LENS EXCHANGE WITH IMPLANTATION OF A BITORIC INTRAOCULAR LENS IN EYES WITH SIGNIFICANT ASTIGMATISM AFTER PREVIOUS CORNEAL SURGERIES

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1 LENS EXCHANGE WITH IMPLANTATION OF A BITORIC INTRAOCULAR LENS IN EYES WITH SIGNIFICANT ASTIGMATISM AFTER PREVIOUS CORNEAL SURGERIES Dimitrii Dementiev, MD, Anna Shipunova, MD, PhD Irina Ivanchikova, MD, Vera Veshchikova Blue Eye Centro di Chirurgia Oculare, Milano, Italy, International Center for Ophthalmology Moscow, Russia Financial Interest

2 Purpose To evaluate refractive outcomes, rotational stability and safety after lens exchange for customized AT TORBI 709M (Carl Zeiss) IOL in eyes previously underwent PKP, RK and PRK

3 AT TORBI 709M (Carl Zeiss Meditec) DIOPTER RANGE: Sphere: to D, 0.5 D increments Cylinder: +1.0 to D, 0.5 D increments Bitoric, plate haptics, Hydrophilic Acrylic, one piece IOL Aspheric (Aberration-neutral) MICS: Implantable trough 1.5 mm incision 6.0 mm optical/ 11.0 mm total diameter A-Const In bag implantation Individual calculation & manufacturing (customized) High rotational stability after surgery Easy rotation during surgery

4 Materials & Methods 34 eyes of 33 patients Preexisting induced corneal astigmatism of -3.0 to D Post-RK ectasia 4 eyes Keratoconus 15 eyes Myopia 15 eyes PKP 19 eyes RK 7 eyes PRK 8 eyes

5 Materials & Methods Uncorrected distance visual acuity (UDVA) Best-corrected distance visual acuity (BDVA) Autorefractokeratometry (Tomey) Slit-lamp examination with photo registration (Takagi, Japan), Software (Adobe Photoshop) Optical biometry, keratometry AC measuraments, WW size (Carl Zeiss IOL Master V.5.4.1, Carl Zeiss Meditec) Pachymetry, AC depth & angle size (Visante OCT Carl Zeiss Meditec) Corneal topography (ATLAS Revision Carl Zeiss Meditec)

6 Blue eye / Exclusion of liability: Carl Zeiss Meditec AG (CZM) provides a service for medical practices to calculate the recommended IOL refractive power. Calculation of these power recommendations will be made on the basis of the data of the patient using a proprietary calculation algorithm. The results of IOL calculation performed by CZM should be regarded as non-binding recommendations specifically matched to the CZM IOL product line. Note that these recommendations cannot replace the professional expertise of the health care specialist. Despite careful processing of the data transmitted, postoperative refractive errors cannot be excluded, since (a) prediction of the postoperative IOL position is based on the population mean and may significantly deviate in individual cases, (b) postoperative IOL dislocation (e.g. due to capsular phimosis etc.) cannot be predicted, (c) errors in the transmission of the biometric data cannot be excluded, and (d) accuracy of the biometric raw data cannot be verified by CZM. CZM shall not be liable for any potential postoperative refractive errors in connection with the IOL power recommendations submitted. Materials & Methods Questionnaire: spectacle independence, visual disturbances, and satisfaction with vision (1 = completely unsatisfied; 10 = completely satisfied) The toric IOL was customized, calculated and ordered from manufacturers in all cases (Carl Zeiss) Guidance for STACY Alignment - IOL Implantation Axis 51 ( ) Right Eye - OD AT TORBI 709M(P) implantation axis Toric IOL Request Quotation Order Postop Refractive Target: sph Customer / Surgeon Patient *Name Dr. Dementiev, Dimitri *ID 2276_13 *Institute/Clinic *Age 51 ( ) Piazza Fontana 6 Name Davidov, Leonid Milano IOL Type AT TORBI 709M(P) *Address IT Request / Order to Distributor- / CZM AG Fax / Address *Tel./Fax Distributor / Acri.Tec demso.orderexport@meditec.zeiss.com Biometry / Input data preop (to be filled in by customer - * MANDATORY fields) Date: Surgery Date: right (OD) Surgery Date: left (OS) r [mm] P [D] *Axis [ ] r [mm] P [D] *Axis [ ] *K1 Refractive *K1 52, *K2 *K2 37,69 72 *n=1,332 *AL [mm] Visus sc *AL [mm] 24,20 *n=1,336 Visus sc *ACD [mm] Visus cc *ACD [mm] Visus cc *n=1,3375 Sphere Cylinder Axis Sphere Cylinder Axis *n=1,338 [D] [D] [ ] [D] [D] [ ] Eye Glasses Eye Glasses Refraction Refraction *Target Ref. *Target Ref. Topography attached (yes/no) Topography attached (yes/no) *Devices Surgery Incision site OD/OS ( ) Effect of surgery on K1, K2, (OD/OS) / Comments Post-Keratoplasty Calculation (to be filled in by *CZM AG) Date: ASAS right (OD) left (OS) Residual Refraction IOL Power Residual Refraction IOL Power Sph. Equ. Sphere Cylinder Sphere Cylinder Sph. Equ. Sphere Cylinder Cylinder Sphere [D] Nr. [D] [D] [D] [D] [D] Nr. [D] [D] [D] [D] 1 1 0,42 3,26-5,68 9,50 12, ,06 2,92-5,71 10,00 12, ,30 2,57-5,73 10,50 12,00 Axis [ ] 90 Axis [ ] Left Eye - OS AT TORBI 709M(P) 162 implantation axis Axis = IOL position in eye* Marks = plus-cylinder axis = min. / flat IOL-Meridian 0 Axis = IOL position in eye* Marks = plus-cylinder axis = min. / flat IOL-Meridian 0 *Correct graphical display of the implantation axis requires Microsoft Office XP or later versions. Calculated with: Postop estimated ACD: OD= / OS= 4,41 Corneal refractive index n' = 1,3375 Order (to be filled in by customer) IOL : right (OD) IOL : left (OS) Sphere Cylinder Delivery Sphere Cylinder Delivery No. [D] [D] Quantity date No. [D] [D] Quantity date STACY (reusable screen transparency) desired (yes/no) Order-No. (Customer) Date Sign Please send order to: Carl Zeiss Meditec AG, Göschwitzer Strasse 51-52, D Jena International Customer Service: Tel Fax demso.orderexport@meditec.zeiss.com IOL-Berechnung-V23-KW _ASAS.xls Dr.Dementiev_Davidov Version 23 / 01/2012 / RB Date of print:

7 MARKING 0 & 180 axis Patient Preparation Topic Anestesia (Lidocaine 2%) Under Slit lamp in sit position Just before the surgery to keep the marks visible

8 SURGICAL TECHNIQUE Topic anestesia 2% Lidocain 20 min prior surgery Midriasis (Fenelefrin,Tropicamid1%, Deltamidrin) Clear Cornea self sealing incision of 2.4 mm MICS of 1.5 Viscoelastic in AC Capsulorexis mm Facoimulsification I/A cortex removal Viscoelastic injection in capsular bag IOL implantation IOL positioning

9 SURGICAL TECHNIQUE IOL positioning according to steep corneal axis

10 Mean (SD) Preoperative data Median (Range) PKP group PRK group RK group LogMAR UDVA 1.05 (0.32) Manifest sphere (D) (2.57) Manifest cylinder (D) (1.92) Manifest SE (D) (2.86) LogMAR CDVA 0.42 (0.21) 0.93 (0.52) 1.20 (0.30) 1.00 (0.40 to 1.52) 1.30 (0.20 to 1.30) 1.00 (1.00 to 1.80) 0.53 (2.03) (3.65) (-8.25 to 1.50) 1.25 (-4.00 to 2.25) (-7.00 to 3.00) (1.36) (1.21) ( to -6.00) (-6.00 to -2.50) (-7.00 to -3.75) (2.37) (3.89) ( to -1.50) (-7.00 to 0.075) ( to 0.25) 0.35 (0.21) 0.49 (0.04) 0.50 (0.00 to 0.80) 0.50 (0.10 to 0.50) 0.50 (0.40 to 0.50) p-value <0.001 < Mean (SD) Postoperative data Median (Range) PKP group PRK group RK group LogMAR UDVA 0.29 (0.21) Manifest sphere (D) (1.70) Manifest cylinder (D) (1.60) Manifest SE (D) (2.05) LogMAR CDVA 0.07 (0.04) 0.12 (0.03) 0.20 (0.07) 0.30 (0.05 to 1.00) 0.10 (0.10 to 0.17) 0.17 (0.10 to 0.30) (0.42) (0.20) (-5.00 to 0.50) 0.00 (-1.00 to 0.50) (-0.50 to 0.00) (0.73) (0.17) (-6.00 to 0.00) (-2.00 to -0.25) (-1.00 to -0.50) (0.60) (0.20) (-7.50 to 0.00) (-2.00 to -0.13) (-1.00 to -0.50) 0.01 (0.00) 0.08 (0.03) 0.10 (0.00 to 0.10) 0.01 (0.01 to 0.01) 0.10 (0.05 to 0.10) p-value eyes of 33 patients Mean age: 41.5 ± 6,4 years (31-51) Mean postoperative follow-up 31.3± 8.1 months (22-55) The mean interval from previous surgery to toric IOL implantation 9.9 ±6.1 years (3-22)

11 Mean UCVA (LogMAR) Efficacy 1,2 1 0,8 0,6 0,4 PRK PKP RK 0,2 0 pre op 1 month 6 months 12 months 24 months 30 months

12 EFFICACY

13 SAFETY

14 PREDICTABILITY

15 Post RK Post PRK Scatter plot of polar astigmatic vectors Pre-operative corneal astigmatism Post-operative refractive cylindrical error

16 Scatter plot of polar astigmatic vectors Post PKP Pre-operative corneal astigmatism Post-operative refractive cylindrical error

17 Mean Manifest spherical equivalent (D) 2 1,5 Stability pre op 1 month 6 months 12 months 24 months 30 months RK PKP PRK 1 0,5 0-0,5-1 -1,5-2

18 ROTATIONAL STABILITY 2-86% 5-100%

19 PATIENT SATISFACTION 1. Spectacle independence 63, 7% 2. Visual disturbance (halo and glare) 21,4%, 3. Satisfaction with vision: - 92,3%

20 CONCLUSION Customized Refractive Lens Exchange for AT TORBI Toric IOL (Carl Zeiss) Effective Safe Predictable Stable solution for correction of high level of induced corneal astigmatism in eyes that underwent corneal transplantation and corneal refractive procedures

21 Dimitrii Dementiev, MD Milano, Italy Moscow, Russia THANK YOU