CataractPHY2130NCT05235139
PMCF Study on Comparison of EDOF Lenses (Switzerland)
A study testing IOL implantation experimental (ISOPURE 1.2.3.) and IOL implantation active comparator (Acrysof Vivity) in people with Cataract and Lens Opacities, run by Beaver-Visitec International, Inc. at 1 site in Switzerland.
Trial summary
Single center, prospective, randomised, controlled, double-blind post-market clinical follow-up (PMCF) study to compare the clinical outcomes of a premium monofocal intraocular lens (PhysIOL ISOPURE 1.2.3.) with clinical data obtained in a control group implanted with an EDOF IOL (Alcon Acrysof IQ Vivity). Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Lens Opacities
- What is being tested?
- IOL implantation experimental (ISOPURE 1.2.3.) and IOL implantation active comparator (Acrysof Vivity)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Mar 2022to 22 Aug 2023
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cataractous eyes with no comorbidity;
- Calculated IOL power is within the range of the study IOLs;
- Male or female adults ages 50 years or older on the day of screening who have cataract(s) in one or both eyes;
- Regular total corneal astigmatism ≤1.0 D (measured by topography method)
- Clear intraocular media other than cataract;
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures;
- Expected postoperative Best Corrected Distance Visual Acuity (CDVA) ≤ 0.2 logMAR;
- Signed informed consent.
Who cannot join
- Age of patient < 50 years;
- Regular total corneal astigmatism >1.0 dioptres (measured by topography method)
- Irregular astigmatism;
- Difficulty for cooperation (distance from their home, general health conditions);
- Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders);
- Subjects who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema or macula pucker;
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- Previous intraocular or corneal surgery or intravitreal injection;
- Traumatic cataract;
- History or presence of macular edema;
- Glaucoma with visual field defects;
- Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic / scotopic conditions);
- Amblyopia with monocular preoperative CDVA of >0.1 logMAR;
- Cornea guttata;
- Keratoconus;
- Chronic uveitis;
- Expected complicated surgery;
- Significant dry eye;
- Contra-indications as listed in the current Instructions for use (IFU);
- Contra-indication or unwillingness to perform immediate sequential bilateral cataract surgery;
- Concurrent or previous (within 60 days) participation in another drug or device investigation.
- In addition to above mentioned in- and exclusion criteria, subjects shall be discontinued when certain conditions are present at the time of surgery, including:
- zonular instability or defect;
- capsular fibrosis or other opacity; and
- inability to fixate IOL in desired position. In such cases, the subject shall be followed until the condition has stabilized.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Post-Market Clinical Follow-Up (PMCF) Study to Investigate the Clinical Outcomes of a Premium Monofocal Intraocular Lens (IOL) in Comparison to an EDOF Lens
Single center, prospective, randomised, controlled, double-blind post-market clinical follow-up (PMCF) study to compare the clinical outcomes of a premium monofocal intraocular lens (PhysIOL ISOPURE 1.2.3.) with clinical data obtained in a control group implanted with an EDOF IOL (Alcon Acrysof IQ Vivity).
Read the detailed description
This is a single center, prospective, randomised, controlled, double-blind post-market clinical follow-up (PMCF) study whereby patients undergoing routine cataract surgery will have bilateral implantation of premium monofocal intraocular lenses (PhysIOL ISOPURE 1.2.3.) or EDOF lenses (Alcon Acrysof IQ Vivity). The patients will be randomized in a 1:1 ratio to receive the study or control lenses. Both IOLs, investigational device and control device, are CE approved and commercially available in the countries this clinical investigation is being carried out. The investigational device and all study products, including the devices used for the study examinations, will be used within the intended use specifications from the manufacturer. In addition, no invasive or other burdening examinations will occur for the patient.
The device under investigation (ISOPURE 1.2.3.) is a hydrophobic, glistening-free, acrylic premium monofocal intraocular lens (IOL) manufactured by the sponsor of this study, PhysIOL sa/nv. The control lens (Alcon Acrysof IQ Vivity) is a non-diffractive Extended Vision Posterior Chamber IOL.
The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.
Subjects participating in the trial will attend a total of 6 study visits (1 preoperative, 1 operative and 4 postoperative) over a period of 6 months. Subjects would have the option for unscheduled visits if required medically.
Primary and secondary endpoint data will be collected at the 120-180 days follow up visit.
- Conditions
- Cataract, Lens Opacities
- Being tested
- IOL implantation experimental (ISOPURE 1.2.3.), IOL implantation active comparator (Acrysof Vivity)
- Keywords
- Intraocular Lens, EDOF, hydrophobic, IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOL implantation experimental (ISOPURE 1.2.3.)Device
Implantation of premium monofocal IOL ISOPURE 1.2.3.
IOL implantation active comparator (Acrysof Vivity)Device
Implantation of EDOF IOL Acrysof Vivity
| Study group | Role | What they receive |
|---|---|---|
| IOL implantation experimental | Experimental | Experimental arm: Premium monofocal intraocular lens. Receives: Device: IOL implantation experimental (ISOPURE 1.2.3.) |
| IOL implantation active comparator | Active comparator | Comparator arm: EDOF intraocular lens. Receives: Device: IOL implantation active comparator (Acrysof Vivity) |
What is being measured
The primary outcome is the main question the study is designed to answer.
monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions on the first implanted eye.
Non inferiority of ISOPURE 1.2.3. outcomes compared to the Acrysof IQ Vivity outcomes in terms of monocular Best Corrected Distance Visual Acuity (CDVA) by means of statistical significance.
A significance level of 0.05 or lower (p < 0.05) will be considered statistically significant. CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018.
Measured: 6 months (120-180 days) postoperative
Secondary outcomes (1)
Safety (Rates of Adverse Events)
The objective is to compare the SPE (Safety and Performance Endpoints) rates of the investigational product to the results of historical data of EN ISO 11979-7:2018, Annex E (Table E.2)
Measured: 1 day (1-2 days) postoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start9 Mar 2022
- Primary completion22 Aug 2023
- Study completion22 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaver-Visitec International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- targomedGmbH
- Responsible party
- Sponsor
- Investigators
- Kristof Vandekerkchove, MD, Principal investigator, Eye center Vista Alpina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235139
- Sponsor's protocol ID
- PHY2130
- Acronym
- PHY2130
- Status last verified
- May 2024
- First submitted
- 18 Jan 2022
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26.
PubMed 20505205Morlock R, Wirth RJ, Tally SR, Garufis C, Heichel CWD. Patient-Reported Spectacle Independence Questionnaire (PRSIQ): Development and Validation. Am J Ophthalmol. 2017 Jun;178:101-114. doi: 10.1016/j.ajo.2017.03.018. Epub 2017 Mar 22.
PubMed 28341605
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Post-Market Clinical Follow-Up (PMCF) Study to Investigate the Clinical Outcomes of a Premium Monofocal Intraocular Lens (IOL) in Comparison to an EDOF Lens
- ClinicalTrials.gov ID
- NCT05235139
- Acronym / sponsor ID
- PHY2130 / PHY2130
- Conditions
- Cataract, Lens Opacities
- Keywords
- Intraocular Lens, EDOF, hydrophobic, IOL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Beaver-Visitec International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- targomedGmbH
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 22 Aug 2023 (actual)
- Study completion
- 22 Aug 2023 (actual)
- First posted
- 11 Feb 2022 (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.
Single center, prospective, randomised, controlled, double-blind post-market clinical follow-up (PMCF) study to compare the clinical outcomes of a premium monofocal intraocular lens (PhysIOL ISOPURE 1.2.3.) with clinical data obtained in a control group implanted with an EDOF IOL (Alcon Acrysof IQ Vivity).
Detailed description
This is a single center, prospective, randomised, controlled, double-blind post-market clinical follow-up (PMCF) study whereby patients undergoing routine cataract surgery will have bilateral implantation of premium monofocal intraocular lenses (PhysIOL ISOPURE 1.2.3.) or EDOF lenses (Alcon Acrysof IQ Vivity). The patients will be randomized in a 1:1 ratio to receive the study or control lenses. Both IOLs, investigational device and control device, are CE approved and commercially available in the countries this clinical investigation is being carried out. The investigational device and all study products, including the devices used for the study examinations, will be used within the intended use specifications from the manufacturer. In addition, no invasive or other burdening examinations will occur for the patient.
The device under investigation (ISOPURE 1.2.3.) is a hydrophobic, glistening-free, acrylic premium monofocal intraocular lens (IOL) manufactured by the sponsor of this study, PhysIOL sa/nv. The control lens (Alcon Acrysof IQ Vivity) is a non-diffractive Extended Vision Posterior Chamber IOL.
The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.
Subjects participating in the trial will attend a total of 6 study visits (1 preoperative, 1 operative and 4 postoperative) over a period of 6 months. Subjects would have the option for unscheduled visits if required medically.
Primary and secondary endpoint data will be collected at the 120-180 days follow up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IOL implantation experimental | Experimental | Device: IOL implantation experimental (ISOPURE 1.2.3.)Experimental arm: Premium monofocal intraocular lens. |
| IOL implantation active comparator | Active comparator | Device: IOL implantation active comparator (Acrysof Vivity)Comparator arm: EDOF intraocular lens. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Cataractous eyes with no comorbidity;
- Calculated IOL power is within the range of the study IOLs;
- Male or female adults ages 50 years or older on the day of screening who have cataract(s) in one or both eyes;
- Regular total corneal astigmatism ≤1.0 D (measured by topography method)
- Clear intraocular media other than cataract;
Key exclusion criteria (24 listed)
- Age of patient < 50 years;
- Regular total corneal astigmatism >1.0 dioptres (measured by topography method)
- Irregular astigmatism;
- Difficulty for cooperation (distance from their home, general health conditions);
- Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders);
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 |
|---|---|---|
| IOL implantation experimental (ISOPURE 1.2.3.)Implantation of premium monofocal IOL ISOPURE 1.2.3. | Device | IOL implantation experimental |
| IOL implantation active comparator (Acrysof Vivity)Implantation of EDOF IOL Acrysof Vivity | Device | IOL implantation active comparator |
Primary outcome
monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions on the first implanted eye.
Time frame: 6 months (120-180 days) postoperative
Non inferiority of ISOPURE 1.2.3. outcomes compared to the Acrysof IQ Vivity outcomes in terms of monocular Best Corrected Distance Visual Acuity (CDVA) by means of statistical significance. A significance level of 0.05 or lower (p < 0.05) will be considered statistically significant. CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018.
1 secondary outcome
Safety (Rates of Adverse Events)
Time frame: 1 day (1-2 days) postoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Background: PubMed 20505205McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26.
- Background: PubMed 28341605Morlock R, Wirth RJ, Tally SR, Garufis C, Heichel CWD. Patient-Reported Spectacle Independence Questionnaire (PRSIQ): Development and Validation. Am J Ophthalmol. 2017 Jun;178:101-114. doi: 10.1016/j.ajo.2017.03.018. Epub 2017 Mar 22.
- 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.
Kristof Vandekerkchove, MD principal investigator
Eye center Vista Alpina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IOL implantation experimental (ISOPURE 1.2.3.) and IOL implantation active comparator (Acrysof Vivity) in people with Cataract and Lens Opacities, run by Beaver-Visitec International, Inc. at 1 site in Switzerland.
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 8 inclusion and 24 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: finished, as of the sponsor's last update on 9 May 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions on the first implanted eye. (time frame: 6 months (120-180 days) postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05235139, which also lists 2 linked publications.
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 9 May 2024.