bed Smoothness 9 x 30 x 135 x 300 x 4 th Generation IntraLase FS Laser 5 th Generation ifs Laser M Sarayba, MD D Durrie, MD. Data on file, AMO Development, LLC
36 Discussion The 150 khz platform allows the surgeon: Faster flap creation Smoother stromal beds Excellent visual outcomes
37 Conclusions 150 khz: Statistically significantly lower enhancement rates Statistically significantly faster speed of procedure Lower energy levels A safer procedure
38 Wavefront Guided- A video is worth a thousand slides
39 Meta-Analysis of LASIK Treatments Dr. Chris Blanton Published in: US Ophthalmic Review,2015;8(1)23-9
40 Meta-Analysis of LASIK Treatments Purpose To perform a comparison analysis of visual outcomes between six common LASIK platforms Abbott-StarS4IR Alcon 200/400 HZ-WFO/WFG Carl Zeiss-Mel 80 Nidek Schwind Technolas-217Z
41 Visual Acuity 1 Month Comparison of Platforms Rank #1 Abbott Rank #1 Abbott** #2 Alcon Rank #1 Abbott** #2 Carl Zeiss #3 Alcon #4 Technolas Rank #1 Abbott** #2 Carl Zeiss* #3 Alcon #4 Technolas #5 Nidek ** Denotes Statistical Significance Over All Successors * Denotes Statistical Significance Over Some Successors
42 Visual Acuity 3 Month Comparison of Platforms Rank #1 Abbott/ Schwind Rank #1 Abbott** #2 Alcon Rank #1 Abbott** #2 Alcon* #3 Schwind* #4 Technolas** #5 Carl Zeiss ** Denotes Statistical Significance Over All Successors * Denotes Statistical Significance Over Some Successors Rank #1 Abbott* #2 Schwind* #3 Carl Zeiss* #4 Nidek* #5 Alcon #6 Technolas
43 Visual Acuity 20/20 Comparison of Platforms Rank #1 Abbott** #2 Carl Zeiss* #3 Alcon #4 Technolas #5 Nidek Rank #1 Abbott* #2 Schwind* #3 Carl Zeiss* #4 Nidek* #5 Alcon #6 Technolas Rank #1 Schwind* #2 Nidek* #3 Carl Zeiss* #4 Alcon #5 Abbott #6 Technolas ** Denotes Statistical Significance Over All Successors * Denotes Statistical Significance Over Some Successors Rank #1 Abbott* #2 Carl Zeiss* #3 Schwind* #4 Alcon* #5 Technolas* #6 Nidek
44 Adverse Event Comparison of Platforms Rank #1 Abbott** #1 Alcon** #3 Carl Zeiss #4 Nidek #4 Technolas Rank #1 Alcon #1 Nidek #1 Carl Zeiss #4 Abbott #5 Schwind #6 Technolas Rank #1 Schwind #1 Abbott #1 Nidek #1 Alcon #5 Carl Zeiss #6 Technolas ** Denotes Statistical Signific # ance Over All Successors * Denotes Statistical Significance Over Some Successors Rank #1 Abbott #1 Carl Zeiss #1 Alcon #4 Nidek #5 Schwind #6 Technolas
45 Outcomes of Wavefront guided LASIK for myopia with and without Iris Registration Christopher L Blanton, M.D.
46 Iris Registration Study Purpose: to compare outcomes in myopic wavefront-guided LASIK with and without iris registration (IR) Methods: retrospective review of 222 consecutive LASIK procedures using wavefront guided technique with femtosecond flap creation with planned IR
47 Data Analysis 222 Eyes 15 eyes- IR not available secondary to: 14- Displaced Outer Iris Boundary (OIB) 1- Iris Nevus
48 Iris Registration WaveScan Acquisition Outer Iris Boundary
49 Surqical Treatment Plan Report Physician: BlantonMD,Christopher Opet ator: Renee Dominciuez Patient: *************.************* Patient ID: Holes: OD DS DC x mm (4.0 Rx Cale) 17-Dec :17:35 W.F. Diam (mm): 6.75 High Order: 10.6 % Eff.Blur (D): 2.76 RmsErr.(µ): 4.53 Quality: Manifest:.J.50 DS DC x mm Limbus Diam:12.5 mm Pupil:7.8 x 7.7 mm@121 (avg 7.8) Cycloplegic: Auto: Auto Cyclo: K1 (D): K2 (D): K2 Axis("): 90 Corneal Thickness (µ): 549 Scotopic Pupil 8 ize (mm): 7.50 Treatment T)'pe:LASIK Correction Type:CustomVue Nomogram Change: Physician Adjustments- SPH (D):.0.60 CYL (D): 0.00 Axis(") VTX(mm) 0.00 Total Correction-SPH (D):.J.10 CYL (D) Al<is("): 0 VTX(mm): 0.00,,,..._... ev. V... I.. S. X... Treatment Parameters _ Distribution of VSS Pulse Diameters 0 ptical Zone (mm): 6.00 x 6.67 "" A blal!on Zone (mm) 8.00 Max. Ablation Depth (µ): 59.2 No. of Tissue Pulses: 312.U.71, Treatment Time (sec): 25.u.:sr Surgical Parameters _ D sr.2, Flap Diameter (mm): s.-5 ff Pulse Diameter (mm) Flap Thickness (µ): 120 2).00, 2u, Residual Bed Depth (µ): Additional Information _ SS.14 Ablaion Oepth(rric:rons) The Manifest and WaveScan refractions do not match Inland EyeLasik Copyright by VISX,Incorporated.
50 Data Analysis
51 LASIK for Myopia With and Without Iris Registration Pre-Op Spherical Equivalent Statistics and Hypothesis Test
52 Iris Registration Basic Principles Comparison of iris images from WaveScan and the STAR S4 IR Laser System WaveScan Image STAR S4 Laser Image Note: - Two different cameras under different lighting - No artificial dilation utilized - Pupil is not symmetrical
53 Bar-code analogy
54 Iris Registration Basic Principles Find multiple matching reference points for each iris section WaveScan Image Laser Image
55 Iris Registration Basic Principles Calculate the torsional angles from multiple measurements Torsional Angle
56 Landmark relationship to pupil
57 Non-captured eyes Iris Detail Lid-Pupil Dist. Large Pupil Indeterminate
58 Surqical Treatment Plan Report Physician: BlantonMD,Christopher Opet ator: Renee Dominciuez Patient: *************.************* Patient ID: Holes: OD DS DC x mm (4.0 Rx Cale) 03-Sep :45:54 W.F. Diam (mm): 7.00 High Order: 5.6 % Eff.Blur (D): 3.80 RmsErr.(µ): 6.71 Quality: Manifest:.J.25 DS DC x mm Limbus Diam:12.8 mm Pupil:7.5 x 7.1 mm@106 (avg 7.3) Cycloplegic:.J.25 DS DC x mm Auto: Auto Cyclo: K1 (D): K2 (D): K2 Axis("): 20 Corneal Thickness (µ): 544 Scotopic Pupil 8 ize (mm): 7.00 Treatment T)'pe:LASIK Correction Type: CustomVue Nomogram Change: Physician Adjustments- SPH (D):.0.30 CYL (D): 0.00 Axis(") VTX(mm) 0.00 Total Correction- SPH (D):.J.09 CYL (D) Al<is("): 98 VTX(mm): 0.00,,,..._... ev. V... I.. S. X... Treatment Parameters _ Distribution of VSS Pulse Diameters 0 ptical Zone (mm): 6.00 x 6.67 "" Ablal!on Zone (mm) 8.00 Max. Ablation Depth (µ): 63.8 No. of Tissue Pulses: 307 Treatment Time (sec): 27 Surgical Parameters _ 4MO Flap Diameter (mm): 9.00 i--ll..j 2 ḻ 3 4ll - + 4(1.:SO s.-5 ff s,.oo t Pulse Diameter (mm) Flap Thickness (µ): 120 Residual Bed Depth (µ): 360 Additional Information _ :S4.00, 4MO St:SO, :SO Ablaion Oepth(rric:rons) Inland EyeLasik Copyright by VISX,Incorporated.
59 Surqical Treatment Plan Report Physician: BlantonMD,Christopher Opet ator: Susan Tardif COA Patient: *************.************* Patient ID: Holes: OS DS.0.77 DC x mm (4.0 Rx Cale) 24.Jun :22:20 W.F. Diam (mm): 7.00 High Order: 3.0 % Eff.Blur (D): 4.94 RmsErr.(µ): 8.73 Quality: Manifest: DS DC x mm Limbus Diam:12.4mm Pupil:7.6 x 7.5 mm@37 (avg 7.5) Cycloplegic: DS DC x mm Auto: Auto Cyclo: K1 (D): K2 (D): K2 Axis("): 70 Corneal Thickness (µ): 534 Scotopic Pupil 8 ize (mm): 5.00 Treatment T)'pe:LASIK Correction Type:CustomVue Nomogram Change: Physician Adjustments- SPH (D):.0.20 CYL (D): 0.00 Axis(") VTX(mm) 0.00 Total Correction- SPH (D): CYL (D).0.68 Al<is("): 153 VTX(mm): 0.00,,,..._... ev. V... I.. S. X... Treatment Parameters _ Distribution of VSS Pulse Diameters 0 ptical Zone (mm): 6.00 x 6.41 "" A blal!on Zone (mm) 8.00 Max. Ablation Depth (µ): 82.3 No. of Tissue Pulses: 369 Treatment Time (sec): t U.21 Surgical Parameters _ $).2) Flap Diameter (mm): 9.00 i- < - 2 Ll > + t.-5 ff $3.SG; Pulse Diameter (mm) Flap Thickness (µ): :SO, Residual Bed Depth (µ): 332 Additional Information _ 41'.4S 3$.$7 2).'4 Ablaion Oepth(rric:rons) Inland Eye Lasik Copyright by VISX,Incorporated.
60 Surqical Treatment Plan Report Physician: BlantonMD,Christopher Opet ator: Susan Tardif COA Patient: *************.************* Patient ID: Holes: OD DS.0.40 DC x mm (4.0 Rx Cale) 09-Sep :36:37 W.F. Diam (mm): 7.00 High Order: 3.1 % Eff.Blur (D): 5.04 Rms Err.(µ): 8.91 Quality: Manifest: DS.0.75 DC x mm Limbus Diam:13.5mm Pupil:8.9 x 8.2 (avg 8.5) Cycloplegic: Auto: Auto Cyclo: K1 (D): K2 (D): K2 Axis("): 94 Corneal Thickness (µ): 554 Scotopic Pupil 8 ize (mm): 5.50 Treatment T)'pe:LASIK Correction Type:CustomVue Nomogram Change: 10% Physician Adjustments- SPH(D): 0.00 CYL (D): 0.00 Axis(") VTX(mm) 0.00 Total Correction- SPH(D): CYL (D).0.35 Al<is("): 17 VTX(mm): 0.00,,,..._... ev. V... I.. S. X... Treatment Parameters _ Distribution of VSS Pulse Diameters 0 ptical Zone (mm): 6.00 x 6.22 "" Ablal!on Zone (mm) 8.00 Max. Ablation Depth (µ): 77.4 No. of Tissue Pulses: 333 Treatment Time (sec): 32 Surgical Parameters _ :Ss.71 ",u,'f. Flap Diameter (mm): 9.00 D i-- < - 2 -i > + t.-5 ff :S0.14 Pulse Diameter (mm) Flap Thickness (µ): 120 3).00, Residual Bed Depth (µ): 357 Additional Information _ '4.57 SS.4S 27.3$ Ablaion Oepth(rric:rons) Inland EyeLasik Copyright by VISX,Incorporated.
61 Enhancement Rates Statistical Analysis of Enhancement Rates With IR Outperfor ms Without IR in terms of En hancement Rates With IR: 0.565% Without IR: 8.889% Difference is Statistically Significant (P-Value =.0060) - Utilizing Fisher s Exact Test
62 Visual Acuity at Day 1 Observations With IR: 177 W/Out IR: 45 Total: 222
63 Visual Acuity at Day 1 Statistical Analysis of LOGMAR Values With IR Outperforms Without IR in terms of Comparison of Means With IR: Without IR: Difference is Not Statistically Significant (P-Value =.3150) - Non-Normality Conditions Exist Utilize Non-Parametric Test (MWU) With IR Displays Less Variation Difference is Not Statistically Significant (P-Val =.2900)
64 Visual Acuity at Week 1 Observations With IR: Observations 177 W/Out With IR: Total: W/Out IR: Total: 210
65 Visual Acuity at Week 1 Statistical Analysis of LOGMAR Values With IR Outperforms Without IR in terms of Comparison of Means With IR: Without IR: Difference is Not Statistically Significant (P-Value =.9700) - Non-Normality Conditions Exist Utilize Non-Parametric Test (MWU) With IR Displays Less Variation Difference is Statistically Significant (P-Val =.0480)
66 Visual Acuity at Month 1 Observations With IR: 130 W/Out IR: 25 Total: 155
67 Visual Acuity at Month 1 Statistical Analysis of LOGMAR Values With IR Outperforms Without IR in terms of Comparison of Means With IR: Without IR: Difference is Not Statistically Significant (P-Value =.8640) - Non-Normality Conditions Exist Utilize Non-Parametric Test (MWU) With IR Displays Less Variation Difference is Statistically Significant (P-Val =.0000)
68 Visual Acuity at Month 3 Observations With IR: 116 W/Out IR: 23 Total: 139
69 Visual Acuity at Month 3 Statistical Analysis of LOGMAR Values With IR and Without IR About Equal in terms of Comparison of Means With IR: Without IR: Difference is Not Statistically Significant (P-Value =.6430) - Non-Normality Conditions Exist Utilize Non-Parametric Test (MWU) With IR Displays Less Variation Difference is Not Statistically Significant (P-Val =.9520)
70 Conclusions IR lowers enhancement rates IR achieves less variability in visual acuity IR tends to achieve better visual acuity quicker
71 Programming Femto Arcuate Incisions
72 Programming Arcuate Incisions The following parameters must be defined to perform Arcuate Incisions Posterior Depth (in microns) Diameter (in millimeters) Energy (in microjoules) Cut Position (1 & 2) Cut Angle (1 & 2) Side Cut Angle (in degrees) Depth in Glass (Penetrating vs Intrastroma l) The following slides will describe in detail how to program these parameters
73 Programming Arcuate Incisions Posterior Depth Example Thinnest pachymetry over area where Arcuate Incision to be placed is 650 microns Subtract 125 microns from thinnest pachymetry over area where Arcuate Incision to be placed: = 525 microns Posterior Depth= 525 microns
74 Programming Arcuate Incisions Diameter - Represents twice the distance from the center of the cross hairs to the incision The programmable diameter can not exceed 9.5mm with a Side Cut Angle of 90 degrees or less The diameter is referenced from the anterior surface and an inverted angle will extend the posterior cut beyond 9.5mm Diameter
75 Programming Arcuate Incisions Cut Position 2 270º 0º 180º 90º Cut Position 1 Cut Position - Placement of the arcuate incision is done by assigning a position (0º to 359º) Cut position represents the location of the arc s midpoint (using a complete circle as a reference)
76 Programming Arcuate Incisions Cut Angle (expressed in degrees) Cut Angle - Expressed in degrees and represents the length of the arcuate incision Cut Angles cannot overlap
77 Programming Arcuate Incisions Side Cut Angle - The angle between the incision and the applanated corneal surface Range is 30 to 150 degrees Red 90 degrees Blue 30 degrees Yellow 150 degrees
78 ARCUATE KERATOTOMY (Astigmatism Correction)
79 Arcuate Incision Video
80 Femto Cataract Surgery Arcuate incision Clear Corneal Incisions/Parascentesis Capsulotomy Lens fragmentation
81 Too Early to SMILE Journal of Refractive Surgery-2017;33(5): Author-Khalifa, Comparing LASIK to SMILE at 6 months UCVA 20/20- LASIK-90.2%, SMILE- 78% Spherical equivalent within 0.5D LASIK 98%, SMILE-81.5% Cylinder < or equal to 0.5D LASIK- 100%, SMILE- 84.7%
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