PMCF Study on Comparison of EDOF Lenses (Switzerland)

Cataract Clinical Trial

— PHY2130  

Official title:

Prospective Post-Market Clinical Follow-Up (PMCF) Study to Investigate the Clinical Outcomes of a Premium Monofocal Intraocular Lens (IOL) in Comparison to an EDOF Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05235139
• Other study ID #: PHY2130
• Status: Completed
• Phase: N/A
• Start date: March 9, 2022
• Est. completion date: August 22, 2023

Study information

• Verified date: May 2024
• Source: Beaver-Visitec International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Single center, prospective, randomised, controlled, double-blind post-market clinical follow-up (PMCF) study to compare the clinical outcomes of a premium monofocal intraocular lens (PhysIOL ISOPURE 1.2.3.) with clinical data obtained in a control group implanted with an EDOF IOL (Alcon Acrysof IQ Vivity).

Description:

This is a single center, prospective, randomised, controlled, double-blind post-market clinical follow-up (PMCF) study whereby patients undergoing routine cataract surgery will have bilateral implantation of premium monofocal intraocular lenses (PhysIOL ISOPURE 1.2.3.) or EDOF lenses (Alcon Acrysof IQ Vivity). 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 device under investigation (ISOPURE 1.2.3.) is a hydrophobic, glistening-free, acrylic premium monofocal intraocular lens (IOL) manufactured by the sponsor of this study, PhysIOL sa/nv. The control lens (Alcon Acrysof IQ Vivity) is a non-diffractive Extended Vision Posterior Chamber IOL.

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 6 study visits (1 preoperative, 1 operative and 4 postoperative) over a period of 6 months. Subjects would have the option for unscheduled visits if required medically.

Primary and secondary endpoint data will be collected at the 120-180 days follow up visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: August 22, 2023
• Est. primary completion date: August 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Cataractous eyes with no comorbidity;

• Calculated IOL power is within the range of the study IOLs;

• Male or female adults ages 50 years or older on the day of screening who have cataract(s) in one or both eyes;

• Regular total corneal astigmatism =1.0 D (measured by topography method)

• Clear intraocular media other than cataract;

• Availability, willingness and sufficient cognitive awareness to comply with examination procedures;

• Expected postoperative Best Corrected Distance Visual Acuity (CDVA) = 0.2 logMAR;

• Signed informed consent.

Exclusion Criteria:

• Age of patient < 50 years;

• Regular total corneal astigmatism >1.0 dioptres (measured by topography method)

• 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);

• 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 or macula pucker;

• Previous intraocular or corneal surgery or intravitreal injection;

• Traumatic cataract;

• History or presence of macular edema;

• Glaucoma with visual field defects;

• Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic / scotopic conditions);

• Amblyopia with monocular preoperative CDVA of >0.1 logMAR;

• Cornea guttata;

• Keratoconus;

• Chronic uveitis;

• Expected complicated surgery;

• Significant dry eye;

• Contra-indications as listed in the current Instructions for use (IFU);

• Contra-indication or unwillingness to perform immediate sequential bilateral cataract surgery;

• Concurrent or previous (within 60 days) participation in another drug or device investigation.

In addition to above mentioned in- and exclusion criteria, subjects shall be discontinued when certain conditions are present at the time of surgery, including:

• zonular instability or defect;

• capsular fibrosis or other opacity; and

• inability to fixate IOL in desired position. In such cases, the subject shall be followed until the condition has stabilized.

Related Conditions & MeSH terms

• Cataract
• Lens Opacities

Intervention

Device:
• IOL implantation experimental (ISOPURE 1.2.3.)
Implantation of premium monofocal IOL ISOPURE 1.2.3.
• IOL implantation active comparator (Acrysof Vivity)
Implantation of EDOF IOL Acrysof Vivity

Locations

Country	Name	City	State
Switzerland	Eye center Vista Alpina	Visp

Sponsors (2)

Lead Sponsor	Collaborator
Beaver-Visitec International, Inc.	targomedGmbH

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intraocular pressure (IOP) measurement	The IOP will be measured with non-contact tonometer as part of the routine follow up examinations. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.	Preoperative, 1 day (1-2 days) postoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Other	Keratometry	Keratometric measurements are performed to calculate the required IOL power. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.	Preoperative
Other	IOL power	The IOL spherical power of the implanted IOL must be recorded.	Operative (day of surgery)
Other	Target refraction	The target refraction given by the IOL calculator must be recorded. 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.	Operative (day of surgery)
Other	Fundus OCT	An OCT (optical coherence tomography) image will be taken at the preoperative visit and 1 months postoperative visit to identify AMD suspicious eyes that need to be excluded from this study. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.	Preoperative, 1 month (30-60 days) postoperative
Other	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.	preoperative
Other	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.	preoperative
Other	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)	Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Other	Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions	monocular UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.	Preoperative, 1 day (1-2 days) postoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Other	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.	1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Other	Binocular Uncorrected Distance Visual Acuity (UDVA) under mesopic 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 mesopic light conditions.	1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Other	Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions	Monocular CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.	Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Other	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.	6 months (120-180 days) postoperative
Other	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.	1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Other	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.	1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Other	Binocular Uncorrected Intermediate Visual Acuity at 66cm (UIVA@66cm) under mesopic 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 mesopic light conditions.	1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Other	Monocular Distance Corrected Near Visual Acuity at 40cm (DCNVA) under photopic light conditions	Monocular DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.	1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Other	Binocular Uncorrected Near Visual Acuity at 40cm (UNVA) under photopic light conditions	Monocular UNVA is measured with ETDRS charts placed in 40cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.	1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Other	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. This examination is performed binocularly.	1 month (30-60 days) postoperative
Other	Binocular Contrast Sensitivity under photopic light conditions	Contrast Sensitivity under photopic light conditions using the standardized contrast sensitivity device CSV-1000 (Vector Vision). This examination is performed binocularly.	6 months (120-180 days) postoperative
Other	Binocular Contrast Sensitivity under mesopic light conditions	Contrast Sensitivity under mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (Vector Vision). This examination is performed binocularly.	6 months (120-180 days) postoperative
Other	Slitlamp examination - Corneal status	The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.; With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Corneal Status	Preoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Other	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	Preoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Other	Slitlamp examination - Iris status	The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.; With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: - Iris status	Preoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Other	Fundus examination with dilated pupil	The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.; With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Fundus	Preoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Other	Slitlamp examination - Optic nerve cupping	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: - Optic nerve cupping	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	Slitlamp examination - Posterior Capsular Opacification (PCO) or Posterior Capsular Fibrosis	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: - Posterior Capsular Opacification (PCO) or Posterior Capsular Fibrosis	1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Other	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.	6 months (120-180 days) postoperative
Other	Slitlamp examination - abnormal IOL positioning	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: - abnormal IOL positioning	1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Other	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].	6 months (120-180 days) postoperative
Other	Patient reported outcomes - Patient-Reported Spectacle Independence Questionnaire (PRSIQ) [Morlock et al, 2017]	The Patient-Reported Spectacle Independence Questionnaire (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].; In the first category, subjects are asked if they need glasses for distance vision, intermediate vision and near vision with 'yes' and 'no' being the only possible answers.; In the second category, patients are asked to scale their frequency of using spectacles over the last 7 days for three different distances with 5 ratings ranging from '1: All of the time' to '5: None of the time'. A higher rating means higher rate of spectacle independence.; In addition, patients are asked to scale if they are able to function without spectacle aid for three different distances with 5 ratings ranging from '1: All of the time' to '5: None of the time'. A higher rating means higher rate of spectacle freedom.	6 months (120-180 days) postoperative
Primary	monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions on the first implanted eye.	Non inferiority of ISOPURE 1.2.3. outcomes compared to the Acrysof IQ Vivity outcomes in terms of monocular Best Corrected Distance Visual Acuity (CDVA) by means of statistical significance.; 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.	6 months (120-180 days) postoperative
Secondary	Safety (Rates of Adverse Events)	The objective is to compare the SPE (Safety and Performance Endpoints) rates of the investigational product to the results of historical data of EN ISO 11979-7:2018, Annex E (Table E.2)	1 day (1-2 days) postoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative