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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:
Participants will attend a total of 10 study visits: 1 preoperative visit, 2 operations and 7 postoperative visits.
Full description
This study is a single center, prospective, (1:1) randomized, unblinded, controlled study carried out in Germany according to Art. 74 MDR (PMCF study) or according to Art. 82 MDR / § 47 Para. 3 MPDG is carried out.
The lead investigator at the Heidelberg University Eye Clinic is Prof. Dr. Gerd U. Auffarth.
This study examines the visual performance of the trifocal Hanita Lenses Intensity SL IOL (study lens) compared to the trifocal Alcon PanOptix IOL (comparison lens) in bilaterally implanted patients. Clinical investigations including patient-reported results from the test group will be compared with those from the control group.
A total of approximately 58 patients will be included at 1 clinical center. Subjects participating in the study will attend a maximum of 10 study visits (1 preoperative, 2 operative and up to 7 postoperative) over a period of 3-7 months.
Only patients who have age-related cataracts will be included in the study. To participate in this study, patients must be at least 18 years old at the time of screening and a maximum preoperative corneal astigmatism of 1.0 D is permitted. All patients who would like to take part in this study will receive an information interview and further detailed study information in written form. Before a patient is admitted, he or she must sign a consent form.
The primary study endpoint is to investigate whether the binocular distance-corrected visual acuity achieved with the study lens for the distance, intermediate and near ranges is not statistically significantly inferior to the parameters achieved with the control lens.
The entire study including data processing will be carried out in accordance with EN ISO 14155:2020 Clinical Investigation of Medical Devices for Human Subjects, EN ISO 11979-7:2018: Clinical investigations of intraocular lenses for the correction of aphakia, EU MDR 2017/745, MEDDEV 2.7.1 rev. 4 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies, MPDG:2020: Medical Device Law Implementation Act, as well as applicable local regulations and the Declaration of Helsinki.
Enrollment
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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
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:
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
Primary purpose
Allocation
Interventional model
Masking
58 participants in 2 patient groups
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Central trial contact
Raquel Willrich Amroussi, M.A
Data sourced from clinicaltrials.gov
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