- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03796624
Clinical Outcomes of MICROPURE and PodEye Monofocal Intraocular Lenses (PHY1803)
Comparison of Clinical Outcomes After Implantation of MICROPURE (PhysIOL) and PodEye (PhysIOL) Monofocal Intraocular Lenses Into the Two Eyes of the Same Patient
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Zlin, Czechia, 76001
- Gemini Eye Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Investigational Device Micropure 1.2.3.
Implantation of monofocal intraocular lens (IOL) "Micropure 1.2.3." in one of the eyes of the study subject
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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
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Active Comparator: Comparator PODEYE
Implantation of monofocal intraocular lens (IOL) "PODEYE" in the contralateral eye of the study subject
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
monocular Corrected Distance Visual Acuity (CDVA)
Time Frame: 6 months postoperative
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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.
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6 months postoperative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Manifested refraction
Time Frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
|
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.
|
preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
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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
|
UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2018.
This assessment is performed under photopic light conditions
|
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
|
UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2018.
This assessment is performed under mesopic light conditions
|
preoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
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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
|
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
|
preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
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Monocular Corrected Distance Visual Acuity (CDVA) under mesopic light conditions
Time Frame: preoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
|
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
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preoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
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Monocular Contrast Sensitivity under photopic light conditions
Time Frame: 6 months postoperative
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Contrast Sensitivity under photopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision)
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6 months postoperative
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Monocular Contrast Sensitivity under mesopic light conditions
Time Frame: 6 months postoperative
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Contrast Sensitivity under mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision)
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6 months postoperative
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Slitlamp examination - Corneal status
Time Frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
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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. |
preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
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Slitlamp examination - Fundus
Time Frame: preoperative, 12 months postoperative
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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. |
preoperative, 12 months postoperative
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Slitlamp examination - Signs of inflammation
Time Frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
|
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. |
preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
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Slitlamp examination - Pupillary block
Time Frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
|
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. |
preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
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Slitlamp examination - Retinal detachment
Time Frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
|
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. |
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
|
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. |
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
|
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. |
preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
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Slitlamp examination IOL tilt
Time Frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
|
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. |
preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
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Slitlamp examination - IOL discoloration
Time Frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
|
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. |
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
|
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. |
preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intraocular pressure (IOP) measurement
Time Frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
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The IOP will be measured with non-contact tonometer as part of the routine follow up examinations
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preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
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Questionnaire on IOL implantation
Time Frame: peroperative
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A questionnaire will be handed out to the surgeon right after the surgery to document the ease of use and possible issues during IOL implantation.
These data will be used to compare the outcomes to different surgery techniques or injectors.
The questionnaire is not validated and the outcomes serve only for the sponsor to receive feedback if one or the other IOL is easier to implant.
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peroperative
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Keratometry
Time Frame: preoperative
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Keratometric measurements are performed to calculate the required IOL power
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preoperative
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Biometry
Time Frame: preoperative
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Biometry measurements are performed to calculate the required IOL power
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preoperative
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Collaborators and Investigators
Investigators
- Principal Investigator: Pavel Stodulka, MD, PhD, Gemini Eye Clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHY1803
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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