Investigation for Assessing the Visual Performance of Hanita Lenses Intensity SL IOL in Comparison to Alcon Panoptix IOL

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06084169
• Other study ID #: ISL-01
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: October 2023
• Source: Hanita Lenses
• Contact: Raquel Willrich Amroussi, M.A
• Phone: +49 6221 56-36849
• Email: raquel.willrichamroussi[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 the inclusion criteria and provide written informed consent will be enrolled in the study.

The main questions it aims to answer are:

1. To show non-inferiority in binocular distance corrected visual acuity for far, intermediate and near distances after Trifocal IOL implantation.

2. To show non-inferiority in the Defocus Curve measurement

3. To show non-inferiority in Contrast Sensitivity measurement

4. To show non-inferiority in patient satisfaction

Participants will attend a total of 10 study visits: 1 preoperative visit, 2 operations and 7 postoperative visits.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: March 1, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 60-120°)

2. 0.4 D if against-the-rule (steep axis is horizontal, 0-30° or 150-180°)

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Intra Ocular Lens (IOL) Implant
Implantable intra ocular lens instead of the cataractous lens has been removed from the patient's eye

Locations

Country	Name	City	State
Germany	Universitäts-Augenklinik Heidelberg International Vision Correction Research Centre (IVCRC)	Heidelberg	Im Neuenheimer Feld

Sponsors (1)

Lead Sponsor	Collaborator
Hanita Lenses

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binocular distance corrected visual acuity	To show non-inferiority in binocular distance corrected visual acuity for far, intermediate and near distances after Trifocal IOL implantation.; Visual acuity will be performed by using ETDRS charts. All results will be expressed in logMAR. Visual acuity will be measured in photopic conditions.	3 months (90-120 days) post second eye operation
Secondary	Defocus Curve	To show non-inferiority in the Defocus Curve measurement by using ETDRS charts. 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.	3 months (90-120 days) post second eye operation
Secondary	Contrast Sensitivity	To show non-inferiority in Contrast Sensitivity measurement by using VectorVision at mesopic and photopic conditions.; 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.	3 months (90-120 days) post second eye operation
Secondary	Patient satisfaction	To show non-inferiority in patient satisfaction by using the modified VF-14 questionnaire for quality of life, in addition to satisfaction questionnaire.	3 months (90-120 days) post second eye operation