Comparison of ISOPURE and EYHANCE (Switzerland)

NCT ID: NCT05875922

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2025-03-12

Brief Summary

This is a prospective randomised open-label study with the aim to compare the visual performance of the premium monofocal Isopure IOL versus the extended depth of focus Eyhance® IOL after phaco-emulsification cataract surgery.

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 (TECNIS Eyhance). 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 (TECNIS Eyhance) 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 (TECNIS Eyhance)

Intervention Type: DEVICE

Implantation of EDOF IOL TECNIS Eyhance

Interventions

IOL implantation experimental (ISOPURE 1.2.3.)

Implantation of premium monofocal IOL ISOPURE 1.2.3.

Intervention Type: DEVICE

IOL implantation active comparator (TECNIS Eyhance)

Implantation of EDOF IOL TECNIS Eyhance

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 laser treatment for peripheral retinal tears is allowed;
• Previous intraocular or corneal surgery or intravitreal injection;
• Traumatic cataract;
• History or presence of macular edema;
• Glaucoma with visual field defects; or RNFL defects on OCT; ocular hypertension is allowed;
• 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

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)

Tomagova N, Elahi S, Vandekerckhove K. Clinical Outcomes of a New Non-Diffractive Extended Depth-of-Focus Intraocular Lens Targeted for Mini-Monovision. Clin Ophthalmol. 2023 Mar 25;17:981-990. doi: 10.2147/OPTH.S405267. eCollection 2023.

Reference Type: BACKGROUND

PMID: 37007049 (View on PubMed)

Auffarth GU, Gerl M, Tsai L, Janakiraman DP, Jackson B, Alarcon A, Dick HB; Quantum Study Group. Clinical evaluation of a new monofocal IOL with enhanced intermediate function in patients with cataract. J Cataract Refract Surg. 2021 Feb 1;47(2):184-191. doi: 10.1097/j.jcrs.0000000000000399.

Reference Type: BACKGROUND

PMID: 32932369 (View on PubMed)

Wan KH, Au ACK, Kua WN, Ng ALK, Cheng GPM, Lam NM, Chow VWS. Enhanced Monofocal Versus Conventional Monofocal Intraocular Lens in Cataract Surgery: A Meta-analysis. J Refract Surg. 2022 Aug;38(8):538-546. doi: 10.3928/1081597X-20220707-01. Epub 2022 Aug 1.

Reference Type: BACKGROUND

PMID: 35947003 (View on PubMed)

Other Identifiers

PHY2301

Identifier Type: -

Identifier Source: org_study_id