CataractPHY2110NCT04874376
PMCF Retrospective Study Outcomes of a Premium Monofocal IOL
A study testing IOL implantation experimental (Isopure 1.2.3.) in people with Cataract and Lens Opacities, run by Beaver-Visitec International, Inc. at 6 sites in Spain.
Trial summary
Multicentric, retro- / prospective, open-label, observational PMCF study to investigate visual performance, contrast sensitivity and patient satisfaction after mono- or bilateral implantation of Isopure 1.2.3. intraocular lenses following cataract surgery. Read more about this study
- Who is it for?
- Ages 45 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.)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 6 sitesSpain
- Study dates
- 24 May 2021to 12 Jan 2022
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Male or female adults ages 45 years or older on the day of treatment that were mono- or bilaterally implanted with Isopure 1.2.3. intraocular lens minimum 120 days before the study visit;
- Maximum time between first and second eye treatment: 45 days (this accounts for bilateral implantations only);
- Capability to understand and sign an IRB approved informed consent form and privacy authorization;
- Clear intraocular media;
- Minimum set of retrospective preoperative and intraoperative data available as outlined in the examination matrix;
- Willing and able to conform to the study requirements.
Who cannot join
- • Age of patient <45 years at the day of surgery;
- Time between first and second eye treatment: >45 days (this accounts for bilateral implantations only);
- Subjects who underwent previous intraocular or corneal surgery other than IOL implantation;
- Subjects with diagnosed degenerative visual disorders (e.g. AMD or CME);
- Subjects in whom in-the-bag implantation was not possible;
- Subjects in whom surgical complications occurred (e.g. posterior rupture).
- Subjects showing glaucoma;
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Oftalvist, Alicante
Alicante
Vithas, Alicante
Alicante
Clinica Baviera
Madrid
HM Monteprincipe
Madrid
HM Vallés
Madrid
Augenklinik, Palma de Mallorca
Multiple Locations
About this study
Official title: Clinical Study to Investigate Visual Performance, Contrast Sensitivity and Patient Satisfaction After Implantation of a Premium Monofocal Intraocular Lens
Multicentric, retro- / prospective, open-label, observational PMCF study to investigate visual performance, contrast sensitivity and patient satisfaction after mono- or bilateral implantation of Isopure 1.2.3. intraocular lenses following cataract surgery.
The study treatment itself is not part of this observational clinical investigation. Only patients that already have been implanted with the device under investigation qualify for this retro- prospective observational clinical study.
Read the detailed description
The study is a multicentric, retro- / prospective, open-label, observational PMCF study to investigate visual performance, contrast sensitivity and patient satisfaction after mono- or bilateral implantation of Isopure 1.2.3. intraocular lenses following cataract surgery.
The study treatment itself is not part of this observational clinical investigation. Only patients that already have been implanted with the device under investigation qualify for this retro- prospective observational clinical study.
Isopure 1.2.3. is CE approved and commercially available in the countries this clinical investgation 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 study will be carried out in up to five clinical centers in Spain. 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.
Subjects participating in the trial will attend a total of maximum 1 study visit (from 120 days post-operative). This study visit will be minimum 20 days after the surgery of the 2nd eye. Subjects would have the option for unscheduled visits if required medically.
The primary performance endpoint is to show that the monocular Best Corrected Distance Visual Acuity (CDVA) measured in the study group is statistically non-inferior to outcomes of the monofocal parent lens Micropure 1.2.3. The comparative data is used from the latest Clinical Evaluation Report (CER) for the monofocal Micropure 1.2.3. lens. To avoid bias, only the first implanted eye will be considered for this calculation. Data interim analyses will be done after the last patient finished the 1 study visit postoperative examination to support the study publication plan.
- Conditions
- Cataract, Lens Opacities
- Being tested
- IOL implantation experimental (Isopure 1.2.3.)
- Keywords
- Intraocular Lens, Premium, hydrophobic, IOL, monofocal
- 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 Isopure 12.3 with retrospective data collection
| Study group | Role | What they receive |
|---|---|---|
| IOL retrospective data collection | Experimental | Experimental arm: Premium Monofocal intraocular lens. Receives: Device: IOL implantation experimental (Isopure 1.2.3.) |
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.
No statistically significant difference between the monocular CDVA from 4 months follow up visit when compared to the parent IOL (Micropure 1.2.3). A significance level of 0.025 or lower (p < 0.025) 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: From 120 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start24 May 2021
- Primary completion12 Jan 2022
- Study completion12 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaver-Visitec International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- targomedGmbH
- Responsible party
- Sponsor
- Investigators
- Gonzalo Bernabeu Arias, MD, Principal investigator, HM Monteprincipe, HM Vallés, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874376
- Sponsor's protocol ID
- PHY2110
- Acronym
- PHY2110
- Status last verified
- Jul 2022
- First submitted
- 29 Apr 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morlock 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 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Investigate Visual Performance, Contrast Sensitivity and Patient Satisfaction After Implantation of a Premium Monofocal Intraocular Lens
- ClinicalTrials.gov ID
- NCT04874376
- Acronym / sponsor ID
- PHY2110 / PHY2110
- Conditions
- Cataract, Lens Opacities
- Keywords
- Intraocular Lens, Premium, hydrophobic, IOL, monofocal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Beaver-Visitec International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- targomedGmbH
- Study start
- 24 May 2021 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 12 Jan 2022 (actual)
- First posted
- 5 May 2021 (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.
Multicentric, retro- / prospective, open-label, observational PMCF study to investigate visual performance, contrast sensitivity and patient satisfaction after mono- or bilateral implantation of Isopure 1.2.3. intraocular lenses following cataract surgery.
The study treatment itself is not part of this observational clinical investigation. Only patients that already have been implanted with the device under investigation qualify for this retro- prospective observational clinical study.
Detailed description
The study is a multicentric, retro- / prospective, open-label, observational PMCF study to investigate visual performance, contrast sensitivity and patient satisfaction after mono- or bilateral implantation of Isopure 1.2.3. intraocular lenses following cataract surgery.
The study treatment itself is not part of this observational clinical investigation. Only patients that already have been implanted with the device under investigation qualify for this retro- prospective observational clinical study.
Isopure 1.2.3. is CE approved and commercially available in the countries this clinical investgation 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 study will be carried out in up to five clinical centers in Spain. 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.
Subjects participating in the trial will attend a total of maximum 1 study visit (from 120 days post-operative). This study visit will be minimum 20 days after the surgery of the 2nd eye. Subjects would have the option for unscheduled visits if required medically.
The primary performance endpoint is to show that the monocular Best Corrected Distance Visual Acuity (CDVA) measured in the study group is statistically non-inferior to outcomes of the monofocal parent lens Micropure 1.2.3. The comparative data is used from the latest Clinical Evaluation Report (CER) for the monofocal Micropure 1.2.3. lens. To avoid bias, only the first implanted eye will be considered for this calculation. Data interim analyses will be done after the last patient finished the 1 study visit postoperative examination to support the study publication plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IOL retrospective data collection | Experimental | Device: IOL implantation experimental (Isopure 1.2.3.)Experimental arm: Premium Monofocal intraocular lens. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • Male or female adults ages 45 years or older on the day of treatment that were mono- or bilaterally implanted with Isopure 1.2.3. intraocular lens minimum 120 days before the study visit;
- Maximum time between first and second eye treatment: 45 days (this accounts for bilateral implantations only);
- Capability to understand and sign an IRB approved informed consent form and privacy authorization;
- Clear intraocular media;
- Minimum set of retrospective preoperative and intraoperative data available as outlined in the examination matrix;
Key exclusion criteria (7 listed)
- • Age of patient <45 years at the day of surgery;
- Time between first and second eye treatment: >45 days (this accounts for bilateral implantations only);
- Subjects who underwent previous intraocular or corneal surgery other than IOL implantation;
- Subjects with diagnosed degenerative visual disorders (e.g. AMD or CME);
- Subjects in whom in-the-bag implantation was not possible;
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 Isopure 12.3 with retrospective data collection | Device | IOL retrospective data collection |
Primary outcome
monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions on the first implanted eye.
Time frame: From 120 days postoperative
No statistically significant difference between the monocular CDVA from 4 months follow up visit when compared to the parent IOL (Micropure 1.2.3). A significance level of 0.025 or lower (p < 0.025) 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.
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 20 Jul 2022.
- 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.
Gonzalo Bernabeu Arias, MD principal investigator
HM Monteprincipe, HM Vallés, Madrid, Spain
6 sites 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.) in people with Cataract and Lens Opacities, run by Beaver-Visitec International, Inc. at 6 sites in Spain.
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 6 inclusion and 7 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 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. 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: From 120 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 NCT04874376, which also lists 1 linked publication.
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 20 Jul 2022.