Clinical Outcomes of MICROPURE and PodEye Monofocal Intraocular Lenses
- Conditions
- CataractLens Opacities
- Interventions
- Device: PODEYEDevice: Micropure 1.2.3.
- Registration Number
- NCT03796624
- Lead Sponsor
- Beaver-Visitec International, Inc.
- Brief Summary
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Comparator PODEYE PODEYE Implantation of monofocal intraocular lens (IOL) "PODEYE" in the contralateral eye of the study subject Investigational Device Micropure 1.2.3. Micropure 1.2.3. Implantation of monofocal intraocular lens (IOL) "Micropure 1.2.3." in one of the eyes of the study subject
- Primary Outcome Measures
Name Time Method monocular Corrected Distance Visual Acuity (CDVA) 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.
- Secondary Outcome Measures
Name Time Method Manifested refraction 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.
Slitlamp examination - Signs of inflammation 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.Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions 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
Monocular Corrected Distance Visual Acuity (CDVA) under mesopic light conditions 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
Monocular Contrast Sensitivity under photopic light conditions 6 months postoperative Contrast Sensitivity under photopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision)
Monocular Contrast Sensitivity under mesopic light conditions 6 months postoperative Contrast Sensitivity under mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision)
Slitlamp examination - Fundus preoperative, 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:
• Fundus.Slitlamp examination - Pupillary block 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.Slitlamp examination - Retinal detachment 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.Slitlamp examination IOL tilt 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.Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions 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
Monocular Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions 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
Slitlamp examination - Corneal status 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:
• Corneal status.Slitlamp examination - Status of anterior and posterior capsule 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.Slitlamp examination - IOL opacity 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.Slitlamp examination - IOL decentration 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.Slitlamp examination - IOL discoloration 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.
Trial Locations
- Locations (1)
GEMINI Eye Clinic
🇨🇿Zlin, Czechia