Single Center Post-Market Clinical Follow-Up (PMCF) Investigation for Assessing the Visual Performance of Hanita Lenses Intensity SL IOL in Comparison to Alcon Panoptix IOL
The goal of this clinical trial is to compare the visual performance between Intensity SL IOL and Panoptix IOL in men and women diagnosed with cataract who require cataract surgery procedure that meet the inclusion criteria and provide written informed consent will be enrolled in the study. The main questions it aims to answer are: 1. To show non-inferiority in binocular distance corrected visual acuity for far, intermediate and near distances after Trifocal IOL implantation. 2. To show non-inferiority in the Defocus Curve measurement 3. To show non-inferiority in Contrast Sensitivity measurement 4. To show non-inferiority in patient satisfaction Participants will attend a total of 10 study visits: 1 preoperative visit, 2 operations and 7 postoperative visits.
• Capability to understand and sign an IRB approved informed consent form and privacy authorization
• Age over 18 on the screening day
• Patients with bilateral age-related cataracts and planned bilateral cataract phacoemulsification combined Intraocular Lens implantation;
• Calculated IOL power is within range 15-30 Diopter (approximate range of axial lengths: 21-25.5mm)
• Normal corneas with corneal astigmatism below following value, measured by Biometer
‣ 1 D if with-the-rule (steep axis is vertical, between 60-120⁰)
⁃ 0.4 D if against-the-rule (steep axis is horizontal, 0-30⁰ or 150-180⁰)
⁃ 0.7 D if oblique (not one of the cases above)
• Post-operative best corrected distance visual acuity expected to be 0.3 logMAR or lower
• Patient motivated for trifocal IOL after screening by surgeon, willing and able to conform 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:
‣ Availability for the follow-up visits - 1 day, 1 week and 1 month after the first surgery
⁃ Availability for the second surgery - one week to two months after the first surgery
⁃ Availability for the follow-up visits - 1 day, 1 week, 1 month and 3 months after the second surgery