Clinical Study to Compare Visual Performance of Two Trifocal IOLs

Beaver-Visitec International, Inc.53 enrolled

Overview

Prospective, randomised, controlled, single-surgeon, single-center post-market clinical follow up study to compare the clinical outcomes of two trifocal IOLs with different material

This is a prospective, randomised, 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. The patients will either be implanted with the hydrophobic IOL FineVision POD F GF or the hydrophilic IOL FineVision Pod F. The primary and secondary effectiveness data for visual acuity, contrast sensitivity, halometry, aberrometry, questionnaire outcomes and any adverse events will be collected. Subjects participating in the trial will attend a total of 10 study visits (1 preoperative, 2 operative and 7 postoperative) over a period of 3 months. Subjects would have the option for unscheduled visits if required medically. Primary endpoint data will be collected at the 3 months follow up visit. Data analyses will be done after the last patient finished the final examination to support the study publication plan.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

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

IOL implantation active comparatorDEVICE

Implantation of trifocal IOL POD F consisting of hydrophilic material

Eligibility

Sex: ALLMin age: 50 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 \< 50 years * Regular corneal astigmatism \>1.00 dioptres by an automatic keratometer or biometer or \>1.25 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)

Innova Ocular IOA Madrid

Madrid, Spain

Outcomes

Primary Outcomes

monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions.

The primary study end point is to show statistically equal visual acuity outcomes between both study groups. The primary study endpoint parameter is monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions. UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014