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AzTrials

CataractPHY2301NCT05875922

Comparison of ISOPURE and EYHANCE (Switzerland)

A study testing IOL implantation experimental (ISOPURE 1.2.3.) and IOL implantation active comparator (TECNIS Eyhance) in people with Cataract and Lens Opacities, run by Beaver-Visitec International, Inc. at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Cataract, Lens Opacities
What is being tested?
IOL implantation experimental (ISOPURE 1.2.3.) and IOL implantation active comparator (TECNIS Eyhance)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteSwitzerland
Study dates
31 Aug 2023to 12 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 24Show fewer
  • 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.
  • In addition to above mentioned in- and exclusion criteria, subjects shall be discontinued when certain conditions are present at the time of surgery, including:
  • 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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Eye center Vista Alpina

    Visp, 3930

Other trials in Switzerland

About this study

Official title: Prospective Post-Market Clinical Follow-Up (PMCF) Study to Investigate the Clinical Outcomes of a ISOPURE and EYHANCE Intraocular Lenses (IOL)

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.

Read the 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.

Being tested
IOL implantation experimental (ISOPURE 1.2.3.), IOL implantation active comparator (TECNIS Eyhance)
Keywords
Intraocular Lens, EDOF, hydrophobic, IOL
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IOL implantation experimental (ISOPURE 1.2.3.)Device

    Implantation of premium monofocal IOL ISOPURE 1.2.3.

  • IOL implantation active comparator (TECNIS Eyhance)Device

    Implantation of EDOF IOL TECNIS Eyhance

Study groups in NCT05875922
Study groupRoleWhat they receive
IOL implantation experimentalExperimentalExperimental arm: Premium monofocal intraocular lens.
Receives: Device: IOL implantation experimental (ISOPURE 1.2.3.)
IOL implantation active comparatorActive comparatorComparator arm: EDOF intraocular lens.
Receives: Device: IOL implantation active comparator (TECNIS Eyhance)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Non inferiority of ISOPURE 1.2.3. outcomes compared to the TECNIS Eyehance outcomes in terms of monocular Best Corrected Distance Visual Acuity (CDVA) by means of statistical significance.

    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.

    Measured: 6 months (120-180 days) postoperative

Secondary outcomes (1)

  1. Safety (Rates of Adverse Events)

    The objective is to compare the SPE (Safety and Performance Endpoints) rates of the investigational product to the results of historical data of EN ISO 11979-7:2018, Annex E (Table E.2)

    Measured: 1 day (1-2 days) postoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2023
  2. Study start31 Aug 2023
  3. Primary completion12 Mar 2025
  4. Study completion12 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05875922
Sponsor's protocol ID
PHY2301
Acronym
PHY2301
Status last verified
Mar 2025
First submitted
5 May 2023
Last updated
18 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28341605

  • 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.

    PubMed 37007049

  • 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.

    PubMed 32932369

  • 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.

    PubMed 35947003

Questions about this trial

What is this clinical trial studying?

A study testing IOL implantation experimental (ISOPURE 1.2.3.) and IOL implantation active comparator (TECNIS Eyhance) in people with Cataract and Lens Opacities, run by Beaver-Visitec International, Inc. at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions on the first implanted eye. (time frame: 6 months (120-180 days) postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05875922, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.

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