Dr. Magda Rau Eye Clinic Cham, Germany

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3 and 6 Months clinical Results after Implantation of OptiVis Diffractive-refractive Multifocal IOL Dr. Magda Rau Eye Clinic Cham, Germany

Refractive zone of Progressive power for Far to Intermediate foci within 1.5 mm diameter Apodized Diffractive zone for Far and Near foci within 1.5-3.8 mm diameters Bi-sign Aspheric base surface of diffractive zone and lens perifery to improve contrast at distance for large pupils for different corneal shapes and with lens tilt and decentration Multifocal posterior surface design with 2.8 D Effective Add

Optic material Optic body Haptic material and shape Lens diameter Central Optic Thickness: 16.0 25.0 D Incision size Recommended A-Constant Hydrophilic acrylic (26% water) - 6-mm diameter - biconvex - Spherical anterior surface - Bi-sign aspheric multifocal posterior surface - Single-piece IOL - 5 degree anterior angulation 11.0 mm 0.92 mm 1.34 mm < 2 mm 117.2 118.1- use with nomogram

Light split between Far, Intermediate, Near and light Loss. Light loss is light focused outside the vision range between Far and Near Apodization increases shift in percentage of light from Near to Far with pupil increase Central refractive zone and unique apodization design of diffractive zone results in small percent of light loss, below 4.2%. This reduces negative impact on contrast and halos by OptiVis

Follow-up 3 months,6 months Follow-up evaluations include Uncorrected (UCVA) Best corrected distance VA (BCDVA) Intermediate visual acuity Near visual acuity

Bilateral cataracts for which phacoemulsification and posterior IOL implantation has been planned for both eyes Strong desire to achieve spectacle independence Willingness to accept potential optical side effects and longer optical adaptation period after surgery Naturally dilated pupil size (in dim light) > 4.0 mm for both eyes Preoperative corneal astigmatism of 1.0 D or less Systemic or ocular disease, that may affect vision Diagnosed degenerative visual disorders History of ocular trauma or prior ocular surgery Amblyopia or strabismus Corneal abnormalities such as stromal, epithelial or endothelial dystrophies Intraocular inflammation or recurrent ocular inflammatory condition Pupil abnormalities Capsule or zonule abnormalities that may affect postoperative IOL centration or tilt

The FVA is a precision vision testing device that can be used for clinical testing or used for vision testing for research and clinical trials The FVA s precision illumination is continually controlled by a microprocessor for accuracy and repeatability of tests Capable of testing the following: Visual Acuity monocular and binocular at near, distant, and intermediate Contrast Sensitivity testing with F.A.C.T. (Functional Acuity Contrast Test) can be performed in both day and night resting conditions; both with and without glare and with a choice of two different glare levels (1 Lux and 28 Lux for night conditions)

Mean correction: -0,43-0,32

meanmmean correction:

Mean correction:

Mean correction: -0,43-0,32

OptiVis - Contrast Sensitivity 2.5 Monocular Contrast Sensitivity Testing (Functional Image Analyzer testing) Daytime Conditions (85 cd/m2) Age 60-69 Age 70-79 logmar Contrast Sensitivity 2 1.5 1 Control Age >60* Upper Range, Age >18 Lower Range, Age >18 0.5 0 1.5 3 6 12 18 Spatial Frequency (Cycles per Degree)

OptiVis - Contrast Sensitivity Monocular Contrast Sensitivity Testing (Functional Image Analyzer testing) Nighttime Conditions (3 cd/m2), No Glare 2 Age 60-69 logmar Contrast Sensitivity 1.5 1 0.5 Age 70-79 Upper Range, Age >18 Lower Range, Age >18 0 1.5 3 6 12 18 Spatial Frequency (Cycles per Degree)

OptiVis - Contrast Sensitivity Monocular Contrast Sensitivity Testing (Functional Image Analyzer testing) Nighttime Conditions (3 cd/m2), With Glare 2 Age 60-69 logmar Contrast Sensitivity 1.5 1 0.5 Age 70-79 Upper Range, Age >18 Lower Range, Age >18 0 1.5 3 6 12 18 Spatial Frequency (Cycles per Degree)

Optical/Visuals Symptoms Halos at 3 and 6 months 100.0% 77.8% 75.0% 55.6% 44.4% 3 Months 50.0% 22.2% 6 Months 25.0% 0.0% 0.0% 0.0% None Mild Moderate Severe

Optical/Visuals Symptoms Night Glare 3 and 6 Months 100.0% 77.8% 83.3% 75.0% 50.0% 3 Months 25.0% 22.2% 16.7% 0.0% 0.0% 6 Months 0.0% None Mild Moderate Severe

Patient Satisfaction Survey How often do you wear glasses? (3, 6 Months) 57.1% 60.0% 42.9% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% 0.0% Always Sometimes Never

Patient Satisfaction Survey Are you satisfied with your vision without glasses during the day? (3, 6 Months) 60.0% 57.1% 50.0% 42.9% 40.0% 30.0% 20.0% 10.0% 0.0% 0.0% 0.0% 0.0% Not at all A little Moderately Mostly Completely

Patient Satisfaction Survey Are you satisfied with your vision without glasses at night? (3, 6 Months) 60.0% 57.1% 50.0% 40.0% 28.6% 30.0% 20.0% 14.3% 10.0% 0.0% 0.0% 0.0% Not at all A little Moderately Mostly Completely

Patient Satisfaction Survey Are you satisfied with your vision without glasses at night?( 3,6months) at night? (3, 6 Months) Mean correction: -0,43-0,32

The OptiVis diffractive-refractive multifocal IOL (Aaren Scientific) provides very good results for distance, intermediate and near vision. The six months results shows improvement in distance visual acuity and slight decrease in near visual acuity. After 6 months the perception of glares and halo significantly decreases. The satisfaction with the vision without the glasses at night improves.