Clinical Evaluation Study for Assessing the Visual Performance of Hanita Lenses Trifocal IOL

Study Overview
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Brief Summary
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Hanita Lenses Trifocal IOL, SeeLens AFR (Intensity IOL).Prospective, single-arm single-center, open-label study.

Detailed Description
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Device: Hanita Lenses Trifocal IOL, SeeLens AFR (Intensity IOL). Indication studied: The Hanita Lenses Trifocal IOL is intended for implantation in the capsular bag in the posterior chamber in order to replace the crystalline lens of the eye to attain visual correction of aphakia in adult patients in whom a cataractous lens has been removed, who desire improved uncorrected vision, useful near and intermediate visual functions, and reduced spectacle dependence. Study description: This study is a prospective, single-arm single-center, open-label study.

Official Title
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Clinical Study for Assessing the Visual Performance of Hanita Lenses New Trifocal Intraocular Lens

Conditions
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Cataract

Intervention / Treatment
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* Device: cataract surgery and intraocular lens implantation - both eyes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 45 years and under 75 years. Patients with bilateral age-related cataracts, require bilateral cataract phacoemulsification combined Intraocular Lens implantation; Patients with an axial length of 22-24.5mm. Normal corneas with less than 0.75D of regular corneal astigmatism. Post-operative best-corrected visual acuity projected to be 0.3 logMAR or lower. Patient motivated for trifocal IOL after screening by the surgeon. Fundus visualization is possible. Absence of retinal or optic nerve diseases Signed informed consent Exclusion Criteria: Previous ocular/corneal surgery that may affect refraction accuracy or visual acuity. 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 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) Patients with pupil diameter greater than 4mm in photopic 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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm<br>single arm open label study | Device: cataract surgery and intraocular lens implantation - both eyes<br>* cataract surgery and intraocular lens implantation for both eyes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular visual acuity for far, intermediate and near distance after Trifocal IOL implantation | Binocular visual acuity for far, intermediate and near distance after Trifocal IOL implantation | 90-110 days post op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defocus Curve | Will be obtained using an ETDRS chart or PV numbers. Patient's pupil diameter will be evaluated. In the statistical stage patients will be categorized according to smaller than 2.5mm, between 2.5 and 4.5mm and above 4.5mm for mesopic and photopic conditions. The test will be performed using a phoropter to create defocus in 0.5D increments, starting from 1D to -4D relative to emmetropia so that the patient will be corrected for far vision. | 90-110 days post op | 
| Contrast Sensitivity | Will be evaluated using a sine wave gratings chart (FACT) at mesopic and photopic conditions. Measurements will be performed with optimal refractive correction. Luminance for photopic conditions will be 85cd/m² and 5cd/m² for mesopic conditions. Small deviations are allowed. The working interval for photopic conditions is 75-95cd/m² and for mesopic conditions is 5-15cd/m². Luminance for photopic and mesopic conditions will be monitored using Illuminance meter and documented. Results will be expressed as values. | 90-110 days post op | 
| patient satisfaction | Subjective evaluation will be performed using the modified VF-14 questionnaire for quality of life, in addition to satisfaction questionnaire. | 90-110 days post op |