Clinical trial NCT05235139: PMCF Study on Comparison of EDOF Lenses (Switzerland)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lens Opacities
Keywords: Intraocular Lens
EDOF
hydrophobic
IOL
Lead sponsor: Beaver-Visitec International, Inc.
Sponsor class: INDUSTRY
Collaborators: name: targomedGmbH
First posted: 2022-02-11
Enrollment: 73
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

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 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.

Primary outcomes:
measure: monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions on the first implanted eye.
timeFrame: 6 months (120-180 days) postoperative
Secondary outcomes:
measure: Safety (Rates of Adverse Events)
timeFrame: 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 outcomes:
measure: Intraocular pressure (IOP) measurement
timeFrame: 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
measure: Keratometry
timeFrame: Preoperative
measure: IOL power
timeFrame: Operative (day of surgery)
measure: Target refraction
timeFrame: Operative (day of surgery)
measure: Fundus OCT
timeFrame: Preoperative, 1 month (30-60 days) postoperative
measure: Pupil Size under photopic light conditions
timeFrame: preoperative
measure: Pupil Size under mesopic light conditions
timeFrame: preoperative
measure: Manifested refraction
timeFrame: Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
measure: Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions
timeFrame: 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
measure: Binocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions
timeFrame: 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
measure: Binocular Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions
timeFrame: 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
measure: Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions
timeFrame: Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
measure: Binocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions
timeFrame: 6 months (120-180 days) postoperative
measure: Monocular Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA@66cm) under photopic light conditions
timeFrame: 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
measure: Binocular Uncorrected Intermediate Visual Acuity at 66cm (UIVA@66cm) under photopic light condition
timeFrame: 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
measure: Binocular Uncorrected Intermediate Visual Acuity at 66cm (UIVA@66cm) under mesopic light condition
timeFrame: 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
measure: Monocular Distance Corrected Near Visual Acuity at 40cm (DCNVA) under photopic light conditions
timeFrame: 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
measure: Binocular Uncorrected Near Visual Acuity at 40cm (UNVA) under photopic light conditions
timeFrame: 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
measure: Binocular Defocus Curve
timeFrame: 1 month (30-60 days) postoperative
measure: Binocular Contrast Sensitivity under photopic light conditions
timeFrame: 6 months (120-180 days) postoperative
measure: Binocular Contrast Sensitivity under mesopic light conditions
timeFrame: 6 months (120-180 days) postoperative
measure: Slitlamp examination - Corneal status
timeFrame: Preoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
measure: Slitlamp examination - Signs of inflammation
timeFrame: Preoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
measure: Slitlamp examination - Iris status
timeFrame: Preoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
measure: Fundus examination with dilated pupil
timeFrame: Preoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
measure: Slitlamp examination - Optic nerve cupping
timeFrame: 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
measure: Slitlamp examination - Posterior Capsular Opacification (PCO) or Posterior Capsular Fibrosis
timeFrame: 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
measure: Slitlamp examination - IOL discoloration
timeFrame: 6 months (120-180 days) postoperative
measure: Slitlamp examination - abnormal IOL positioning
timeFrame: 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
measure: Patient reported outcomes - Quality of Vision questionnaire [McAlinden et al, 2010]
timeFrame: 6 months (120-180 days) postoperative
measure: Patient reported outcomes - Patient-Reported Spectacle Independence Questionnaire (PRSIQ) [Morlock et al, 2017]
timeFrame: 6 months (120-180 days) postoperative
Locations:
city: Visp
country: Switzerland
facility: Eye center Vista Alpina
Study officials:
affiliation: Eye center Vista Alpina
name: Kristof Vandekerkchove, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.