Comparing visual performance of two types of intraocular lenses for cataract surgery
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
This study is testing which of two types of lenses used in cataract surgery helps people see better and feel more satisfied with their vision after the procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hanita Lenses Industry-sponsored |
| Locations | 1 site (Heidelberg, Im Neuenheimer Feld) |
| Trial ID | NCT06084169 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the visual performance of the Hanita Lenses Intensity SL intraocular lens (IOL) with the Alcon Panoptix IOL in patients undergoing cataract surgery. The study will assess various outcomes including binocular distance corrected visual acuity, defocus curve measurements, contrast sensitivity, and patient satisfaction. Approximately 58 patients with bilateral age-related cataracts will participate, attending a total of 10 study visits over a period of 3-7 months. The trial is conducted at a single center in Germany and follows a randomized, unblinded, controlled design.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with bilateral age-related cataracts who are scheduled for cataract surgery.
Not a fit: Patients with retinal or optic nerve diseases or those with significant corneal astigmatism beyond the specified limits may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into which IOL offers better visual outcomes for patients undergoing cataract surgery.
How similar studies have performed: Previous studies comparing different IOLs have shown varying results, but this specific comparison is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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. 1 D if with-the-rule (steep axis is vertical, between 60-120⁰) 2. 0.4 D if against-the-rule (steep axis is horizontal, 0-30⁰ or 150-180⁰) 3. 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: 1. Availability for the follow-up visits - 1 day, 1 week and 1 month after the first surgery 2. Availability for the second surgery - one week to two months after the first surgery 3. 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
Where this trial is running
Heidelberg, Im Neuenheimer Feld
- Universitäts-Augenklinik Heidelberg International Vision Correction Research Centre (IVCRC) — Heidelberg, Im Neuenheimer Feld, Germany (Recruiting)
Study contacts
- Principal investigator: Auffarth Gerd U., Prof. — Universitäts-Augenklinik Heidelberg International Vision Correction Research Centre (IVCRC)
- Study coordinator: Raquel Willrich Amroussi, M.A
- Email: raquel.willrichamroussi@med.uni-heidelberg.de
- Phone: 49 6221 56-36849
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.