CataractPHY2001NCT04249492
PMCF Study on EDOF (Isopure) vs Monofocal (Micropure) IOL
A study testing IOL implantation experimental (Isopure 1.2.3.) and IOL implantation active comparator (Micropure 1.2.3.) in people with Cataract and Lens Opacities, run by Beaver-Visitec International, Inc. at 12 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Lens Opacities
- What is being tested?
- IOL implantation experimental (Isopure 1.2.3.) and IOL implantation active comparator (Micropure 1.2.3.)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 12 sitesin 6 countries
- Study dates
- 11 Feb 2020to 18 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
12 sites in 6 countries.
12 sites in 6 countries
Germany4 sites
Augen-Zentrum-Nordwest
Ahaus, 48683
Universitäts-Augenklinik Heidelberg
Heidelberg, 69120
Smile Eyes Augen + Laserzentrum
Leipzig, 04107
Augentagesklinik Rheine
Rheine, 48429
Spain3 sites
Oftalvist Alicante
Alicante, 03016
Miranza IOA Madrid
Madrid, 28003
Hospital Clínico San Carlos
Madrid, 28040
Ireland2 sites
Institute of Eye Surgery - Clane
Kildare, W91 W535
Institute of Eye Surgery
Waterford, X91 DH9W
About this study
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
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.
Read the 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.
- Conditions
- Cataract, Lens Opacities
- Being tested
- IOL implantation experimental (Isopure 1.2.3.), IOL implantation active comparator (Micropure 1.2.3.)
- Keywords
- Intraocular Lens, EDOF, hydrophobic, IOL, monofocal
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOL implantation experimental (Isopure 1.2.3.)Device
Implantation of trifocal IOL POD F GF consisting of light distribution order: far > intermediate > near
IOL implantation active comparator (Micropure 1.2.3.)Device
Implantation of trifocal IOL POD F GF consisting of light distribution order: far > near > intermediate
| Study group | Role | What they receive |
|---|---|---|
| IOL implantation experimental | Experimental | Experimental arm: Enhanced depth of focus (EDOF) intraocular lens. Receives: Device: IOL implantation experimental (Isopure 1.2.3.) |
| IOL implantation active comparator | Active comparator | Comparator arm: Monofocal intraocular lens. Receives: Device: IOL implantation active comparator (Micropure 1.2.3.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months (120-180 days) postoperative
Secondary outcomes (39)
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)
Measured: 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
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.
Measured: 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
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.
Measured: 6 months (120-180 days) postoperative, 12 months (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.
Measured: 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
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.
Measured: 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
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).
Measured: 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
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.
Measured: 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
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.
Measured: 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
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.
Measured: 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
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.
Measured: 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
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).
Measured: 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
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.
Measured: 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
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.
Measured: 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
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.
Measured: 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
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.
Measured: 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
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).
Measured: 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
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.
Measured: 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
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.
Measured: 1 month (30-60 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 -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.
Measured: 6 months (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.
Measured: 6 months (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.
Measured: 6 months (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.
Measured: 6 months (120-180 days) postoperative
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.
Measured: preoperative, 6 months (120-180 days) postoperative, 12 months (330-420 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].
Measured: preoperative, 6 months (120-180 days) postoperative, 12 months (330-420 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 9-item Rasch-scaled instrument to assess subjective perception of visual impairment after surgery [Lundström et al, 2009].
Measured: preoperative, 6 months (120-180 days) postoperative, 12 months (330-420 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].
Measured: preoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
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.
Measured: preoperative, 6 months (120-180 days) postoperative
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.
Measured: preoperative, 6 months (120-180 days) postoperative
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.
Measured: preoperative, 6 months (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
Measured: preoperative, 12 months (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
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start11 Feb 2020
- Primary completion23 Feb 2023
- Study completion18 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaver-Visitec International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- targomedGmbH
- Responsible party
- Sponsor
- Investigators
- Florian Kretz, MD, Principal investigator, Augentagesklinik Rheine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249492
- Sponsor's protocol ID
- PHY2001
- Acronym
- PHY2001
- Status last verified
- Nov 2025
- First submitted
- 28 Jan 2020
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20505205Morlock 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.
PubMed 28341605Lundstrom 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.
PubMed 19251145
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04249492
- Acronym / sponsor ID
- PHY2001 / PHY2001
- Conditions
- Cataract, Lens Opacities
- Keywords
- Intraocular Lens, EDOF, hydrophobic, IOL, monofocal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Beaver-Visitec International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- targomedGmbH
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 18 Apr 2024 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IOL implantation experimental | Experimental | Device: IOL implantation experimental (Isopure 1.2.3.)Experimental arm: Enhanced depth of focus (EDOF) intraocular lens. |
| IOL implantation active comparator | Active comparator | Device: IOL implantation active comparator (Micropure 1.2.3.)Comparator arm: Monofocal intraocular lens. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IOL implantation experimental (Isopure 1.2.3.)Implantation of trifocal IOL POD F GF consisting of light distribution order: far > intermediate > near | Device | IOL implantation experimental |
| IOL implantation active comparator (Micropure 1.2.3.)Implantation of trifocal IOL POD F GF consisting of light distribution order: far > near > intermediate | Device | IOL implantation active comparator |
Primary outcome
monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions on the first implanted eye.
Time frame: 6 months (120-180 days) postoperative
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.
39 secondary outcomes
Manifested refraction
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
Monocular Uncorrected Distance Visual Acuity (UDVA) 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
Binocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions
Time frame: 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Monocular Corrected Distance Visual Acuity (CDVA) 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
Binocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions
Time frame: 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Monocular Corrected Distance Visual Acuity (low contrast CDVA) using low contrast (10%) optotypes under photopic light conditions
Time frame: 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Monocular Uncorrected Intermediate Visual Acuity at 80cm (UIVA@80cm) under photopic light condition
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
Binocular Uncorrected Intermediate Visual Acuity at 80cm (UIVA@80cm) under photopic light condition
Time frame: 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Monocular Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA@80cm) 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
Binocular Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA@80cm) under photopic light conditions
Time frame: 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Monocular Distance Corrected Distance Visual Acuity at 80cm (low contrast DCIVA@80cm) using low contrast (10%) optotypes under photopic light conditions
Time frame: 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Monocular Uncorrected Intermediate Visual Acuity at 66cm (UIVA@66cm) under photopic light condition
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
Binocular Uncorrected Intermediate Visual Acuity at 66cm (UIVA@66cm) under photopic light condition
Time frame: 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Monocular Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA@66cm) 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
Binocular Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA@66cm) under photopic light conditions
Time frame: 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Monocular Distance Corrected Distance Visual Acuity at 66cm (low contrast DCIVA@66cm) using low contrast (10%) optotypes under photopic light conditions
Time frame: 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Binocular Distance Corrected Near Visual Acuity at 40cm (DCNVA) under photopic light conditions
Time frame: 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Monocular Defocus Curve
Time frame: 1 month (30-60 days) postoperative
Binocular Defocus Curve
Time frame: 6 months (120-180 days) postoperative
Binocular Contrast Sensitivity under photopic light conditions
Time frame: 6 months (120-180 days) postoperative
Binocular Contrast Sensitivity under mesopic light conditions
Time frame: 6 months (120-180 days) postoperative
Binocular Contrast Sensitivity under mesopic light conditions and using a glare source
Time frame: 6 months (120-180 days) postoperative
Halo and Glare Simulator
Time frame: preoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Patient reported outcomes - Quality of Vision questionnaire [McAlinden et al, 2010]
Time frame: preoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Patient reported outcomes - Catquest-9SF 2011 questionnaire [Lundström et al, 2009]
Time frame: preoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Patient reported outcomes - Patient-Reported Spectacle Independence Questionnaire (PRSIQ) [Morlock et al, 2017]
Time frame: preoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Aberrometry
Time frame: preoperative, 6 months (120-180 days) postoperative
Pupil Size under photopic light conditions
Time frame: preoperative, 6 months (120-180 days) postoperative
Pupil Size under mesopic light conditions
Time frame: preoperative, 6 months (120-180 days) postoperative
Fundus examination with dilated pupil
Time frame: preoperative, 12 months (330-420 days) postoperative
Slitlamp examination - 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
Slitlamp examination - Signs of inflammation
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
Slitlamp examination - 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
Slitlamp examination - 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
Slitlamp examination - 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
Slitlamp examination - 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
Slitlamp examination - 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
Slitlamp examination - 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
Slitlamp examination - 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Background: PubMed 20505205McAlinden 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.
- Background: PubMed 28341605Morlock 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.
- Background: PubMed 19251145Lundstrom 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florian Kretz, MD principal investigator
Augentagesklinik Rheine
12 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IOL implantation experimental (Isopure 1.2.3.) and IOL implantation active comparator (Micropure 1.2.3.) in people with Cataract and Lens Opacities, run by Beaver-Visitec International, Inc. at 12 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, Spain, Ireland, Austria, Czechia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions on the first implanted eye. (time frame: 6 months (120-180 days) postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04249492, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.