PMCF Study on EDOF (Isopure) vs Monofocal (Micropure) IOL

NCT ID: NCT04249492

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-11
• Study Completion Date: 2024-04-18

Brief Summary

Multicenter, prospective, randomised, controlled, single-blind post-market clinical follow-up (PMCF) study to compare the clinical outcomes of an enhanced depth of focus (EDOF) IOL with the outcomes obtained with a monofocal lens. Implantation of the IOLs is bilaterally.

Detailed Description

This is a multicenter, prospective, randomised, controlled, single-blind post-market clinical follow-up (PMCF) study whereby patients undergoing routine cataract surgery will have bilateral implantation of Enhanced Depth of Focus intraocular lenses (Isopure 1.2.3.) or monofocal lenses (Micropure 1.2.3.). 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 study will be carried out in up to five clinical centers in Europe and Asia.

The device under investigation (Isopure 1.2.3.) is a hydrophobic, glistening-free, acrylic EDOF intraocular lens (IOL) manufactured by the sponsor of this study, PhysIOL sa/nv. The control lens is the parent IOL, belonging to the same IOL family of this manufacturer. It is a hydrophobic, glistening-free, acrylic monofocal IOL (Micropure 1.2.3.). 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 maximum 11 study visits (1 preoperative, 1 or 2 operative and up to 8 postoperative) over a period of 12 months. If local requirements allow, preoperative and operative visit can be done on the same day. Subjects would have the option for unscheduled visits if required medically.

Primary endpoint data will be collected at the 120-180 days follow up visit. Secondary endpoint data will be collected at the 330-420 days follow up visit. Data interim analyses will be done after the last patient finished the 120-180 days postoperative examination to support the study publication plan.

Conditions

Cataract; Lens Opacities

Study Design

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

Study Groups

IOL implantation experimental

Experimental arm: Enhanced depth of focus (EDOF) intraocular lens.

Group Type: EXPERIMENTAL

IOL implantation experimental (Isopure 1.2.3.)

Intervention Type: DEVICE

Implantation of trifocal IOL POD F GF consisting of light distribution order: far \> intermediate \> near

IOL implantation active comparator

Comparator arm: Monofocal intraocular lens.

Group Type: ACTIVE_COMPARATOR

IOL implantation active comparator (Micropure 1.2.3.)

Intervention Type: DEVICE

Implantation of trifocal IOL POD F GF consisting of light distribution order: far \> near \> intermediate

Interventions

IOL implantation experimental (Isopure 1.2.3.)

Implantation of trifocal IOL POD F GF consisting of light distribution order: far \> intermediate \> near

Intervention Type: DEVICE

IOL implantation active comparator (Micropure 1.2.3.)

Implantation of trifocal IOL POD F GF consisting of light distribution order: far \> near \> intermediate

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 45 years or older on the day of screening who have cataract(s) in one or both eyes;
• Regular corneal astigmatism ≤1.0 D (measured by an automatic keratometer)
• Clear intraocular media other than cataract;
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures;
• Signed informed consent.

Exclusion Criteria

• Age of patient < 45 years;
• Regular corneal astigmatism >1.0 dioptres (measured by an automatic keratometer)
• 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) that are predicted to cause future acuity losses to a level of 20/30 or worse;
• Subjects with AMD suspicious eyes as determined by OCT examination;
• 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;
• Previous intraocular or corneal surgery;
• Traumatic cataract;
• History or presence of macular edema;
• Instability of keratometry or biometry measurements;
• Ocular hypertension or glaucoma;
• Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic / scotopic conditions);
• Expected complicated surgery;
• Significant dry eye.

• Minimum Eligible Age: 45 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

Florian Kretz, MD

Role: PRINCIPAL_INVESTIGATOR

Augentagesklinik Rheine

Locations

Hanusch Krankenhaus

Vienna, , Austria

Gemini Eye Clinic

Zlín, , Czechia

Augen-Zentrum-Nordwest

Ahaus, , Germany

Universitäts-Augenklinik Heidelberg

Heidelberg, , Germany

Smile Eyes Augen + Laserzentrum

Leipzig, , Germany

Augentagesklinik Rheine

Rheine, , Germany

Institute of Eye Surgery - Clane

Kildare, , Ireland

Institute of Eye Surgery

Waterford, , Ireland

Asian Eye Institute

Makati City, , Philippines

Oftalvist Alicante

Alicante, , Spain

Miranza IOA Madrid

Madrid, , Spain

Hospital Clínico San Carlos

Madrid, , Spain

Countries

Austria; Czechia; Germany; Ireland; Philippines; Spain

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)

Lundstrom M, Pesudovs K. Catquest-9SF patient outcomes questionnaire: nine-item short-form Rasch-scaled revision of the Catquest questionnaire. J Cataract Refract Surg. 2009 Mar;35(3):504-13. doi: 10.1016/j.jcrs.2008.11.038.

Reference Type: BACKGROUND

PMID: 19251145 (View on PubMed)

Other Identifiers

PHY2001

Identifier Type: -

Identifier Source: org_study_id