CataractPHY1803NCT03796624
Clinical Outcomes of MICROPURE and PodEye Monofocal Intraocular Lenses
A study testing Micropure 1.2.3. and PODEYE in people with Cataract and Lens Opacities, run by Beaver-Visitec International, Inc. at 1 site in Czechia.
Trial summary
Prospective, non-randomised, open, controlled, single-center post-market clinical follow study about Micropure 1.2.3. and PODEYE intraocular lenses. 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?
- Micropure 1.2.3. and PODEYE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteCzechia
- Study dates
- 12 Feb 2019to 17 Jun 2021
- 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
- Cataractous eyes with no comorbidity
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- Clear intraocular media other than cataract;
- Signed informed consent
Who cannot join
- Age of patient < 45 years;
- Irregular astigmatism;
- Regular corneal astigmatism >0.75 dioptres by an automatic keratometer or biometer or >1.0 dioptres if the steep axis of cylinder is between 90° and 120°;
- Difficulty for cooperation (distance from their home, general health condition);
- Previous intraocular or corneal surgery;
- Traumatic cataract;
- Any ocular comorbidity;
- Instability of keratometry or biometry measurements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Clinical Outcomes After Implantation of MICROPURE (PhysIOL) and PodEye (PhysIOL) Monofocal Intraocular Lenses Into the Two Eyes of the Same Patient
Prospective, non-randomised, open, controlled, single-center post-market clinical follow study about Micropure 1.2.3. and PODEYE intraocular lenses.
Read the detailed description
This clinical investigation is a prospective, non-randomised, open, controlled, single-center post-market clinical follow whereby study patients undergoing routine cataract surgery will have implantation of monofocal intraocular lens Micropure 1.2.3. (PhysIOL, Liège, Belgium) in one eye and implantation of monofocal intraocular lens PODEYE (PhysIOL, Liège, Belgium) in the contralateral eye of the same patient.
The study purpose is to obtain clinical data on visual acuity and contrast sensitivity on patients implanted with Micropure 1.2.3. and PODEYE
The devices under investigation (Micropure 1.2.3. and PODEYE) are a monofocal glistening-free hydrophobic acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv. The optical properties of the lenses are very comparable. The main difference is the mechanical design of the haptics, that is not expected to have an influence on the clinical outcomes.
The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.
In total 76 patients will be recruited for this clinical study and receive the implantation of Micropure 1.2.3. and POPDEYE intraocular lenses.
Subjects participating in the trial will attend study visits over a period of 12 months.
- Conditions
- Cataract, Lens Opacities
- Being tested
- Micropure 1.2.3., PODEYE
- Keywords
- Intraocular lens, Monofocal, Hydrophobic
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micropure 1.2.3.Device
Implantation of intraocular lens (IOL). Name: "MicroPure 1.2.3." It is a monofocal intraocular lens consisting of hydrophobic acrylic material. One IOL per patient will be implanted
PODEYEDevice
Implantation of intraocular lens (IOL). Name: "PODEYE" It is a monofocal intraocular lens consisting of hydrophobic acrylic material. The IOL will be implanted in the contralateral eye of the same patient already implanted with Micropure 1.2.3.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Device Micropure 1.2.3. | Experimental | Implantation of monofocal intraocular lens (IOL) "Micropure 1.2.3." in one of the eyes of the study subject Receives: Device: Micropure 1.2.3. |
| Comparator PODEYE | Active comparator | Implantation of monofocal intraocular lens (IOL) "PODEYE" in the contralateral eye of the study subject Receives: Device: PODEYE |
What is being measured
The primary outcome is the main question the study is designed to answer.
monocular Corrected Distance Visual Acuity (CDVA)
Statistically non-inferior visual acuity outcomes on monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions compared to eyes implanted with the comparator PODEYE at the 6 months follow up visit.
Measured: 6 months postoperative
Secondary outcomes (17)
Manifested refraction
The manifested refraction is measured by means of a phoropter. The data contains values for sphere, cylinder and axis of cylinder according to ISO 11979-7:2018.
Measured: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions
UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2018. This assessment is performed under photopic light conditions
Measured: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Monocular Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions
UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2018. This assessment is performed under mesopic light conditions
Measured: preoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions
CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018. This assessment is performed under photopic light conditions
Measured: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Monocular Corrected Distance Visual Acuity (CDVA) under mesopic light conditions
CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018. This assessment is performed under mesopic light conditions
Measured: preoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Monocular Contrast Sensitivity under photopic light conditions
Contrast Sensitivity under photopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision)
Measured: 6 months postoperative
Monocular Contrast Sensitivity under mesopic light conditions
Contrast Sensitivity under mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision)
Measured: 6 months postoperative
Slitlamp examination - Corneal status
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
- Corneal status.
Measured: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Slitlamp examination - Fundus
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
- Fundus.
Measured: preoperative, 12 months postoperative
Slitlamp examination - Signs of inflammation
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
- Signs of inflammation.
Measured: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Slitlamp examination - Pupillary block
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
- Pupillary block.
Measured: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Slitlamp examination - Retinal detachment
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
- Retinal detachment.
Measured: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Slitlamp examination - Status of anterior and posterior capsule
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
- Status of anterior and posterior capsule.
Measured: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Slitlamp examination - IOL decentration
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
- IOL decentration.
Measured: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Slitlamp examination IOL tilt
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
- IOL tilt.
Measured: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Slitlamp examination - IOL discoloration
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
- IOL discoloration.
Measured: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Slitlamp examination - IOL opacity
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
- IOL opacity.
Measured: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start12 Feb 2019
- Primary completion17 Jun 2021
- Study completion17 Jun 2021
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
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaver-Visitec International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pavel Stodůlka, MD, PhD, Principal investigator, Gemini Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796624
- Sponsor's protocol ID
- PHY1803
- Acronym
- PHY1803
- Status last verified
- Jul 2021
- First submitted
- 4 Jan 2019
- Last updated
- 9 Jul 2021
- 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 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Outcomes After Implantation of MICROPURE (PhysIOL) and PodEye (PhysIOL) Monofocal Intraocular Lenses Into the Two Eyes of the Same Patient
- ClinicalTrials.gov ID
- NCT03796624
- Acronym / sponsor ID
- PHY1803 / PHY1803
- Conditions
- Cataract, Lens Opacities
- Keywords
- Intraocular lens, Monofocal, Hydrophobic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Beaver-Visitec International, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 17 Jun 2021 (actual)
- Study completion
- 17 Jun 2021 (actual)
- First posted
- 8 Jan 2019 (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.
Prospective, non-randomised, open, controlled, single-center post-market clinical follow study about Micropure 1.2.3. and PODEYE intraocular lenses.
Detailed description
This clinical investigation is a prospective, non-randomised, open, controlled, single-center post-market clinical follow whereby study patients undergoing routine cataract surgery will have implantation of monofocal intraocular lens Micropure 1.2.3. (PhysIOL, Liège, Belgium) in one eye and implantation of monofocal intraocular lens PODEYE (PhysIOL, Liège, Belgium) in the contralateral eye of the same patient.
The study purpose is to obtain clinical data on visual acuity and contrast sensitivity on patients implanted with Micropure 1.2.3. and PODEYE
The devices under investigation (Micropure 1.2.3. and PODEYE) are a monofocal glistening-free hydrophobic acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv. The optical properties of the lenses are very comparable. The main difference is the mechanical design of the haptics, that is not expected to have an influence on the clinical outcomes.
The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.
In total 76 patients will be recruited for this clinical study and receive the implantation of Micropure 1.2.3. and POPDEYE intraocular lenses.
Subjects participating in the trial will attend study visits over a period of 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Device Micropure 1.2.3. | Experimental | Device: Micropure 1.2.3.Implantation of monofocal intraocular lens (IOL) "Micropure 1.2.3." in one of the eyes of the study subject |
| Comparator PODEYE | Active comparator | Device: PODEYEImplantation of monofocal intraocular lens (IOL) "PODEYE" in the contralateral eye of the study subject |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cataractous eyes with no comorbidity
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- Clear intraocular media other than cataract;
- Signed informed consent
Key exclusion criteria (8 listed)
- Age of patient < 45 years;
- Irregular astigmatism;
- Regular corneal astigmatism >0.75 dioptres by an automatic keratometer or biometer or >1.0 dioptres if the steep axis of cylinder is between 90° and 120°;
- Difficulty for cooperation (distance from their home, general health condition);
- Previous intraocular or corneal surgery;
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 |
|---|---|---|
| Micropure 1.2.3.Implantation of intraocular lens (IOL). Name: "MicroPure 1.2.3." It is a monofocal intraocular lens consisting of hydrophobic acrylic material. One IOL per patient will be implanted | Device | Investigational Device Micropure 1.2.3. |
| PODEYEImplantation of intraocular lens (IOL). Name: "PODEYE" It is a monofocal intraocular lens consisting of hydrophobic acrylic material. The IOL will be implanted in the contralateral eye of the same patient already implanted with Micropure 1.2.3. | Device | Comparator PODEYE |
Primary outcome
monocular Corrected Distance Visual Acuity (CDVA)
Time frame: 6 months postoperative
Statistically non-inferior visual acuity outcomes on monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions compared to eyes implanted with the comparator PODEYE at the 6 months follow up visit.
17 secondary outcomes
Manifested refraction
Time frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions
Time frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Monocular Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions
Time frame: preoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions
Time frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Monocular Corrected Distance Visual Acuity (CDVA) under mesopic light conditions
Time frame: preoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Monocular Contrast Sensitivity under photopic light conditions
Time frame: 6 months postoperative
Monocular Contrast Sensitivity under mesopic light conditions
Time frame: 6 months postoperative
Slitlamp examination - Corneal status
Time frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Slitlamp examination - Fundus
Time frame: preoperative, 12 months postoperative
Slitlamp examination - Signs of inflammation
Time frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Slitlamp examination - Pupillary block
Time frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Slitlamp examination - Retinal detachment
Time frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Slitlamp examination - Status of anterior and posterior capsule
Time frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Slitlamp examination - IOL decentration
Time frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Slitlamp examination IOL tilt
Time frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Slitlamp examination - IOL discoloration
Time frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Slitlamp examination - IOL opacity
Time frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months 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 Jul 2021.
- 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.
Pavel Stodůlka, MD, PhD principal investigator
Gemini Eye Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micropure 1.2.3. and PODEYE in people with Cataract and Lens Opacities, run by Beaver-Visitec International, Inc. at 1 site in Czechia.
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 4 inclusion and 8 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 Jul 2021. 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 Czechia. 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) (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 9 Jul 2021.