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| Name | Class |
|---|---|
| targomedGmbH | INDUSTRY |
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The study will be a multicentric, prospective open-label ethics committee approved clinical study to investigate safety, visual outcomes, contrast sensitivity and rotational stability after bilateral implantation of Isatis TF IOL following cataract surgery.
This is a staged, multicentric, controlled, prospective, open-label clinical study whereby patients undergoing routine cataract surgery will have bilateral implantation of hydrophobic acrylic refractive trifocal intraocular lenses (Isatis TF) or the monofocal control device Isatis.
The investigational device, Control lens and all study products, including the devices used for the study examinations, will be used within the intended use specifications from the manufacturer. In addition, no invasive or other burdening examinations will occur for the patient.
The study will be carried out in up to five clinical centers in Spain.
The device under investigation is a hydrophobic acrylic trifocal intraocular lens (IOL) manufactured by the sponsor of this study. The trifocality of this investigational device is based on a purely refractive principle with the goal to provide additional near and intermediate visual acuity with low photic side effects. The IOLs will be implanted in the course of routine cataract surgery and will benefit to patients suffering from cataract development.
The control device (Isatis) is a hydrophobic acrylic monofocal intraocular lens to be implanted during cataract surgery. This control lens is CE approved and commercially available in Spain. Isatis monofocal lens is the parent lens of the device under investigation and both lenses share mechanical and material properties.
In total 180 patients will be recruited for this clinical study and undergo bilateral implantation of the Isatis TF intraocular lens or Isatis lens in a 2:1 ratio. Subjects participating in the trial will attend a total of maximum 11 study visits over a period of 11-13 months. Subjects would have the option for unscheduled visits if required medically.
Data analyses will be performed after the last patient finished the 120-180 days postoperative examination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IOL implantation experimental | Experimental | Experimental arm: Trifocal intraocular lens Isatis TF |
|
| IOL implantation active comparator | Active Comparator | Comparator arm: Monofocal intraocular lens Isatis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of trifocal IOL, Isatis TF (device under investigation) | Device | Patients will be implanted with study IOL in both eyes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint: Rates of Adverse Events | The objective is to compare the SPE (Safety and Performance Endpoints) rates of the investigational product to reference data stated in the according ISO standard for posterior intraocular lenses (EN ISO 11979-7:2018) based on minimum 100 subjects. | 120-180 days postoperative |
| Primary Performance Endpoint: Best Corrected Distance Visual Acuity | The primary performance endpoint is to show non inferiority of Isatis TF compared to the monofocal comparator in terms of best corrected distance visual acuity (CDVA) by means of statistical significance. | 120-180 days postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Safety Endpoint: Best Corrected Distance Visual Acuity compared to historical data | The objective is to compare best corrected distance visual acuities (CDVA) above defined thresholds of the investigational product to the normative data stated in the according ISO norm (EN ISO 11979-7:2018) for posterior chamber intraocular lenses. | 120-180 days postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions | Monocular UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions. | Preoperative, 1-2 days postoperative; 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative |
Inclusion Criteria:
Exclusion Criteria:
In addition to above mentioned in- and exclusion criteria, subjects shall be discontinued when certain conditions are present at the time of surgery, including:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gemini Eye Clinic Ostrava | Ostrava | 700 30 | Czechia | |||
| Gemini Eye Clinic Praha-Krc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20505205 | Background | McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26. | |
| 28341605 | Background | Morlock R, Wirth RJ, Tally SR, Garufis C, Heichel CWD. Patient-Reported Spectacle Independence Questionnaire (PRSIQ): Development and Validation. Am J Ophthalmol. 2017 Jun;178:101-114. doi: 10.1016/j.ajo.2017.03.018. Epub 2017 Mar 22. |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Implantation of monofocal IOL, Isatis (control device) | Device | Patients will be implanted with Control IOL in both eyes |
|
| Secondary Performance Endpoint: Distance Corrected Near Visual Acuity (DCNVA) | Secondary performance endpoint is to show a statistically significant increase between pre-and postoperative findings on monocular Distance Corrected Near Visual Acuity (DCNVA) under photopic light conditions on the first implanted eye. | 120-180 days postoperative |
| Secondary Performance Endpoint: Distance Corrected Intermediate Visual Acuity (DCIVA) | Secondary performance endpoint is to show a statistically significant increase between pre-and postoperative findings on monocular Distance Corrected Intermediate Visual Acuity (DCIVA) under photopic light conditions on the first implanted eye. | 120-180 days postoperative |
| Binocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions | Binocular UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions. | 120-180 days postoperative, 330-420 days postoperative |
| Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions | Monocular CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions. | Preoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative |
| Monocular Corrected Distance Visual Acuity (CDVA) under mesopic light conditions | Monocular CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018. This assessment is done binocularly under mesopic light conditions. | 120-180 days postoperative |
| Binocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions | Binocular CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions. | 120-180 days postoperative |
| Monocular Uncorrected Intermediate Visual Acuity (UIVA) under photopic light conditions | Monocular UIVA is measured with ETDRS charts placed in 66cm distance according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions. | 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative |
| Binocular Uncorrected Intermediate Visual Acuity (UIVA) under photopic light conditions | Binocular UIVA is measured with ETDRS charts placed in 66cm distance according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions. | 120-180 days postoperative, 330-420 days postoperative |
| Monocular Uncorrected Near Visual Acuity (UNVA) under photopic light conditions | Monocular UNVA is measured with ETDRS charts placed in 40cm distance according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions. | 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative |
| Binocular Uncorrected Near Visual Acuity (UNVA) under photopic light conditions | Binocular UNVA is measured with ETDRS charts placed in 40cm distance according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions. | 120-180 days postoperative, 330-420 days postoperative |
| Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) under photopic light conditions | Monocular DCIVA is measured with ETDRS charts placed in 66cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions. | Preoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative |
| Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) under mesopic light conditions | Monocular DCIVA is measured with ETDRS charts placed in 66cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done binocularly under mesopic light conditions. | 120-180 days postoperative |
| Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) under photopic light conditions | Binocular DCIVA is measured with ETDRS charts placed in 66cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions. | 120-180 days postoperative |
| Monocular Distance Corrected Near Visual Acuity (DCNVA) under photopic light conditions | Monocular DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions. | Preoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative |
| Monocular Distance Corrected Near Visual Acuity (DCNVA) under mesopic light conditions | Monocular DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done binocularly under mesopic light conditions. | 120-180 days postoperative |
| Binocular Distance Corrected Near Visual Acuity (DCNVA) under photopic light conditions | Binocular DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions. | 120-180 days postoperative |
| Manifest refraction | The manifest 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. This data will also be used to calculate the manifest refractive spherical equivalent (MRSE) | Preoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative |
| Adjusted Mean Refractive Spherical Equivalent (MRSE) | The predictability of the postoperative manifest refraction will be evaluated using the absolute value of the adjusted MRSE calculated by the following formula: MRSEadjusted = MRSEpostop - MRSEtarget. | 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative |
| Binocular 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 -4.5 D to +2.0 D in 0.5 D steps. This examination is performed binocularly. | 120-180 days postoperative |
| Binocular Contrast Sensitivity under photopic light conditions | Contrast Sensitivity under photopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision). This examination is performed binocularly. | 120-180 days postoperative |
| Binocular Contrast Sensitivity under mesopic light conditions | Contrast Sensitivity under mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision). This examination is performed binocularly. | 120-180 days postoperative |
| Binocular Contrast Sensitivity under photopic light conditions and using a glare source | Contrast Sensitivity under photopic light conditions with a glare source using the standardized contrast sensitivity device CSV-1000 (VectorVision). This examination is performed binocularly. | 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 CSV-1000 (VectorVision). This examination is performed binocularly. | 120-180 days postoperative |
| Patient reported outcomes - Quality of Vision questionnaire [McAlinden et al, 2010] | To assess the subjective perception of disturbances by photic phenomena, the validated and verified Quality of Vision (QoV) questionnaire will be used. This questionnaire is a linear-scaled 30-item instrument and is designed with 10 symptoms rated in each of three scales (frequency, severity, and bothersome). The QoV Questionnaire provides a QoV score in terms of symptom frequency, severity, and bothersome [McAlinden et al, 2010]. | preoperative, 120-180 days postoperative |
| Patient reported outcomes - Catquest-9SF 2011 questionnaire [Lundström et al, 2009] | To assess if difficulties in daily life occur due to impaired sight. This questionnaire is a 9-item Rasch-scaled instrument to assess subjective perception of visual impairment after surgery [Lundström et al, 2009]. | preoperative, 120-180 days postoperative |
| Patient reported outcomes - Patient-Reported Spectacle Independence Questionnaire (PRSIQ) [Morlock et al, 2017] | The PRSIQ is a patient-reported measure assessing spectacle independence following cataract surgery. The analyses conducted provide evidence for the use of the PRSIQ total score as a measure of spectacle independence [Morlock et al, 2017]. | preoperative, 120-180 days postoperative |
| Pupil Size under photopic light conditions | Photopic pupil diameters are measured with a ruler allowing for a precision of at least +/-0.5 mm. In addition to the measurement with a ruler, pupil diameters under photopic light conditions will be recorded from the preoperative Pentacam measurement. For the photopic pupil diameters, eye illumination should be identical to that used for photopic contrast sensitivity testing. Pupil measurements should only be made after the eye has had time to fully adapt to the testing conditions (at least 5 minutes). The examination is performed and documented according to the guidelines in ISO 11979-7:2018. | preoperative, 120-180 days postoperative |
| Pupil Size under mesopic light conditions | Mesopic pupil diameters are measured with a ruler allowing for 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. Pupil measurements should only be made after the eye has had time to fully adapt to the testing conditions (at least 5 minutes). The examination is performed and documented according to the guidelines in ISO 11979-7:2018. | preoperative, 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 | preoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days 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, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative |
| Slitlamp examination - Iris 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: • Iris Status | Preoperative, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days 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:
| Preoperative, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days 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. | 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days 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, 30-60 days postoperative, 120-180 days postoperative, 330-420 days 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. | 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days 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. | 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days 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. | 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days 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. | 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days 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. | 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative |
| Intraocular pressure (IOP) measurement | The IOP will be measured with non-contact tonometer as part of the routine follow up examinations. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. | Preoperative, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative |
| Keratometry | Keratometric measurements are performed to calculate the required IOL power. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. | Preoperative |
| IOL power and target refraction | The parameter of the implanted IOL must be recorded as well as the target refraction given by the IOL calculator. This parameter is needed to calculate the accuracy of achieving the target refraction. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. | day of surgery |
| Fundus OCT | An OCT (optical coherence tomography) image will be taken at the preoperative visit to identify AMD suspicious eyes that need to be excluded from this study. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. | Preoperative |
| Biometry | Biometry measurements are performed to calculate the required IOL power. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. | Preoperative |
| Corneal topography | Pentacam device (Oculus, Germany) will be used to perform corneal topography. This examination is needed to exclude patients showing an irregular corneal astigmatism. | Preoperative |
| Corneal aberrometry | Pentacam device (Oculus, Germany) will be used to perform corneal aberrometry measurement. The following values will be evaluated in this study: Spherical aberrations, high order aberrations. | Preoperative |
| IOL rotation | To determine the rotational stability of the lenses after implantation, the actual IOL orientation has to be recorded as the intended surgical position during surgery using a photograph through the surgery microscope or within one hour after surgery using a photograph through a slit lamp to document the rotational position of the IOL. Additional orientations are measured and recorded at the follow up visits by taking retroilluminated photographs in mydriasis using the slit lamp. To determine the rotational stability, it is important that the IOL axis marks of the IOL are visible as well as concurrent structures of the eye (in the same image) that are fixed and stable. Preferred fixed structures are limbal vessels. The pupil is dilated if necessary to visualize the IOL axis marks. | day of surgery, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative |
| Halo and glare scores | A Halo and Glare simulator software (Eyeland Design Network GmbH, Germany) will be used to assess the subjective perception of photic phenomena. The patients will be asked to adjust the halo and glare level in a simulated image to the amount they perceive of such photic phenomena. This test is performed pre- and postoperatively. The preoperative outcomes serve as a baseline measurement. | Preoperative, 120-180 days postoperative, 330-420 days postoperative |
| Prague |
| 140 00 |
| Czechia |
| Gemini Eye Clinic Zlín | Zlín | 760 01 | Czechia |
| Hospital Donostia | Donostia / San Sebastian | 20014 | Spain |
| Oftalvist Madrid | Madrid | 28006 | Spain |
| Hospital Universitario Clínico San Carlos | Madrid | 28040 | Spain |
| Hospital Miguel Servet | Zaragoza | 50009 | Spain |
| 19251145 | Background | Lundstrom M, Pesudovs K. Catquest-9SF patient outcomes questionnaire: nine-item short-form Rasch-scaled revision of the Catquest questionnaire. J Cataract Refract Surg. 2009 Mar;35(3):504-13. doi: 10.1016/j.jcrs.2008.11.038. |