Status:
RECRUITING
Investigation for Assessing the Visual Performance of Hanita Lenses Intensity SL IOL in Comparison to Alcon Panoptix IOL
Lead Sponsor:
Hanita Lenses
Conditions:
Cataract
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed 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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT06084169
Start Date
July 13 2023
End Date
March 1 2026
Last Update
September 27 2024
Active Locations (1)
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1
Universitäts-Augenklinik Heidelberg International Vision Correction Research Centre (IVCRC)
Heidelberg, Im Neuenheimer Feld, Germany, 69120