F.I. Camesasca, MD Zeiss Invent ZO Aspheric IOL: Long-Term Results of Refractive and Aberrometric Analysis F. I. Camesasca* P. Vinciguerra D. Gatinel B. Dick 2009 ESCRS Meeting *The Author of this poster has received travel expense reimbursement from Zeiss

F.I. Camesasca, MD Clinical Data on ZO IOLs Clinical trial on Invent ZO “EFFICACY AND TOLERANCE OF A NEW ASPHERIC INTRAOCULAR LENS” 12 month follow-up results Methodology: Open multicenter trial: 3 European investigational sites Centre 1: Dr Gatinel – France (coordinator) Centre 1: Dr Gatinel – France (coordinator) Centre 2: Prof Dick – Germany Centre 2: Prof Dick – Germany Centre 3: Dr Vinciguerra/Dr Camesasca – Italy Centre 3: Dr Vinciguerra/Dr Camesasca – Italy Evaluation of the visual performances of the Invent ZO after Implantation using MTF analysis trial Comparison with a control group of phakic young eyes (ZO optic has been developed to provide the same spherical aberration rate then the one of a phakic eye)

F.I. Camesasca, MD Clinical trial on Invent ZO Patients: Scheduled sample size: 60 patients (20 patients per center – only one eye operated on and evaluated in the framework of the trial) Main inclusion criteria: Patient requiring routine cataract surgery Patient requiring routine cataract surgery Uncomplicated cataract surgery with intracapsular implantation of the IOL Uncomplicated cataract surgery with intracapsular implantation of the IOL Patient over 55 years-old Patient over 55 years-old Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent IOL power required comprised between 18 and 26 D IOL power required comprised between 18 and 26 D

F.I. Camesasca, MD Patients (ctd):Main exclusion criteria: Any ocular pathology except cataract High myopia ( +4D) High astigmatism (>1.5D) Minimum pupil diameter of 4- 5mm in mesopic conditions (after 2 minutes of adaptation to dark conditions) Clinical trial on Invent ZO

F.I. Camesasca, MD Objectives : Main objective: to evaluate the performance of the INVENT ZO in terms of visual performance, assessed by MTF measurements High order aberrations of order 3 to 5 (aberrations higher then 5 are considered as background noise),High order aberrations of order 3 to 5 (aberrations higher then 5 are considered as background noise), ComaComa TrefoilTrefoil Spherical aberrations Z(4,0)Spherical aberrations Z(4,0) Each evaluation is performed for the whole eye, for the cornea and for the internal eye structureEach evaluation is performed for the whole eye, for the cornea and for the internal eye structure (crystalline lens or IOL) Clinical trial on Invent ZO

F.I. Camesasca, MD Patient disposition Demographic characteristics ( at inclusion) Screened patients65 Patients not satisfying all inclusion and non inclusion criteria6 Included patients59 Patients lost to follow-up or withdrawn for personal reason4 Full analysis set55 Female: 31 (56.4%) Male: 24 (43.6%) Age: Range[56 ; 88] Clinical trial on Invent ZO

F.I. Camesasca, MD (presentation of the results obtained for the 55 patients from the Full Analysis Set) Patients at the inclusion visit: Control group Sample size: 55 patients Far BCVA: ± logMAR Near BCVA: ± logMAR Sphere: 0.63 ± 1.98 D Cylinder: -0.58± 0.58 D Axis: ± 51.87° Km: ± 1.58 D Axial Length: ± 0.91mm Target Refraction: ± 0.58 D Sample size: 97 young healthy phakic eyes Clinical trial on Invent ZO

F.I. Camesasca, MD Each aberration MTF has been compared to the control group, using a Non-inferiority testing as: A clinically relevant difference between 2 groups is not known for the MTF (as for example a difference of 0.15logMAR is considered as clinically significant)A clinically relevant difference between 2 groups is not known for the MTF (as for example a difference of 0.15logMAR is considered as clinically significant) The Invent ZO optic has been designed to provide the same amount of aberrations as the natural young crystalline lensThe Invent ZO optic has been designed to provide the same amount of aberrations as the natural young crystalline lens Clinical trial on Invent ZO

F.I. Camesasca, MD Conclusion regarding MTF analysis: Internal SA of patients implanted with the ZO IOL are not inferior to internal SA of the control group => the IOL reach the intended performanceInternal SA of patients implanted with the ZO IOL are not inferior to internal SA of the control group => the IOL reach the intended performance Internal SA of patients implanted with the ZO IOL are stable with timeInternal SA of patients implanted with the ZO IOL are stable with time Difference between groups in Whole Eye HOA does not come from SADifference between groups in Whole Eye HOA does not come from SA Clinical trial on Invent ZO

F.I. Camesasca, MD Comparison of the Whole Eye and Internal SA Between Groups Corneal SA stable with ageCorneal SA stable with age Internal SA of patients implanted with the ZO IOL – at all intervals and pupil diameter - are not inferior to internal SA of the control group -> the IOL reaches the intended performanceInternal SA of patients implanted with the ZO IOL – at all intervals and pupil diameter - are not inferior to internal SA of the control group -> the IOL reaches the intended performance Clinical trial on Invent ZO

F.I. Camesasca, MD Assessment of Visual Acuity and Refraction Stability of Visual acuity and refraction with timeStability of Visual acuity and refraction with time Good predictability of refractive outcomeGood predictability of refractive outcome Clinical trial on Invent ZO

F.I. Camesasca, MD Conclusions Corneal SA stable with age (already published)Corneal SA stable with age (already published) Internal SA of patients implanted with the ZO IOL are not inferior to internal SA of the control group => the IOL reach the intended performanceInternal SA of patients implanted with the ZO IOL are not inferior to internal SA of the control group => the IOL reach the intended performance Good outcomes in terms of visual acuity and predictability of refractive outcomeGood outcomes in terms of visual acuity and predictability of refractive outcome Good tolerance in term of IOL stability, refraction, visual symptoms and PCO rate.Good tolerance in term of IOL stability, refraction, visual symptoms and PCO rate. Clinical trial on Invent ZO