Clinical Outcomes of MICROPURE and PodEye Monofocal Intraocular Lenses (PHY1803)

Beaver-Visitec

Status: Completed

Conditions: Cataract; Lens Opacities

Treatments: Device: PODEYE; Device: Micropure 1.2.3.

Study type: Interventional

Funder types: Industry

Identifiers

NCT03796624

PHY1803

Details and patient eligibility

About

Prospective, non-randomised, open, controlled, single-center post-market clinical follow study about Micropure 1.2.3. and PODEYE intraocular lenses.

Full description

This clinical investigation is a prospective, non-randomised, open, controlled, single-center post-market clinical follow whereby study patients undergoing routine cataract surgery will have implantation of monofocal intraocular lens Micropure 1.2.3. (PhysIOL, Liège, Belgium) in one eye and implantation of monofocal intraocular lens PODEYE (PhysIOL, Liège, Belgium) in the contralateral eye of the same patient.

The study purpose is to obtain clinical data on visual acuity and contrast sensitivity on patients implanted with Micropure 1.2.3. and PODEYE

The devices under investigation (Micropure 1.2.3. and PODEYE) are a monofocal glistening-free hydrophobic acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv. The optical properties of the lenses are very comparable. The main difference is the mechanical design of the haptics, that is not expected to have an influence on the clinical outcomes.

The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.

In total 76 patients will be recruited for this clinical study and receive the implantation of Micropure 1.2.3. and POPDEYE intraocular lenses.

Subjects participating in the trial will attend study visits over a period of 12 months.

Enrollment: 76 patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Cataractous eyes with no comorbidity
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures
• Clear intraocular media other than cataract;
• Signed informed consent

Exclusion criteria

• Age of patient < 45 years;
• Irregular astigmatism;
• Regular corneal astigmatism >0.75 dioptres by an automatic keratometer or biometer or >1.0 dioptres if the steep axis of cylinder is between 90° and 120°;
• Difficulty for cooperation (distance from their home, general health condition);
• Previous intraocular or corneal surgery;
• Traumatic cataract;
• Any ocular comorbidity;
• Instability of keratometry or biometry measurements.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Investigational Device Micropure 1.2.3.

Experimental group

Description:

Implantation of monofocal intraocular lens (IOL) "Micropure 1.2.3." in one of the eyes of the study subject

Treatment:

Device: Micropure 1.2.3.

Comparator PODEYE

Active Comparator group

Description:

Implantation of monofocal intraocular lens (IOL) "PODEYE" in the contralateral eye of the study subject

Treatment:

Device: PODEYE