CataractNCT06084169
Investigation for Assessing the Visual Performance of Hanita Lenses Intensity SL IOL in Comparison to Alcon Panoptix IOL
A study testing Intra Ocular Lens (IOL) Implant in people with Cataract, run by Hanita Lenses at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Intra Ocular Lens (IOL) Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteGermany
- Study dates
- 13 Jul 2023to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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.
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Universitäts-Augenklinik Heidelberg International Vision Correction Research Centre (IVCRC)
Heidelberg, Im Neuenheimer Feld, 69120
Raquel Willrich Amroussi, M.A, +4962215636849, raquel.willrichamroussi@med.uni-heidelberg.de
About this study
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
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:
Read more
- 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.
Read the 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.
- Conditions
- Cataract
- Being tested
- Intra Ocular Lens (IOL) Implant
- Keywords
- IOL, Cataract, Hanita Lenses, Alcon, Intensity SL, Panoptix, Intra Ocular Lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra Ocular Lens (IOL) ImplantDevice
Also called Panoptix Intra Ocular Lens (IOL) Implant
Implantable intra ocular lens instead of the cataractous lens has been removed from the patient's eye
| Study group | Role | What they receive |
|---|---|---|
| Intensity SL IOL | Active comparator | 29 patients will be implanted bilaterally with Intensity SL IOL Receives: Device: Intra Ocular Lens (IOL) Implant |
| Panoptix IOL | Active comparator | 29 patients will be implanted bilaterally with PanOptix IOL Receives: Device: Intra Ocular Lens (IOL) Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months (90-120 days) post second eye operation
Secondary outcomes (3)
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.
Measured: 3 months (90-120 days) post second eye operation
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.
Measured: 3 months (90-120 days) post second eye operation
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.
Measured: 3 months (90-120 days) post second eye operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start13 Jul 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanita Lenses
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Auffarth Gerd U., Prof., Principal investigator, Universitäts-Augenklinik Heidelberg International Vision Correction Research Centre (IVCRC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084169
- Sponsor's protocol ID
- ISL-01
- Status last verified
- Oct 2023
- First submitted
- 4 Oct 2023
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06084169
- Acronym / sponsor ID
- ISL-01
- Conditions
- Cataract
- Keywords
- IOL, Cataract, Hanita Lenses, Alcon, Intensity SL, Panoptix, Intra Ocular Lens
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Hanita LensesIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Intensity SL IOL | Active comparator | Device: Intra Ocular Lens (IOL) Implant29 patients will be implanted bilaterally with Intensity SL IOL |
| Panoptix IOL | Active comparator | Device: Intra Ocular Lens (IOL) Implant29 patients will be implanted bilaterally with PanOptix IOL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra Ocular Lens (IOL) ImplantAlso: Panoptix Intra Ocular Lens (IOL) ImplantImplantable intra ocular lens instead of the cataractous lens has been removed from the patient's eye | Device | Intensity SL IOL, Panoptix IOL |
Primary outcome
Binocular distance corrected visual acuity
Time frame: 3 months (90-120 days) post second eye operation
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 secondary outcomes
Defocus Curve
Time frame: 3 months (90-120 days) post second eye operation
Contrast Sensitivity
Time frame: 3 months (90-120 days) post second eye operation
Patient satisfaction
Time frame: 3 months (90-120 days) post second eye operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Auffarth Gerd U., Prof. principal investigator
Universitäts-Augenklinik Heidelberg International Vision Correction Research Centre (IVCRC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra Ocular Lens (IOL) Implant in people with Cataract, run by Hanita Lenses at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raquel Willrich Amroussi, M.A (49 6221 56-36849, raquel.willrichamroussi@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binocular distance corrected visual acuity (time frame: 3 months (90-120 days) post second eye operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.