L. Spadea, R. Ferrante, F. Romani, A. Di Gregorio

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University of L Aquila Eye Clinic Head: Prof. Leopoldo Spadea ULTRAFAST EXCIMER LASER FOR TRANS-EPITHELIAL CUSTOMIZED PHOTOREFRACTIVE SURGERIES: CLINICAL RESULTS WITH 6 MONTHS FOLLOW UP L. Spadea, R. Ferrante, F. Romani, A. Di Gregorio ESCRS - Lisbon, 10 September 2005

TOPOGRAPHICALLY GUIDED GUIDED PHOTOREFRACTIVE KERATECTOMY (PRK) Advantages Better astigmatic correction Possibility of correcting irregular astigmatism Smaller ablation volume compared with standard treatments Better visual performance

Ligi Cusm Ablation Platform An integrated system of devices and software which is used cusmize refractive and therapeutic surgery specific each patient s Pupillometer Pupil Diameter Topographer Corneal Morphology Ablation Laser Treatment CIPTA Surgeon Subjective Refraction

Cusm Ablation Platform This process occurs in three phases: Acquisition Planning Execution

Acquisition Corneal Morphology Refractive Error Morphology + Error + Pupillary Dynamics Tomography unit Subjective Refraction or Refracmeter Dynamic Pupillometer

Pupillometry The pupillometer calculates the Ideal Pupil, used choose the useful optic zone minimizing the tissue ablation Ideal Pupil = pupil diameter during 95% of all circumstances typically encountered by patient during his/her life: Dark room Artificial light open space Night driving Artificial light close space Day light close space Day light open space

CIPTA ( Corneal Interactive Programmed Topographic Ablation) The treatment setup requires the following parameters: Center of the ablation Center of the laser reference system Axis of the ablation profile Phopic pupil Optimized pupil Outer transition diameter Refractive correction Asphericity Procedure type Thickness and width of aumatic debridement (optional)

ires The Ultrafast Excimer Laser Frequency = 1000 Hz Gaussian flying spot = 650 μm Constant delivery frequency per area Setup / Calibration = tally aumated

Purposes of the study Evaluation of efficacy, predictability, safety and stability of pographically- guided transepithelial PRK using CIPTA software program with ires ultrafast excimer laser

Patients and Methods 29 eyes (13 RE, 16 LE) 21 patients (14 F, 7 M) Age: 31.9 ys ± 5.74 SD (range, 25-52) 52) Minimum Follow-up: 6 months

Preoperative ophthalmic examination Slit-lamp lamp biomicroscopy Tonometry Anterior and posterior corneal pography, 3-D D pachymetry Dynamic pupillometry Uncorrected visual acuity (UCVA) Best spectacle-corrected corrected visual acuity (BCVA) measured (cycloplegia( cycloplegia) Specular endothelial microscopy

Preoperative data UCVA BCVA SE (D) Central Corneal Thickness (μm) Endothelial Cell density (Cell / mm 2 ) Mean ± SD (range) ± 20/125 (20/600 20/30) 20/20 (20/20) -3.64D ± 1.45 (-8.25-2) 558.83 ± 32.04 (502 636) 2188.45 ± 67.22 (2074 2341)

Preoperative data Mean ± SD (range) Pupil (mm) 5.94 ± 0.56 (5 7) Optic zone (mm) 6.24 ± 0.59 (5 7.1) Transition zone (mm) 7.66 ± 0.62 (6.25 9.15)

UCVA UCVA Preop Preop 2 weeks weeks 1 month month 3 months months 6 months months Mean Mean ± SD SD (range) (range) 0 0 ± 20/125 20/125 (20/600 (20/600 20/30) 20/30) ± 20/10 20/10 (20/60 (20/60 20/20) 20/20) ± 20/12 20/12 (20/30 (20/30 20/20) 20/20) ± 20/150 20/150 (20/30 (20/30 20/20) 20/20) ± 20/125 20/125 ( ( 20/20) 20/20) RESULTS RESULTS

Preop Preop 2 weeks weeks 1 month month 3 months months 6 months months Mean Mean ± SD SD (range) (range) 20/20 20/20 (20/20) (20/20) ± 20/10 20/10 (20/60 (20/60 20/20) 20/20) ± 20/10 20/10 (20/60 (20/60 20/20) 20/20) ± 20/150 20/150 (20/30 (20/30 20/20) 20/20) 20/20 20/20 (20/20) (20/20) BCVA BCVA RESULTS RESULTS

RESULTS 100 90 80 100 79 Preop BSCVA and Posp UCVA 83 Preop 1 Month 6 Month 70 60 50 40 30 20 10 11 11 6 11 0 20 25 30 Vision (Snellen 20/ notation) After 6 months f-up f 83% of the eyes had an UCVA of 20/20

RESULTS Sphere Equivalent Preop (D) 2 weeks (D) 1 month (D) 3 months (D) 6 months (D) Mean ± SD (range) -3.17 ± 1.45 (-8.25-2) 0.72 ± 0.24 (+0.75 +1.25) 0.32 ± 0.23 (+0.25 +0.75) 0.13 ± 0.25 (-0.50 +0.75) 0.10 ± 0.28 (-0.75 +0.75)

RESULTS 2,00 Mean Refractive Outcome over Time Spheroequivalent +/- 1 Standard Deviation Preop 2 Weeks 1 Month 3 Month 6 Month 1,00 0,72 0,00 0,32 0,13 0,10 Spherical equivalent (D) -1,00-2,00-3,00-3,17-4,00-5,00

RESULTS Pre-op CCT (μm) Estimated Maximum Ablation Depth (µm) 6 months post-op op CCT (μm) Mean ± SD (range) 558.83 ± 32.04 (502 636) 79.044 ± 30.56 (38 136) 500.68 ± 43.74 (421 561) 25% less

RESULTS Endothelial Cell density (Cell / mm 2 ) Endothelial Cell density (Cell / mm 2 ) Mean ± SD (range) 2188.45 ± 67.22 (2074 2341) 2088.56 ± 71.34 (2017 2159) p>0.005

Contrast Sensitivity CSV-1000 Contrast Sensitivity test 4 contrast levels (1.5-18 cycles/degree) BSCVA 6 months post-op op

Phopic Contrast Sensitivity Sensitivity (log units) 9 8 7 6 5 4 3 2 1 0 1,5 3 6* 12 18 Pre-op. Post-op. op. Cycles / Degree (* P<0.05) Sensitivity (log units) 10 8 6 4 2 0 Mesopic Contrast Sensitivity 1,5 3* 6* 12 18 Cycles / Degree (* P < 0.05)

P.L., F, 36 ys Pre-op -2.50sph = -1.50cyl (180 ) 20/20 Post-op PLANO 20/20

P.L., F, 36 ys Post-Op: Plano 20/20 Pre-Op: Op:-2.50sph= 2.50sph=-0.50cyl 0.50cyl (180 ) ) 20/20

P.L., F, 36 ys Pre-op -2.50sph = -1.50cyl (180 ) 20/20 Post-op PLANO 20/20

T.S., F, 32 ys Pre-op -3.75sph 20/20 Post-op op PLANO 20/20

T.S., F, 32 ys Post-Op: Plano 20/20 Pre-Op: -3.75sph 20/20

CONCLUSIONS The correction of refractive errors (also with irregular astigmatism) using transepithelially the pographically-guided guided ires ultra-fast excimer laser may be considered safe and effective with stable visual outcome