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

NCT06084169 | Recruiting DMC

• 1 other identifier: ISL-01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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 the inclusion criteria and provide written informed consent will be enrolled in the study. The main questions it aims to answer are:

1. 1.To show non-inferiority in binocular distance corrected visual acuity for far, intermediate and near distances after Trifocal IOL implantation.
2. 2.To show non-inferiority in the Defocus Curve measurement
3. 3.To show non-inferiority in Contrast Sensitivity measurement
4. 4.To show non-inferiority in patient satisfaction

Conditions

Cataract

Keywords

IOL; Cataract; Hanita Lenses; Alcon; Intensity SL; Panoptix; Intra Ocular Lens

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Defocus Curve

  3 months (90-120 days) post second eye operation

• Contrast Sensitivity

  3 months (90-120 days) post second eye operation

• Patient satisfaction

  3 months (90-120 days) post second eye operation

Study Arms (2)

Intensity SL IOL

ACTIVE COMPARATOR

29 patients will be implanted bilaterally with Intensity SL IOL

Device: Intra Ocular Lens (IOL) Implant

Panoptix IOL

ACTIVE COMPARATOR

29 patients will be implanted bilaterally with PanOptix IOL

Device: Intra Ocular Lens (IOL) Implant

Interventions

Intra Ocular Lens (IOL) Implant DEVICE

Implantable intra ocular lens instead of the cataractous lens has been removed from the patient's eye

Also known as: Panoptix Intra Ocular Lens (IOL) Implant

Intensity SL IOL; Panoptix IOL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• D if with-the-rule (steep axis is vertical, between 60-120⁰)
• D if against-the-rule (steep axis is horizontal, 0-30⁰ or 150-180⁰)
• 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

You may not qualify if:

• Difficulty for cooperation (distance from their home, general health conditions)
• Previous ocular/corneal surgery that may affect refraction accuracy or visual acuity.
• 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.

Sponsors & Collaborators

• Hanita Lenses: lead

Study Sites (1)

Universitäts-Augenklinik Heidelberg International Vision Correction Research Centre (IVCRC)

Heidelberg, Im Neuenheimer Feld, 69120, Germany

RECRUITING

MeSH Terms

Conditions

Cataract

Interventions

Mutagenesis, Insertional

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Protein Engineering; Genetic Engineering; Genetic Techniques; Investigative Techniques; Mutation; Genetic Variation; Genetic Phenomena; Mutagenesis

Study Officials

• Auffarth Gerd U., Prof.

  Universitäts-Augenklinik Heidelberg International Vision Correction Research Centre (IVCRC)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raquel Willrich Amroussi, M.A

CONTACT

49 6221 56-36849; raquel.willrichamroussi@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label Study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will encompass a total of 58 patients: 29 patients will be implanted bilaterally with Intensity SL IOL 29 patients will be implanted bilaterally with PanOptix IOL

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 16, 2023
• Study Start: July 13, 2023
• Primary Completion: December 30, 2025
• Study Completion: March 1, 2026
• Last Updated: September 27, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)