PMCF Study on Comparison of EDOF Lenses (Switzerland)

NCT ID: NCT05235139

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-09
• Study Completion Date: 2023-08-22

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.

Conditions

Cataract; Lens Opacities

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

IOL implantation experimental

Experimental arm: Premium monofocal intraocular lens.

Group Type: EXPERIMENTAL

IOL implantation experimental (ISOPURE 1.2.3.)

Intervention Type: DEVICE

Implantation of premium monofocal IOL ISOPURE 1.2.3.

IOL implantation active comparator

Comparator arm: EDOF intraocular lens.

Group Type: ACTIVE_COMPARATOR

IOL implantation active comparator (Acrysof Vivity)

Intervention Type: DEVICE

Implantation of EDOF IOL Acrysof Vivity

Interventions

IOL implantation experimental (ISOPURE 1.2.3.)

Implantation of premium monofocal IOL ISOPURE 1.2.3.

Intervention Type: DEVICE

IOL implantation active comparator (Acrysof Vivity)

Implantation of EDOF IOL Acrysof Vivity

Intervention Type: DEVICE

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.

• 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

targomedGmbH

INDUSTRY

Sponsor Role: collaborator

Beaver-Visitec International, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristof Vandekerkchove, MD

Role: PRINCIPAL_INVESTIGATOR

Eye center Vista Alpina

Locations

Eye center Vista Alpina

Visp, , Switzerland

Countries

Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 20505205 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28341605 (View on PubMed)

Other Identifiers

PHY2130

Identifier Type: -

Identifier Source: org_study_id