Investigation for Assessing the Visual Performance of Hanita Lenses Intensity SL IOL in Comparison to Alcon Panoptix IOL

Inclusion Criteria:

• Capability to understand and sign an IRB approved informed consent form and privacyauthorization

• Age over 18 on the screening day

• Patients with bilateral age-related cataracts and planned bilateral cataractphacoemulsification combined Intraocular Lens implantation;

• Calculated IOL power is within range 15-30 Diopter (approximate range of axiallengths: 21-25.5mm)

• Normal corneas with corneal astigmatism below following value, measured by Biometer

1. 1 D if with-the-rule (steep axis is vertical, between 60-120⁰)

2. 0.4 D if against-the-rule (steep axis is horizontal, 0-30⁰ or 150-180⁰)

3. 0.7 D if oblique (not one of the cases above)

• Post-operative best corrected distance visual acuity expected to be 0.3 logMAR orlower

• Patient motivated for trifocal IOL after screening by surgeon, willing and able toconform to the study requirements

• Fundus visualization is possible

• Absence of retinal or optic nerve diseases

• Clear intraocular media other than cataract

• When scheduling the first surgery, the patient shall commit to:

1. Availability for the follow-up visits - 1 day, 1 week and 1 month after thefirst surgery

2. Availability for the second surgery - one week to two months after the firstsurgery

3. Availability for the follow-up visits - 1 day, 1 week, 1 month and 3 monthsafter the second surgery

Exclusion Criteria:

• Difficulty for cooperation (distance from their home, general health conditions)

• Previous ocular/corneal surgery that may affect refraction accuracy or visualacuity.

18 Protocol ID.: ISL-01 Version:2 Date: 20 Mar 2023

• Capsule or zonular abnormalities that may affect postoperative centration or tilt ofthe lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)

• History or evidence of any ocular disease that may affect visual acuity (i.e.uncontrolled glaucoma, ocular injury, corneal pathologies, retinal pathologies ingeneral and macular pathologies in particular, diabetic retinopathy, uveitis,aniridia or iris atrophy, vitreous pathologies (patients with vitreous separation orfloaters can be included).

• Rubella cataract.

• Amblyopia

• Use of systemic or ocular medication that might affect vision

• Patients with, strabismus, former fruste keratoconus or keratoconus

• Usage of contact lenses during participation

• Any other ocular condition that may predispose a subject to future complications orcontraindicate implantation of the trifocal lens.

• Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupilsthat do not dilate at least 3.5 mm under mesopic/scotopic conditions)

• Pregnant, lactating, or planning to become pregnant during the course of the trial.

• Allergy or intolerance to required study medications (including antibiotic).

• Subjects participating in a concurrent clinical trial or if they have participatedin an ophthalmology clinical trial within the last 30 days.

• Traumatic cataract