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2009 ESCRS Meeting

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. Clinical trial on Invent ZO

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2009 ESCRS Meeting

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  1. 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

  2. Clinical trial on Invent ZO “EFFICACY AND TOLERANCE OF A NEW ASPHERIC INTRAOCULAR LENS” 12 month follow-up results Methodology: Clinical Data on ZO IOLs • Open multicenter trial: 3 European investigational sites • Centre 1: Dr Gatinel – France (coordinator) • Centre 2: Prof Dick – Germany • 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)

  3. Patients: Clinical trial on Invent ZO • 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 • Uncomplicated cataract surgery with intracapsular implantation of the IOL • Patient over 55 years-old • 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

  4. Patients (ctd): Clinical trial on Invent ZO • Main exclusion criteria: • Any ocular pathology except cataract • High myopia (<-6D), high hyperopia (>+4D) • High astigmatism (>1.5D) • Minimum pupil diameter of 4-5mm in mesopic conditions (after 2 minutes of adaptation to dark conditions)

  5. Objectives: Clinical trial on Invent ZO • 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), • Coma • Trefoil • Spherical aberrations Z(4,0) • Each evaluation is performed for the whole eye, for the cornea and for the internal eye structure • (crystalline lens or IOL)

  6. Clinical trial on Invent ZO Screened patients 65 Patients not satisfying all inclusion and non inclusion criteria 6 Included patients 59 Patients lost to follow-up or withdrawn for personal reason 4 Full analysis set 55 Female: 31 (56.4%) Male: 24 (43.6%) Age: 73.64+ 7.34 Range [56 ; 88] Patient disposition Demographic characteristics ( at inclusion)

  7. (presentation of the results obtained for the 55 patients from the Full Analysis Set) Patients at the inclusion visit: Control group Clinical trial on Invent ZO Sample size: 55 patients Far BCVA: 0.547 ± 0.396 logMAR Near BCVA: 0.398 ± 0.234 logMAR Sphere: 0.63 ± 1.98 D Cylinder: -0.58± 0.58 D Axis: 62.42 ± 51.87° Km: 44.10 ± 1.58 D Axial Length: 23.02 ± 0.91mm Target Refraction: -0.17 ± 0.58 D Sample size: 97 young healthy phakic eyes

  8. 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) The Invent ZO optic has been designed to provide the same amount of aberrations as the natural young crystalline lens Clinical trial on Invent ZO

  9. Clinical trial on Invent ZO Conclusion regarding MTF analysis: • Internal SA of patients implanted with the ZO IOL are notinferior 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 time • Difference between groups in Whole Eye HOA does not come from SA

  10. Clinical trial on Invent ZO Comparison of the Whole Eye and InternalSA Between Groups • CornealSAstable with age • InternalSA of patients implanted with the ZO IOL – at all intervalsand pupil diameter - are notinferior to internal SA of the control group -> the IOL reaches the intended performance

  11. Clinical trial on Invent ZO Assessment of Visual Acuity and Refraction • Stability of Visual acuity and refraction with time • Good predictability of refractive outcome

  12. Conclusions Corneal SAstable 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 performance Good outcomes in terms of visual acuity and predictability of refractive outcome Good tolerance in term of IOL stability, refraction, visual symptoms and PCO rate. Clinical trial on Invent ZO

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