fabrizio@camesasca.comfabrizio@camesasca.com F.I. Camesasca, MDF.I. Camesasca, MD

Zeiss Invent ZO Aspheric Zeiss Invent ZO Aspheric IOL: Long-Term Results of IOL: Long-Term Results of Refractive and Aberrometric Refractive and Aberrometric

AnalysisAnalysis

F. I. Camesasca*F. I. Camesasca*

P. VinciguerraP. Vinciguerra

D. GatinelD. Gatinel

B. DickB. Dick

2009 ESCRS Meeting

*The Author of this poster has received travel expense reimbursement from Zeiss*The Author of this poster has received travel expense reimbursement from Zeiss

fabrizio@camesasca.comfabrizio@camesasca.com F.I. Camesasca, MDF.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 Open multicentermulticenter trial: 3 European investigational sites trial: 3 European investigational sitesCentre 1: Dr Gatinel – France (coordinator)Centre 1: Dr Gatinel – France (coordinator)Centre 2: Prof Dick – GermanyCentre 2: Prof Dick – GermanyCentre 3: Dr Vinciguerra/Dr Camesasca – ItalyCentre 3: Dr Vinciguerra/Dr Camesasca – Italy

Evaluation of the visual performances of the Invent ZO after Evaluation of the visual performances of the Invent ZO after Implantation using Implantation using MTF analysisMTF analysis

trialtrial

ComparisonComparison with a control group of phakic young eyes (ZO with a control group of phakic young eyes (ZO optic has been developed to provide the same spherical optic has been developed to provide the same spherical aberration rate then the one of a phakic eye)aberration rate then the one of a phakic eye)

fabrizio@camesasca.comfabrizio@camesasca.com F.I. Camesasca, MDF.I. Camesasca, MD

Clinical trial on Invent ZOClinical trial on Invent ZO

Patients: Scheduled sample size: 60 patients (20 patients Scheduled sample size: 60 patients (20 patients per center – only per center – only oneone eye operated on and eye operated on and evaluated in the framework of the trial)evaluated in the framework of the trial)

Main inclusion criteria:Main inclusion criteria:Patient requiring routine cataract surgeryPatient requiring routine cataract surgeryUncomplicated cataract surgery with Uncomplicated cataract surgery with intracapsular implantation of the IOLintracapsular implantation of the IOLPatient over 55 years-oldPatient over 55 years-oldPatient informed of the consequences and Patient informed of the consequences and constraints of the protocol and who has given constraints of the protocol and who has given his/her written informed consenthis/her written informed consentIOL powerIOL power required comprised between required comprised between 18 18 and 26 Dand 26 D

fabrizio@camesasca.comfabrizio@camesasca.com F.I. Camesasca, MDF.I. Camesasca, MD

Patients (ctd): Main exclusion criteria:Any ocular pathology except cataractHigh 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)

Clinical trial on Invent ZOClinical trial on Invent ZO

fabrizio@camesasca.comfabrizio@camesasca.com F.I. Camesasca, MDF.I. Camesasca, MD

Objectives: Main objectiveMain objective: :

to evaluate the to evaluate the performanceperformance of the INVENT ZO of the INVENT ZO in terms of visual performance, assessed by MTF in terms of visual performance, assessed by MTF measurements measurements

•High order aberrationsHigh order aberrations of order 3 to 5 of order 3 to 5 (aberrations higher then 5 are considered as (aberrations higher then 5 are considered as background noise), background noise),

•Coma Coma

•TrefoilTrefoil

•Spherical aberrations Z(4,0)Spherical aberrations Z(4,0)

•Each evaluation is performed for the Each evaluation is performed for the whole eyewhole eye, , for the for the corneacornea and for the and for the internal eyeinternal eye structure structure

(crystalline lens or IOL)(crystalline lens or IOL)

Clinical trial on Invent ZOClinical trial on Invent ZO

fabrizio@camesasca.comfabrizio@camesasca.com F.I. Camesasca, MDF.I. Camesasca, MD

Patient disposition

Demographic

characteristics

( at inclusion)

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]

Clinical trial on Invent ZOClinical trial on Invent ZO

fabrizio@camesasca.comfabrizio@camesasca.com F.I. Camesasca, MDF.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 patientsSample size: 55 patients

Far BCVA: 0.547 ± 0.396 logMARFar BCVA: 0.547 ± 0.396 logMAR

Near BCVA: 0.398 ± 0.234 logMARNear BCVA: 0.398 ± 0.234 logMAR

Sphere: 0.63 ± 1.98 DSphere: 0.63 ± 1.98 D

Cylinder: -0.58± 0.58 DCylinder: -0.58± 0.58 D

Axis: 62.42 ± 51.87°Axis: 62.42 ± 51.87°

Km: 44.10 ± 1.58 DKm: 44.10 ± 1.58 D

Axial Length: 23.02 ± 0.91mmAxial Length: 23.02 ± 0.91mm

Target Refraction: -0.17 ± 0.58 DTarget Refraction: -0.17 ± 0.58 D

Sample size: 97 young healthy phakic eyesSample size: 97 young healthy phakic eyes

Clinical trial on Invent ZOClinical trial on Invent ZO

fabrizio@camesasca.comfabrizio@camesasca.com F.I. Camesasca, MDF.I. Camesasca, MD

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

Clinical trial on Invent ZOClinical trial on Invent ZO

fabrizio@camesasca.comfabrizio@camesasca.com F.I. Camesasca, MDF.I. Camesasca, MD

Conclusion regarding MTF analysis:Conclusion regarding MTF analysis:

•Internal SAInternal SA of patients implanted with the of patients implanted with the ZOZO IOL are IOL are notnot inferiorinferior to internal SA of the control group => the to internal SA of the control group => the IOL IOL reach the intended performance reach the intended performance

•Internal SAInternal SA of patients implanted with the ZO IOL are of patients implanted with the ZO IOL are stable with timestable with time

•Difference between groups in Whole Eye HOA does Difference between groups in Whole Eye HOA does notnot come from SAcome from SA

Clinical trial on Invent ZOClinical trial on Invent ZO

fabrizio@camesasca.comfabrizio@camesasca.com F.I. Camesasca, MDF.I. Camesasca, MD

Comparison of the Comparison of the Whole EyeWhole Eye and and InternalInternal SASA Between Groups Between Groups

4.5 mm pupil diameter Reference N=97

INVENTZO (M1) N=55

INVENTZO (M6) N=55

INVENTZO (M12) N=55

SA whole eye (µm) -0.0035 +/- 0.0493 -0.0124 +/- 0.0513 -0.0133 +/- 0.0692 -0.0277 +/- 0.0694 SA cornea (µm) 0.0910 +/- 0.0475 0.0843 +/- 0.0558 0.0818 +/- 0.0453 0.0856 +/- 0.0385 SA internal (µm) -0.0946 +/- 0.0416 -0.0974 +/- 0.0482 -0.0951 +/- 0.0597 -0.1133 +/- 0.0541

3 mm pupil diameter Reference N=97

INVENTZO (M1) N=55

INVENTZO (M6) N=55

INVENTZO (M12) N=55

SA whole eye (µm) -0.0042 +/- 0.0102 -0.0045 +/- 0.0129 -0.0081 +/- 0.0174 -0.0081 +/- 0.0158 SA cornea (µm) 0.0157 +/- 0.0184 0.0169 +/- 0.0202 0.0131 +/- 0.0188 0.0158 +/- 0.0126 SA internal (µm) -0.0199 +/- 0.0196 -0.0215 +/- 0.0192 -0.0199 +/- 0.0180 -0.0239 +/- 0.0192

•CornealCorneal SASA stablestable with with ageage •InternalInternal SASA of patients implanted with the ZO IOL – of patients implanted with the ZO IOL – at all intervalsat all intervals and pupil diameterand pupil diameter - are - are notnot inferiorinferior to internal SA of the control to internal SA of the control group -> the group -> the IOL IOL reaches the intended performance reaches the intended performance

Clinical trial on Invent ZOClinical trial on Invent ZO

fabrizio@camesasca.comfabrizio@camesasca.com F.I. Camesasca, MDF.I. Camesasca, MD

Assessment of Visual Acuity and RefractionAssessment of Visual Acuity and Refraction

M1 (N=55) M6 (N=55) M12 (N=55) Best corrected Distance vision (LogMar) 0.058 +/- 0.138 0.043 +/- 0.084 0.086 +/- 0.096 Best corrected Near vision (LogMar) 0.097 +/- 0.149 0.085 +/- 0.091 0.096 +/- 0.083 Refraction subjective sphere (dioptres) -0.28 +/- 0.82 -0.22 +/- 0.89 -0.08 +/- 0.95 Refraction subjective cylinder (dioptres) -0.77 +/- 0.53 -0.60 +/- 0.47 -0.70 +/- 0.48 Diff. effective vs target refraction (SE) (D)

-0.48 +/- 0.91 -0.22 +/- 0.79 -0.12 +/- 0.85

Absolute value of the diff. effective vs target refraction (SE) (D)

0.78 +/- 0.67 0.60 +/- 0.55 0.67 +/- 0.53

•Stability of Visual acuity and refraction with Stability of Visual acuity and refraction with timetime •Good predictability of refractive outcomeGood predictability of refractive outcome

Clinical trial on Invent ZOClinical trial on Invent ZO

fabrizio@camesasca.comfabrizio@camesasca.com F.I. Camesasca, MDF.I. Camesasca, MD

ConclusionsConclusions

•Corneal SACorneal SA stablestable with age (already published) with age (already published)•Internal SAInternal SA of patients implanted with the of patients implanted with the ZOZO IOL IOL are are not inferiornot inferior to internal SA of the control group to internal SA of the control group => the IOL reach the intended performance => the IOL reach the intended performance •Good outcomesGood outcomes in terms of in terms of visual acuityvisual acuity and and predictabilitypredictability of refractive outcome of refractive outcome•Good Good tolerancetolerance in term of IOL in term of IOL stabilitystability, , refractionrefraction, , visual visual symptomssymptoms and and PCOPCO rate rate..

Clinical trial on Invent ZOClinical trial on Invent ZO