Clinical Outcomes of MICROPURE and PodEye Monofocal Intraocular Lenses

Study Overview
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Brief Summary
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Prospective, non-randomised, open, controlled, single-center post-market clinical follow study about Micropure 1.2.3. and PODEYE intraocular lenses.

Detailed Description
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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.

Official Title
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Comparison of Clinical Outcomes After Implantation of MICROPURE (PhysIOL) and PodEye (PhysIOL) Monofocal Intraocular Lenses Into the Two Eyes of the Same Patient

Conditions
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Cataract, Lens Opacities

Intervention / Treatment
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* Device: Micropure 1.2.3.
* Device: PODEYE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Device Micropure 1.2.3.<br>Implantation of monofocal intraocular lens (IOL) Micropure 1.2.3. in one of the eyes of the study subject | Device: Micropure 1.2.3.<br>* 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<br>|
| Active Comparator: Comparator PODEYE<br>Implantation of monofocal intraocular lens (IOL) PODEYE in the contralateral eye of the study subject | Device: PODEYE<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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 | 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 | 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) | 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) | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraocular lens, Monofocal, Hydrophobic