Visual Performance, Patient Satisfaction and PCO Rate After Implantation of a Trifocal Hydrophobic IOL

Beaver-Visitec International, Inc.25 enrolled

Overview

Prospective, controlled, single-surgeon, single-center post-market clinical follow up study to investigate the clinical outcomes of a hydrophobic trifocal IOL (PhysIOL POD F GF)

This clinical investigation is a prospective, controlled, single-surgeon, single-center post-market clinical follow up study whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses FineVision POD F GF (PhysIOL, Liège, Belgium). The study purpose is to obtain clinical data on visual acuity, contrast sensitivity, questionnaire outcomes and PCO rate on patients implanted with FineVision POD F GF. The device under investigation (FineVision POD F GF) is a trifocal glistening-free hydrophobic acrylic intraocular lens (IOL) manufactured by the sponsor of this study PhysIOL sa/nv. The IOL will be implanted as part of the routine cataract surgery on patients suffering from cataract development. In total 25 patients will be recruited for this clinical study and receive a bilateral implantation of FineVision POD F GF intraocular lens. Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 24 months.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cataract Lens Opacities Presbyopia

Interventions

IOL implantation experimentalDEVICE

Implantation of trifocal IOL POD F GF consisting of hydrophobic material

Eligibility

Sex: ALLMin age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Cataractous eyes with no comorbidity * Spontaneously emitting the desire for spectacle independence after surgery and with realistic expectation. * Availability, willingness and sufficient cognitive awareness to comply with examination procedures * Signed informed consent Exclusion Criteria: * Irregular astigmatism * Age of patient \< 45 years * 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° in one or both eyes * Difficulty for cooperation (distance from their home, general health condition) * Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…) * Any ocular comorbidity * History of ocular trauma or prior ocular surgery including refractive procedures * Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome) * Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions) * AMD suspicious eyes (determined by OCT) * Complicated surgery

Locations (1)

Département d'ophtalmologie - CHU Morvan Bâtiment 4 bis

Brest, France

Outcomes

Primary Outcomes

binocular Uncorrected Distance Visual Acuity (UDVA)

Statistically significant equality between literature data and data obtained in this study on binocular UDVA. UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014