Prospective, non-randomised, open, controlled, single-center post-market clinical follow study about Micropure 1.2.3 IOL.
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 bilateral implantation of monofocal intraocular lenses Micropure 1.2.3. (PhysIOL, Liège, Belgium) The study purpose is to obtain clinical data on visual acuity and contrast sensitivity on patients implanted with Micropure 1.2.3. The device under investigation (Micropure 1.2.3.) is a monofocal glistening-free hydrophobic acrylic intraocular lens (IOL) manufactured by the sponsor of this study PhysIOL sa/nv. The IOL will be implanted as part of the routine cataract surgery on patients suffering from cataract development. In total 50 patients will be recruited for this clinical study and receive a bilateral implantation of Micropure 1.2.3. intraocular lens. Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 2 Years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Implantation of intraocular lens (IOL). Name: "MicroPure 1.2.3." It is a monofocal intraocular lens consisting of hydrophobic acrylic material. One IOL per eye will be implanted
Ophtalmology department - CHU liège
Liège, Belgium
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 literature data on a monofocal hydrophilic IOL (Bausch \& Lomb - Akreos MI60) at the 3 months follow up visit.
Time frame: 3 months postoperative
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 11979-7:2014.
Time frame: 1 month, 3 months, 12 months, 24 months postoperative
Monocular and binocular Uncorrected Distance Visual Acuity (UDVA)
UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
Time frame: 1 month, 3 months, 12 months, 24 months postoperative
Monocular and binocular Uncorrected Intermediate Visual Acuity (UIVA)
UIVA is measured with ETDRS charts placed in 70cm distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
Time frame: 1 month, 3 months, 12 months, 24 months postoperative
Monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA)
DCIVA is measured with ETDRS charts placed in 70cm distance and using best distance corrected refraction according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
Time frame: 1 month, 3 months, 12 months, 24 months postoperative
Binocular Corrected Distance Visual Acuity (CDVA)
CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014. This assessment is done binocularly
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Time frame: 1 month, 3 months, 12 months, 24 months postoperative
Monocular and binocular Contrast Sensitivity under photopic and mesopic light conditions
Contrast Sensitivity under photopic and mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision)
Time frame: 1 month, 3 months, 12 months, 24 months postoperative
Monocular and binocular assessment of defocus curve under photopic light conditions
To assess the visual acuity for different distances, defocus curves under photopic light conditions will be measured. This test is performed with best distance corrected refraction and spherical additions ranging from -2.0 D to +1.5 D
Time frame: 1 month, 3 months, 12 months, 24 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.
Time frame: 12 months, 24 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.
Time frame: 12 months, 24 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.
Time frame: 12 months, 24 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.
Time frame: 12 months, 24 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.
Time frame: 12 months, 24 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.
Time frame: 12 months, 24 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.
Time frame: 12 months, 24 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.
Time frame: 12 months, 24 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.
Time frame: 12 months, 24 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.
Time frame: 12 months, 24 months postoperative