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PMCF Study on EDOF (Isopure) vs Monofocal (Micropure) IOL (PHY2001)

Primary Purpose

Cataract, Lens Opacities

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
IOL implantation experimental (Isopure 1.2.3.)
IOL implantation active comparator (Micropure 1.2.3.)
Sponsored by
Beaver-Visitec International, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Intraocular Lens, EDOF, hydrophobic, IOL, monofocal

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Cataractous eyes with no comorbidity;
  • Calculated IOL power is within the range of the study IOLs;
  • Male or female adults ages 45 years or older on the day of screening who have cataract(s) in one or both eyes;
  • Regular corneal astigmatism ≤1.0 D (measured by an automatic keratometer)
  • Clear intraocular media other than cataract;
  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures;
  • Signed informed consent.

Exclusion Criteria:

  • Age of patient < 45 years;
  • Regular corneal astigmatism >1.0 dioptres (measured by an automatic keratometer)
  • Irregular astigmatism;
  • Difficulty for cooperation (distance from their home, general health conditions);
  • Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse;
  • Subjects with AMD suspicious eyes as determined by OCT examination;
  • Subjects who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema;
  • Previous intraocular or corneal surgery;
  • Traumatic cataract;
  • History or presence of macular edema;
  • Instability of keratometry or biometry measurements;
  • Ocular hypertension or glaucoma;
  • Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic / scotopic conditions);
  • Expected complicated surgery;
  • Significant dry eye.

Sites / Locations

  • Hanusch Krankenhaus
  • Gemini Eye Clinic
  • Augen-Zentrum-Nordwest
  • Universitäts-Augenklinik Heidelberg
  • Smile Eyes Augen + Laserzentrum
  • Augentagesklinik Rheine
  • Institute of Eye Surgery - Clane
  • Institute of Eye Surgery
  • Asian Eye Institute
  • Oftalvist Alicante
  • Miranza IOA Madrid
  • Hospital Clínico San Carlos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IOL implantation experimental

IOL implantation active comparator

Arm Description

Experimental arm: Enhanced depth of focus (EDOF) intraocular lens.

Comparator arm: Monofocal intraocular lens.

Outcomes

Primary Outcome Measures

monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions on the first implanted eye.
No statistically significant difference between the two study groups on monocular CDVA at 4-6 months follow up visit. A significance level of 0.05 or lower (p < 0.05) will be considered statistically significant. CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018.

Secondary Outcome Measures

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. This data will also be used to calculate the manifested refractive spherical equivalent (MRSE)
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.
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.
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.
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.
Monocular Corrected Distance Visual Acuity (low contrast CDVA) using low contrast (10%) optotypes under photopic light conditions
Monocular CDVA using low contrast (10%) optotypes 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. This test is performed using a low-contrast acuity chart with 10% contrast (using the Weber definition: [background - optotype]/background).
Monocular Uncorrected Intermediate Visual Acuity at 80cm (UIVA@80cm) under photopic light condition
Monocular UIVA@80cm is measured with ETDRS charts placed in 80cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.
Binocular Uncorrected Intermediate Visual Acuity at 80cm (UIVA@80cm) under photopic light condition
Binocular UIVA@80cm is measured with ETDRS charts placed in 80cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.
Monocular Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA@80cm) under photopic light conditions
Monocular DCIVA@80cm is measured with ETDRS charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.
Binocular Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA@80cm) under photopic light conditions
Binocular DCIVA@80cm is measured with ETDRS charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.
Monocular Distance Corrected Distance Visual Acuity at 80cm (low contrast DCIVA@80cm) using low contrast (10%) optotypes under photopic light conditions
Monocular DCIVA@80cm using low contrast (10%) optotypes 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. This test is performed using a low-contrast acuity chart with 10% contrast (using the Weber definition: [background - optotype]/background).
Monocular Uncorrected Intermediate Visual Acuity at 66cm (UIVA@66cm) under photopic light condition
Monocular UIVA@66cm is measured with ETDRS charts placed in 66cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.
Binocular Uncorrected Intermediate Visual Acuity at 66cm (UIVA@66cm) under photopic light condition
Binocular UIVA@66cm is measured with ETDRS charts placed in 66cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.
Monocular Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA@66cm) under photopic light conditions
Monocular DCIVA@66cm 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.
Binocular Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA@66cm) under photopic light conditions
Binocular DCIVA@66cm 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.
Monocular Distance Corrected Distance Visual Acuity at 66cm (low contrast DCIVA@66cm) using low contrast (10%) optotypes under photopic light conditions
Monocular DCIVA@80cm using low contrast (10%) optotypes 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. This test is performed using a low-contrast acuity chart with 10% contrast (using the Weber definition: [background - optotype]/background).
Binocular Distance Corrected Near Visual Acuity at 40cm (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.
Monocular 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 -2.5 D to +1.5 D in 0.5 D steps. In addition the following vergence values are measured: -0.25 D and +0.25 D. This examination is performed monocularly.
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 -2.5 D to +1.5 D in 0.5 D steps. In addition the following vergence values are measured: -0.25 D and +0.25 D. This examination is performed binocularly.
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.
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.
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.
Halo and Glare Simulator
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 such photic phenomena. This test is performed pre- and postoperatively. The preoperative outcomes deal as a baseline measurement.
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].
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 9-item Rasch-scaled instrument to assess subjective perception of visual impairment after surgery [Lundström et al, 2009].
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].
Aberrometry
Aberrometry outcomes are measured with a standard aberrometer. The following values will be evaluated in this study: Spherical aberrations, high order aberrations, lens tilt.
Pupil Size under photopic light conditions
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). The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
Pupil Size under mesopic light conditions
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). The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
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
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
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 Anterior chamber cells, Anterior chamber flare, Cystoid macular oedema, Hypopyon, and Endophthalmitis.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 28, 2020
Last Updated
September 29, 2023
Sponsor
Beaver-Visitec International, Inc.
Collaborators
targomedGmbH
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1. Study Identification

Unique Protocol Identification Number
NCT04249492
Brief Title
PMCF Study on EDOF (Isopure) vs Monofocal (Micropure) IOL
Acronym
PHY2001
Official Title
Multicentric Post-Market Clinical Follow-up (PMCF) Investigation to Determine Safety and Efficacy of a Hydrophobic EDOF Intraocular Lens (IOL) in Comparison to a Monofocal IOL
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 11, 2020 (Actual)
Primary Completion Date
February 23, 2023 (Actual)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beaver-Visitec International, Inc.
Collaborators
targomedGmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Multicenter, prospective, randomised, controlled, single-blind post-market clinical follow-up (PMCF) study to compare the clinical outcomes of an enhanced depth of focus (EDOF) IOL with the outcomes obtained with a monofocal lens. Implantation of the IOLs is bilaterally.
Detailed Description
This is a multicenter, prospective, randomised, controlled, single-blind post-market clinical follow-up (PMCF) study whereby patients undergoing routine cataract surgery will have bilateral implantation of Enhanced Depth of Focus intraocular lenses (Isopure 1.2.3.) or monofocal lenses (Micropure 1.2.3.). The patients will be randomized in a 1:1 ratio to receive the study or control lenses. Both IOLs, investigational device and control device, are CE approved and commercially available in the countries this clinical investigation is being carried out. The investigational device 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 Europe and Asia. The device under investigation (Isopure 1.2.3.) is a hydrophobic, glistening-free, acrylic EDOF intraocular lens (IOL) manufactured by the sponsor of this study, PhysIOL sa/nv. The control lens is the parent IOL, belonging to the same IOL family of this manufacturer. It is a hydrophobic, glistening-free, acrylic monofocal IOL (Micropure 1.2.3.). The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development. Subjects participating in the trial will attend a total of maximum 11 study visits (1 preoperative, 1 or 2 operative and up to 8 postoperative) over a period of 12 months. If local requirements allow, preoperative and operative visit can be done on the same day. Subjects would have the option for unscheduled visits if required medically. Primary endpoint data will be collected at the 120-180 days follow up visit. Secondary endpoint data will be collected at the 330-420 days follow up visit. Data interim analyses will be done after the last patient finished the 120-180 days postoperative examination to support the study publication plan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Lens Opacities
Keywords
Intraocular Lens, EDOF, hydrophobic, IOL, monofocal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Single-blind masking; Patient will not be informed which IOL model was implanted until end of the study.
Allocation
Randomized
Enrollment
244 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IOL implantation experimental
Arm Type
Experimental
Arm Description
Experimental arm: Enhanced depth of focus (EDOF) intraocular lens.
Arm Title
IOL implantation active comparator
Arm Type
Active Comparator
Arm Description
Comparator arm: Monofocal intraocular lens.
Intervention Type
Device
Intervention Name(s)
IOL implantation experimental (Isopure 1.2.3.)
Intervention Description
Implantation of trifocal IOL POD F GF consisting of light distribution order: far > intermediate > near
Intervention Type
Device
Intervention Name(s)
IOL implantation active comparator (Micropure 1.2.3.)
Intervention Description
Implantation of trifocal IOL POD F GF consisting of light distribution order: far > near > intermediate
Primary Outcome Measure Information:
Title
monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions on the first implanted eye.
Description
No statistically significant difference between the two study groups on monocular CDVA at 4-6 months follow up visit. A significance level of 0.05 or lower (p < 0.05) will be considered statistically significant. CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018.
Time Frame
6 months (120-180 days) postoperative
Secondary Outcome Measure Information:
Title
Manifested refraction
Description
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. This data will also be used to calculate the manifested refractive spherical equivalent (MRSE)
Time Frame
Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Title
Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions
Description
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.
Time Frame
Preoperative, 1 day (1-2 days) postoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Title
Binocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions
Description
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.
Time Frame
6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Title
Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions
Description
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.
Time Frame
Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Title
Binocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions
Description
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.
Time Frame
6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Title
Monocular Corrected Distance Visual Acuity (low contrast CDVA) using low contrast (10%) optotypes under photopic light conditions
Description
Monocular CDVA using low contrast (10%) optotypes 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. This test is performed using a low-contrast acuity chart with 10% contrast (using the Weber definition: [background - optotype]/background).
Time Frame
1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Title
Monocular Uncorrected Intermediate Visual Acuity at 80cm (UIVA@80cm) under photopic light condition
Description
Monocular UIVA@80cm is measured with ETDRS charts placed in 80cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.
Time Frame
1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Title
Binocular Uncorrected Intermediate Visual Acuity at 80cm (UIVA@80cm) under photopic light condition
Description
Binocular UIVA@80cm is measured with ETDRS charts placed in 80cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.
Time Frame
6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Title
Monocular Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA@80cm) under photopic light conditions
Description
Monocular DCIVA@80cm is measured with ETDRS charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.
Time Frame
1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Title
Binocular Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA@80cm) under photopic light conditions
Description
Binocular DCIVA@80cm is measured with ETDRS charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.
Time Frame
6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Title
Monocular Distance Corrected Distance Visual Acuity at 80cm (low contrast DCIVA@80cm) using low contrast (10%) optotypes under photopic light conditions
Description
Monocular DCIVA@80cm using low contrast (10%) optotypes 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. This test is performed using a low-contrast acuity chart with 10% contrast (using the Weber definition: [background - optotype]/background).
Time Frame
1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Title
Monocular Uncorrected Intermediate Visual Acuity at 66cm (UIVA@66cm) under photopic light condition
Description
Monocular UIVA@66cm is measured with ETDRS charts placed in 66cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.
Time Frame
1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Title
Binocular Uncorrected Intermediate Visual Acuity at 66cm (UIVA@66cm) under photopic light condition
Description
Binocular UIVA@66cm is measured with ETDRS charts placed in 66cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.
Time Frame
6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Title
Monocular Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA@66cm) under photopic light conditions
Description
Monocular DCIVA@66cm 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.
Time Frame
1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Title
Binocular Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA@66cm) under photopic light conditions
Description
Binocular DCIVA@66cm 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.
Time Frame
6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Title
Monocular Distance Corrected Distance Visual Acuity at 66cm (low contrast DCIVA@66cm) using low contrast (10%) optotypes under photopic light conditions
Description
Monocular DCIVA@80cm using low contrast (10%) optotypes 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. This test is performed using a low-contrast acuity chart with 10% contrast (using the Weber definition: [background - optotype]/background).
Time Frame
1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Title
Binocular Distance Corrected Near Visual Acuity at 40cm (DCNVA) under photopic light conditions
Description
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.
Time Frame
6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Title
Monocular Defocus Curve
Description
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 -2.5 D to +1.5 D in 0.5 D steps. In addition the following vergence values are measured: -0.25 D and +0.25 D. This examination is performed monocularly.
Time Frame
1 month (30-60 days) postoperative
Title
Binocular Defocus Curve
Description
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 -2.5 D to +1.5 D in 0.5 D steps. In addition the following vergence values are measured: -0.25 D and +0.25 D. This examination is performed binocularly.
Time Frame
6 months (120-180 days) postoperative
Title
Binocular Contrast Sensitivity under photopic light conditions
Description
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
6 months (120-180 days) postoperative
Title
Binocular Contrast Sensitivity under mesopic light conditions
Description
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
6 months (120-180 days) postoperative
Title
Binocular Contrast Sensitivity under mesopic light conditions and using a glare source
Description
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
6 months (120-180 days) postoperative
Title
Halo and Glare Simulator
Description
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 such photic phenomena. This test is performed pre- and postoperatively. The preoperative outcomes deal as a baseline measurement.
Time Frame
preoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Title
Patient reported outcomes - Quality of Vision questionnaire [McAlinden et al, 2010]
Description
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].
Time Frame
preoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Title
Patient reported outcomes - Catquest-9SF 2011 questionnaire [Lundström et al, 2009]
Description
To assess if difficulties in daily life occur due to impaired sight. This questionnaire is 9-item Rasch-scaled instrument to assess subjective perception of visual impairment after surgery [Lundström et al, 2009].
Time Frame
preoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Title
Patient reported outcomes - Patient-Reported Spectacle Independence Questionnaire (PRSIQ) [Morlock et al, 2017]
Description
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].
Time Frame
preoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Title
Aberrometry
Description
Aberrometry outcomes are measured with a standard aberrometer. The following values will be evaluated in this study: Spherical aberrations, high order aberrations, lens tilt.
Time Frame
preoperative, 6 months (120-180 days) postoperative
Title
Pupil Size under photopic light conditions
Description
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). The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
Time Frame
preoperative, 6 months (120-180 days) postoperative
Title
Pupil Size under mesopic light conditions
Description
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). The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
Time Frame
preoperative, 6 months (120-180 days) postoperative
Title
Fundus examination with dilated pupil
Description
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
preoperative, 12 months (330-420 days) postoperative
Title
Slitlamp examination - Corneal status
Description
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
Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Title
Slitlamp examination - Signs of inflammation
Description
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
Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Title
Slitlamp examination - Pupillary block
Description
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
Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Title
Slitlamp examination - Retinal detachment
Description
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
Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Title
Slitlamp examination - Status of anterior and posterior capsule
Description
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
Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Title
Slitlamp examination - IOL decentration
Description
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
Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Title
Slitlamp examination - IOL tilt
Description
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
Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Title
Slitlamp examination - IOL discoloration
Description
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
Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Title
Slitlamp examination - IOL opacity
Description
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
Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Other Pre-specified Outcome Measures:
Title
Intraocular pressure (IOP) measurement
Description
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.
Time Frame
Preoperative, 1 day (1-2 days) postoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Title
Keratometry
Description
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.
Time Frame
Preoperative
Title
IOL power and target refraction
Description
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.
Time Frame
Operative (day of surgery)
Title
Fundus OCT
Description
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.
Time Frame
Preoperative, 1 month (30-60 days) postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Cataractous eyes with no comorbidity; Calculated IOL power is within the range of the study IOLs; Male or female adults ages 45 years or older on the day of screening who have cataract(s) in one or both eyes; Regular corneal astigmatism ≤1.0 D (measured by an automatic keratometer) Clear intraocular media other than cataract; Availability, willingness and sufficient cognitive awareness to comply with examination procedures; Signed informed consent. Exclusion Criteria: Age of patient < 45 years; Regular corneal astigmatism >1.0 dioptres (measured by an automatic keratometer) Irregular astigmatism; Difficulty for cooperation (distance from their home, general health conditions); Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse; Subjects with AMD suspicious eyes as determined by OCT examination; Subjects who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema; Previous intraocular or corneal surgery; Traumatic cataract; History or presence of macular edema; Instability of keratometry or biometry measurements; Ocular hypertension or glaucoma; Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic / scotopic conditions); Expected complicated surgery; Significant dry eye.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florian Kretz, MD
Organizational Affiliation
Augentagesklinik Rheine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hanusch Krankenhaus
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Facility Name
Gemini Eye Clinic
City
Zlín
ZIP/Postal Code
76001
Country
Czechia
Facility Name
Augen-Zentrum-Nordwest
City
Ahaus
ZIP/Postal Code
48683
Country
Germany
Facility Name
Universitäts-Augenklinik Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Smile Eyes Augen + Laserzentrum
City
Leipzig
ZIP/Postal Code
04107
Country
Germany
Facility Name
Augentagesklinik Rheine
City
Rheine
ZIP/Postal Code
48429
Country
Germany
Facility Name
Institute of Eye Surgery - Clane
City
Kildare
ZIP/Postal Code
W91 W535
Country
Ireland
Facility Name
Institute of Eye Surgery
City
Waterford
ZIP/Postal Code
X91 DH9W
Country
Ireland
Facility Name
Asian Eye Institute
City
Makati City
ZIP/Postal Code
1200
Country
Philippines
Facility Name
Oftalvist Alicante
City
Alicante
ZIP/Postal Code
03016
Country
Spain
Facility Name
Miranza IOA Madrid
City
Madrid
ZIP/Postal Code
28003
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20505205
Citation
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.
Results Reference
background
PubMed Identifier
28341605
Citation
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.
Results Reference
background
PubMed Identifier
19251145
Citation
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.
Results Reference
background

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PMCF Study on EDOF (Isopure) vs Monofocal (Micropure) IOL

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