Outcomes after WIOL CF accommodative intraocular lens implantation

Outcomes after WIOL – CF accommodative intraocular lens implantation Ioannis G. Pallikaris MD, Ph. D, Dimitra M. Portaliou MD, Sophia I. Panagopoulou Ph. D Institute of Vision and Optics University of Crete School of Medicine Heraklion, Crete Greece

Financial Disclosure None of the authors has financial interests or relationships to disclose

WIOL – CF: Polyfocal hyperbolic optics Refractive power is maximum in the centre and gradually decreases in the periphery

WIOL – CF Features and benefits Continuous sharp edge Smooth gradual transition between central and peripheral optics Aspheric hyperboloid optics Full disc configuration Less optical complications, optimum vision quality

WIOL- CF change of focus via lens deformation due to the action of natural focusing apparatus (cilliary muscle and zonules): F 1 F 2

Clinical experience so far 11 key scientific publications and presentations Results for 476 WIOL-CF eyes recorded in clinical trials adding to more than 500 eye-years of clinical-trial reported experience Predominantly investigator driven studies and publications

WIOL-CF consistently shows accommodation range of more than 2 D, that corresponds to the accomodation range of natural crystalline lens in 42 -50 years of age. The range is stable over the long-term (up to 9 years) Study / Observation Number of Eyes Accommodation Range Time of Evaluation Pasta J 2003 79 2 D 3 years (67 eyes, 9 years follow-up) Pasta J et al 2006 26 2. 2 D (young active: 2 -3 D) over 12 m Nylander A et al 2006 51 ˃ 2. 25 D Up to 24 months Pallikaris IG 2011 50 2 D 24 months

Materials and Methods 25 patients (50 eyes) Mean age: 65, 3 ± 8, 4 years (range from 53 to 83 years) 12 male, 13 female All patients underwent routine cataract surgery and WIOL – CF accommodative intraocular lens implantation.

Exclusion Criteria Astigmatism higher than 1. 25 diopters Pre-existing ocular history corneal endothelial disease, abnormal cornea, macular degeneration, retinal degeneration, glaucoma, and chronic drug miosis. Previous refractive surgery Retinal conditions or predisposition to retinal conditions, previous history of/or predisposition to: retinal detachment or proliferative diabetic retinopathy. Amblyopia Clinically severe corneal dystrophy (e. g. , Fuchs') Extremely shallow anterior chamber Recurrent anterior or posterior segment inflammation of unknown etiology, or any disease producing an inflammatory reaction in the eye (e. g. iritis or uveitis). Aniridia Optic nerve atrophy Trauma

Implantation

PREOP Log. MAR CDVA Mean±SD [Range] Log. MARUDVA Mean±SD [Range] 0. 25 ± 0. 16 0. 84± 0. 62 [0. 0 to 0. 8] [CF to 0. 24] Last Postoperative Days/ Months Mean±SD [Range] 649. 32± 378. 18 [1404 to 98] 21. 64± 12. 61 [46. 8 to 3. 27] Last POSTOP Log. MARCDVA Mean±SD [Range] Log. MAR UDVA Mean±SD [Range] 0. 08± 0. 07 0. 16± 0. 13 [0. 0 to 0. 22] [0. 0 to 0. 54]

Safety No eye has lost lines of CDVA 88% of patients gained ≥ 1 lines of CDVA

Stability 1. 30 1. 20 1. 10 1. 00 Visual Accuity (Log. Mar) 0. 90 0. 83 0. 70 0. 60 CDVA 0. 50 UDVA 0. 40 0. 30 0. 25 0. 20 0. 18 0. 11 0. 00 0. 17 0. 14 0. 18 0. 16 0. 10 0. 09 0. 08 -0. 10 Pre. Op 1 month 3 months 6 months 12 months Time After Surgery 0. 00 Log. Mar equals at 1. 00 decimal Visual Acuity Last Post. Op

Uncorrected Near Visual Acuity 72% of our patients had J 2 or better, at the last follow – up examination, measured with Birkhauser reading charts at a distance of 33 cm under photopic conditions.

Uncorrected Intermediate Visual Acuity 72% of our patients had J 2 or better, at the last follow – up examination, measured with Birkhauser reading charts at a distance of 66 cm under photopic conditions.

Natural Accommodation D I F. M A P N E A R F A R

Pseudoaccommodation assessed with the i. Trace NEAR Range 9. 35 D Max -3. 53 D FAR Max diff -7. 20 D Mean diff. -1. 18 D

Pseudoaccommodation assessed with the i. Trace NEAR Range 6. 55 D Max -4. 84 D Max diff -3. 66 D Mean diff. -1. 00 D FAR

Slit Lamp photos of patients

AS – OCT image (Visante)

Conclusions WIOL – CF can be considered a very promising alternative solution for patients that lead an active life and require good vision near, intermediate and far. In our patient series all patients obtained some level of accommodation which remained stable throughout the follow – up period. No complications occurred intra or postoperatively Larger series of patients and longer follow-up is necessary in order to confirm the encouraging results