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

Beaver-Visitec

Status: Active, not recruiting

Conditions: Cataract; Lens Opacities

Treatments: Device: IOL implantation active comparator (Micropure 1.2.3.); Device: IOL implantation experimental (Isopure 1.2.3.)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04249492

PHY2001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 244 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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244 participants in 2 patient groups

IOL implantation experimental

Experimental group

Description:

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

Treatment:

Device: IOL implantation experimental (Isopure 1.2.3.)

IOL implantation active comparator

Active Comparator group

Description:

Comparator arm: Monofocal intraocular lens.

Treatment:

Device: IOL implantation active comparator (Micropure 1.2.3.)