Investigation for Assessing the Visual Performance of Hanita Lenses Intensity SL IOL in Comparison to Alcon Panoptix IOL
Cataract
About this trial
This is an interventional treatment trial for Cataract focused on measuring IOL, Cataract, Hanita Lenses, Alcon, Intensity SL, Panoptix, Intra Ocular Lens
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Difficulty for cooperation (distance from their home, general health conditions) Previous ocular/corneal surgery that may affect refraction accuracy or visual acuity. 18 Protocol ID.: ISL-01 Version:2 Date: 20 Mar 2023 Capsule or zonular abnormalities that may affect postoperative centration or tilt of the 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 in general and macular pathologies in particular, diabetic retinopathy, uveitis, aniridia or iris atrophy, vitreous pathologies (patients with vitreous separation or floaters 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 or contraindicate implantation of the trifocal lens. Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that 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 participated in an ophthalmology clinical trial within the last 30 days. Traumatic cataract
Sites / Locations
- Universitäts-Augenklinik Heidelberg International Vision Correction Research Centre (IVCRC)Recruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Intensity SL IOL
Panoptix IOL
29 patients will be implanted bilaterally with Intensity SL IOL
29 patients will be implanted bilaterally with PanOptix IOL