search
Back to results

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

Primary Purpose

Cataract

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Intra Ocular Lens (IOL) Implant
Sponsored by
Hanita Lenses
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring IOL, Cataract, Hanita Lenses, Alcon, Intensity SL, Panoptix, Intra Ocular Lens

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intensity SL IOL

Panoptix IOL

Arm Description

29 patients will be implanted bilaterally with Intensity SL IOL

29 patients will be implanted bilaterally with PanOptix IOL

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 4, 2023
Last Updated
October 10, 2023
Sponsor
Hanita Lenses
search

1. Study Identification

Unique Protocol Identification Number
NCT06084169
Brief Title
Investigation for Assessing the Visual Performance of Hanita Lenses Intensity SL IOL in Comparison to Alcon Panoptix IOL
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2023 (Actual)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanita Lenses

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
IOL, Cataract, Hanita Lenses, Alcon, Intensity SL, Panoptix, Intra Ocular Lens

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Masking Description
Open Label Study
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intensity SL IOL
Arm Type
Active Comparator
Arm Description
29 patients will be implanted bilaterally with Intensity SL IOL
Arm Title
Panoptix IOL
Arm Type
Active Comparator
Arm Description
29 patients will be implanted bilaterally with PanOptix IOL
Intervention Type
Device
Intervention Name(s)
Intra Ocular Lens (IOL) Implant
Other Intervention Name(s)
Panoptix Intra Ocular Lens (IOL) Implant
Intervention Description
Implantable intra ocular lens instead of the cataractous lens has been removed from the patient's eye
Primary Outcome Measure Information:
Title
Binocular distance corrected visual acuity
Description
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.
Time Frame
3 months (90-120 days) post second eye operation
Secondary Outcome Measure Information:
Title
Defocus Curve
Description
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.
Time Frame
3 months (90-120 days) post second eye operation
Title
Contrast Sensitivity
Description
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.
Time Frame
3 months (90-120 days) post second eye operation
Title
Patient satisfaction
Description
To show non-inferiority in patient satisfaction by using the modified VF-14 questionnaire for quality of life, in addition to satisfaction questionnaire.
Time Frame
3 months (90-120 days) post second eye operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raquel Willrich Amroussi, M.A
Phone
+49 6221 56-36849
Email
raquel.willrichamroussi@med.uni-heidelberg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Auffarth Gerd U., Prof.
Organizational Affiliation
Universitäts-Augenklinik Heidelberg International Vision Correction Research Centre (IVCRC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitäts-Augenklinik Heidelberg International Vision Correction Research Centre (IVCRC)
City
Heidelberg
State/Province
Im Neuenheimer Feld
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raquel Willrich Amroussi, M.A
Phone
+4962215636849
Email
raquel.willrichamroussi@med.uni-heidelberg.de

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs