Controlled, open label, prospective Post Market Clinical Follow-Up, single-center clinical study to investigate visual performance after implantation of a trifocal IOL (PhysIOL Pod L GF) in patients that underwent refractive surgery.
This clinical investigation is a controlled, open label, prospective Post Market Clinical Follow-Up, single-center clinical study whereby patients undergoing routine cataract surgery that previously underwent refractive surgery prior to being screened will have bilateral implantation of trifocal intraocular lens FineVision POD L GF (PhysIOL, Liège, Belgium). The study purpose is to collect clinical data on visual acuity, contrast sensitivity and patient reported outcomes obtained on patients with cataracts and/or suffering from presbyopia that underwent refractive surgery prior to the IOL implantation. The device under investigation (FineVision POD L GF) is a trifocal 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 28 patients will be recruited for this clinical study and receive a bilateral implantation of FineVision POD L GF intraocular lens. Subjects participating in the trial will attend a total of 9 study visits (1 preoperative, 2 operative and 6 postoperative) over a period of 6 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Implantation of trifocal IOL POD L GF consisting of hydrophobic material
Monocular Best Corrected Distance Visual Acuity (CDVA)
Statistically significant non-inferiority with POD L GF on monocular CDVA in comparison to literature data. A significance level of 0.05 will be considered statistically significant.
Time frame: 6 months (120-180 days) postoperative
Manifest refraction (sphere and cylinder)
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: Pre-OP, 1-2 days post operative, 30-60 days postoperative, 120-180 days postoperative
Pupil Size Photopic
Photopic pupil diameters are measured with a precision of at least +/-0.5 mm. For the photopic pupil diameters, eye illumination should be identical to that used for photopic contrast sensitivity testing. It is required that pupil measurements be made with an infrared pupillometer / CCD camera. Pupil measurements should only be made after the eye has had time to fully adapt to the testing conditions (at least 10 minutes).
Time frame: 120-180 days postoperative
Pupil Size Mesopic
Mesopic pupil diameters are measured with a precision of at least +/-0.5 mm. For the mesopic pupil diameters, eye illumination should be identical to that used for mesopic contrast sensitivity testing. It is required that pupil measurements be made with an infrared pupillometer / CCD camera. Pupil measurements should only be made after the eye has had time to fully adapt to the testing conditions (at least 10 minutes).
Time frame: 120-180 days postoperative
Uncorrected Distance Visual Acuity (UDVA) - monocular
UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions
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Time frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Uncorrected Distance Visual Acuity (UDVA) - binocular
UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.
Time frame: 120-180 days postoperative
Corrected Distance Visual Acuity (CDVA) - monocular
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 monocularly under photopic conditions.
Time frame: Pre-OP, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Corrected Distance Visual Acuity (CDVA) - binocular
Monocular and Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) under photopic and mesopic light conditions at 80cm distance
Time frame: 120-180 days postoperative
Uncorrected Intermediate Visual Acuity at 80cm (UIVA) - monocular
UIVA is measured with ETDRS charts placed in 80cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions.
Time frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative
Uncorrected Intermediate Visual Acuity at 80cm (UIVA) - binocular
UIVA is measured with ETDRS charts placed in 80cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.
Time frame: 120-180 days postoperative
Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA) - monocular
DCIVA is measured with ETDRS charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions.
Time frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative
Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA) - binocular
DCIVA is measured with ETDRS charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.
Time frame: 120-180 days postoperative
Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA) - monocular mesopic
DCIVA is measured with ETDRS charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under mesopic conditions
Time frame: 120-180 days postoperative
Uncorrected Intermediate Visual Acuity at 66cm (UIVA) - monocular
UIVA is measured with ETDRS charts placed in 66cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions.
Time frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative
Uncorrected Intermediate Visual Acuity at 66cm (UIVA) - binocular
UIVA is measured with ETDRS charts placed in 66cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.
Time frame: 120-180 days postoperative
Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA) - monocular
DCIVA is measured with ETDRS charts placed in 66cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions.
Time frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative
Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA) - binocular
DCIVA is measured with ETDRS charts placed in 66cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.
Time frame: 120-180 days postoperative
Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA) - monocular mesopic.
DCIVA is measured with ETDRS charts placed in 66cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under mesopic conditions
Time frame: 120-180 days postoperative
Uncorrected Near Visual Acuity at 40cm (UNVA) - monocular
UNVA is measured with ETDRS charts placed in 40cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions
Time frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative
Uncorrected Near Visual Acuity at 40cm (UNVA) - binocular
UNVA is measured with ETDRS charts placed in 40cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions
Time frame: 120-180 days postoperative
Distance Corrected Near Visual Acuity at 40cm (DCNVA) - monocular
DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions
Time frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative
Distance Corrected Near Visual Acuity at 40cm (DCNVA) - binocular
DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions
Time frame: 120-180 days postoperative
Distance Corrected Near Visual Acuity at 40cm (DCNVA) - monocular mesopic
DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under mesopic conditions
Time frame: 120-180 days postoperative
Defocus Curve
To assess the visual acuity for different distances, defocus curves under photopic light conditions are measured. This test is performed with best distance corrected refraction and spherical additions ranging from -4.0 D to +2.0 D. This examination is performed binocularly
Time frame: 120-180 days postoperative
Binocular Contrast Sensitivity under photopic light conditions
Contrast Sensitivity under photopic light conditions using the standardized contrast sensitivity device Clinical Trial Suite (M\&S Technologies). This examination is performed binocularly.
Time frame: 120-180 days postoperative
Binocular Contrast Sensitivity under mesopic light conditions
Contrast Sensitivity under mesopic light conditions using the standardized contrast sensitivity device Clinical Trial Suite (M\&S Technologies). This examination is performed binocularly.
Time frame: 120-180 days postoperative
Binocular Contrast Sensitivity under mesopic light conditions and using a glare source
Contrast Sensitivity under mesopic light conditions with a glare source using the standardized contrast sensitivity device Clinical Trial Suite (M\&S Technologies). This examination is performed binocularly.
Time frame: 120-180 days postoperative
Patient reported outcomes: Quality of Vision Questionnaire (QoV) quality of vision
Quality of vision based on response to each question in the Quality of Vision (QoV) questionnaire. Answer is a choice of 4 options, the first being the least and the fourth being the most based on question type, i.e. "never" to "very often" or "not at all" to "severe".
Time frame: 120-180 days postoperative
Patient reported outcomes: Near Activity Visual Questionnaire (NAVQ) quality of vision
Quality of vision based on response (choice of 0-3 with 0 meaning no difficulty and 3 meaning extreme difficulty) to each question in the Near Activity Visual Questionnaire (NAVQ)
Time frame: 120-180 days postoperative
Slit lamp 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: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Fundus examination with dilated pupil
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: Pre Op, 120-180 days postoperative
Slit lamp 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 Anterior chamber cells, Anterior chamber flare, Cystoid macular oedema, Hypopyon, and Endophthalmitis
Time frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Slit lamp 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: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Slit lamp 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: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Slit lamp 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: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Slit lamp 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: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Slit lamp 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: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Slit lamp 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: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Slit lamp 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: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative