CataractNCT03297372
Visual Performance Intraocular Lens (IOL) MicroPure 1.2.3.
A study testing IOL implantation in people with Cataract and Lens Opacities, run by Beaver-Visitec International, Inc. at 2 sites in Italy.
Trial summary
The clinical investigation is a post-market clinical follow up study whereby patients undergoing routine cataract surgery will have monolateral implantation of a commercially available, CE approved monofocal intraocular lens MicroPure 1.2.3. (PhysIOL, Liège, Belgium). Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Cataract, Lens Opacities
- What is being tested?
- IOL implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 2 sitesItaly
- Study dates
- 23 Oct 2017to 8 Sep 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cataractous eyes with no comorbidity
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- Signed informed consent
Who cannot join
- Irregular astigmatism
- Age of patient < 45 years
- Regular corneal astigmatism > 0.75 D on study eye as measured by an automatic keratometer (regularity determined by the topography of the keratometry)
- Difficulty for cooperation (distance from their home, general health condition)
- Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)
- Any ocular comorbidity
Show all 10Show fewer
- History of ocular trauma or prior ocular surgery including refractive procedures
- Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
- Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
- Complicated surgery
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Azienda Ospedaliera San Giovanni Addolorata - presidio Britannico
Rome, 00184
Fondazione GB Bietti - IRCCS
Rome, 00198
About this study
Official title: Clinical Study to Investigate Visual Performance of Hydrophobic Monofocal IOL: MicroPure 1.2.3.
The clinical investigation is a post-market clinical follow up study whereby patients undergoing routine cataract surgery will have monolateral implantation of a commercially available, CE approved monofocal intraocular lens MicroPure 1.2.3. (PhysIOL, Liège, Belgium).
Read the detailed description
The examinations consist of visual acuity data, contrast sensitivity exams, slitlamp examinations and posterior capsule opacification (PCO) grading.
Follow up will be up to 24 months postoperative.
- Conditions
- Cataract, Lens Opacities
- Being tested
- IOL implantation
- Keywords
- Intraocular lens, monofocal, cataract, PhysIOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOL implantationDevice
Implantation of monofocal IOL Micropure 1.2.3
| Study group | Role | What they receive |
|---|---|---|
| IOL Implantation experimental | Experimental | Implantation of Micropure 1.2.3. in one of the eyes of the study subject Receives: Device: IOL implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
monocular Corrected Distance Visual Acuity (CDVA) under photopic conditions
The primary study end point is to show statistically equal visual acuity outcomes on monocular Corrected Distance Visual Acuity (CDVA) under photopic conditions compared to literature data on a monofocal hydrophobic IOL (Alcon - Acrysof SN60AT).
Measured: 6 months postoperative
Secondary outcomes (4)
Posterior capsule opacification (PCO) grading
grade of the PCO determined by slitlamp
Measured: 2 years postoperative
Uncorrected Distance Visual acuity (UDVA)
Monocular Uncorrected Distance Visual acuity (UDVA)
Measured: 6 months postoperative
Contrast Sensitivity
Contrast Sensitivity under photopic and mesopic light conditions
Measured: 6 months postoperative
Glistening assessment
Assessment of glistenings by slitlamp determination
Measured: 2 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start23 Oct 2017
- Primary completion8 Sep 2022
- Study completion8 Sep 2022
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaver-Visitec International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Domenico Schiano, MD, Principal investigator, Fondazione GB Bietti - IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297372
- Sponsor's protocol ID
- PHY1604
- Status last verified
- Oct 2022
- First submitted
- 26 Sep 2017
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Investigate Visual Performance of Hydrophobic Monofocal IOL: MicroPure 1.2.3.
- ClinicalTrials.gov ID
- NCT03297372
- Acronym / sponsor ID
- PHY1604
- Conditions
- Cataract, Lens Opacities
- Keywords
- Intraocular lens, monofocal, cataract, PhysIOL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Beaver-Visitec International, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 8 Sep 2022 (actual)
- Study completion
- 8 Sep 2022 (actual)
- First posted
- 29 Sep 2017 (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 clinical investigation is a post-market clinical follow up study whereby patients undergoing routine cataract surgery will have monolateral implantation of a commercially available, CE approved monofocal intraocular lens MicroPure 1.2.3. (PhysIOL, Liège, Belgium).
Detailed description
The examinations consist of visual acuity data, contrast sensitivity exams, slitlamp examinations and posterior capsule opacification (PCO) grading.
Follow up will be up to 24 months postoperative.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IOL Implantation experimental | Experimental | Device: IOL implantationImplantation of Micropure 1.2.3. in one of the eyes of the study subject |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cataractous eyes with no comorbidity
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- Signed informed consent
Key exclusion criteria (10 listed)
- Irregular astigmatism
- Age of patient < 45 years
- Regular corneal astigmatism > 0.75 D on study eye as measured by an automatic keratometer (regularity determined by the topography of the keratometry)
- Difficulty for cooperation (distance from their home, general health condition)
- Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)
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 implantationImplantation of monofocal IOL Micropure 1.2.3 | Device | IOL Implantation experimental |
Primary outcome
monocular Corrected Distance Visual Acuity (CDVA) under photopic conditions
Time frame: 6 months postoperative
The primary study end point is to show statistically equal visual acuity outcomes on monocular Corrected Distance Visual Acuity (CDVA) under photopic conditions compared to literature data on a monofocal hydrophobic IOL (Alcon - Acrysof SN60AT).
4 secondary outcomes
Posterior capsule opacification (PCO) grading
Time frame: 2 years postoperative
Uncorrected Distance Visual acuity (UDVA)
Time frame: 6 months postoperative
Contrast Sensitivity
Time frame: 6 months postoperative
Glistening assessment
Time frame: 2 years 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 28 Oct 2022.
- 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.
Domenico Schiano, MD principal investigator
Fondazione GB Bietti - IRCCS
2 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 in people with Cataract and Lens Opacities, run by Beaver-Visitec International, Inc. at 2 sites in Italy.
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 3 inclusion and 10 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 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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 Corrected Distance Visual Acuity (CDVA) under photopic conditions (time frame: 6 months postoperative). 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 28 Oct 2022.