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

NCT04249492 | Completed

• 1 other identifier: PHY2001
• Study Type: interventional
• Target: 250
• Locations: 6 countries
• Sites: 12

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.

Conditions

Cataract; Lens Opacities

Keywords

Intraocular Lens; EDOF; hydrophobic; IOL; monofocal

Outcome Measures

Primary Outcomes (1)

• monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions on the first implanted eye.

  No statistically significant difference between the two study groups on monocular CDVA at 4-6 months follow up visit. A significance level of 0.05 or lower (p \< 0.05) will be considered statistically significant. CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018.

  6 months (120-180 days) postoperative

Secondary Outcomes (39)

• Manifested refraction

  Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative

• Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions

  Preoperative, 1 day (1-2 days) postoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative

• Binocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions

  6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative

• Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions

  Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative

• Binocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions

  6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative

Other Outcomes (4)

• Intraocular pressure (IOP) measurement

  Preoperative, 1 day (1-2 days) postoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative

• Keratometry

  Preoperative

• IOL power and target refraction

  Operative (day of surgery)

Study Arms (2)

IOL implantation experimental

EXPERIMENTAL

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

Device: IOL implantation experimental (Isopure 1.2.3.)

IOL implantation active comparator

ACTIVE COMPARATOR

Comparator arm: Monofocal intraocular lens.

Device: IOL implantation active comparator (Micropure 1.2.3.)

Interventions

IOL implantation experimental (Isopure 1.2.3.) DEVICE

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

IOL implantation experimental

IOL implantation active comparator (Micropure 1.2.3.) DEVICE

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

IOL implantation active comparator

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beaver-Visitec International, Inc.: lead
• targomedGmbH: collaborator

Study Sites (12)

Hanusch Krankenhaus

Vienna, 1140, Austria

Location

Gemini Eye Clinic

Zlín, 76001, Czechia

Location

Augen-Zentrum-Nordwest

Ahaus, 48683, Germany

Location

Universitäts-Augenklinik Heidelberg

Heidelberg, 69120, Germany

Location

Smile Eyes Augen + Laserzentrum

Leipzig, 04107, Germany

Location

Augentagesklinik Rheine

Rheine, 48429, Germany

Location

Institute of Eye Surgery - Clane

Kildare, W91 W535, Ireland

Location

Institute of Eye Surgery

Waterford, X91 DH9W, Ireland

Location

Asian Eye Institute

Makati City, 1200, Philippines

Location

Oftalvist Alicante

Alicante, 03016, Spain

Location

Miranza IOA Madrid

Madrid, 28003, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Related Publications (3)

• 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.

  PMID: 20505205 BACKGROUND

• 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.

  PMID: 28341605 BACKGROUND

• 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.

  PMID: 19251145 BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Florian Kretz, MD

  Augentagesklinik Rheine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blind masking; Patient will not be informed which IOL model was implanted until end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: January 31, 2020
• Study Start: February 11, 2020
• Primary Completion: February 23, 2023
• Study Completion: April 18, 2024
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); PH (1); ES (3); AU (1); IE (2); DE (4)