ClinicalTrials.gg
RecruitingNCT06345820Updated Apr 4, 2024

Comparison of Two Non-diffractive Enhanced Monofocal Intraocular Lenses

An interventional study of Evolux and Tecnis Eyhance in Cataract, sponsored by Vienna Institute for Research in Ocular Surgery. Recruiting at 1 site in Austria. Open to participants aged 21 Years to 105 Years. Per ClinicalTrials.gov, last updated 2024-04-04.

Sponsored by Vienna Institute for Research in Ocular Surgery · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Registered 9 months after the study started (first participant enrolled Jun 2023, registered Mar 2024).
  • Started Jun 2023; still recruiting 3 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
21 Years to 105 Years
Sex
All
01

Study summary

Comparison of the clinical performance of two enhanced monofocal IOLs with similar design.

Read the detailed description

In modern cataract surgery the aim of the procedure is not just the restoration of vision but to also achieve some spectacle independence. Bilateral implantation of monofocal intraocular lenses (IOL) aiming for emmetropia lead to high patient satisfaction levels in distance vision but leave patients dependent on spectacles in intermediate and near vision tasks.

To achieve high levels of spectacle independence the most commonly used option are multifocal intraocular lenses (MIOL). These MIOLs use either a refractive or diffractive optical design, a combination of both or segmented asymmetric optics. Usually, the characteristic diffractive ring patterns are incorporated on the posterior surface of an IOL, whereas the anterior lens surface remains purely refractive. However, a portion of patients experience problems with positive dysphotopsia symptoms such as halos and glare. Other potentially negative aspects of MIOLs are pupil size dependency and loss of light energy to higher order diffraction which can lead to reduced contrast sensitivity. In clinical studies diffractive lenses resulted in a better outcome in terms of optical quality, better contrast sensitivity and positive dysphotopsia phenomena than refractive multifocal lenses.

A newer concept of IOLs are non-diffractive enhanced range of vision (EROV) IOLs, sometimes also referred to as EDOF IOLs. The EROV IOLs with the least compromise concerning quality of vision are the group of so called enhanced monofocal IOL, also sometime referred to as monofocal plus IOL. These IOLs should result in better intermediate vison and provide contrast sensitivity and dysphotopsia results comparable to standard monofocal IOLs. These IOLs may be more adequate to meet the expectations of many presbyopic cataract patients, who were used to have a good distance vision and who were wearing spectacles when performing near vision tasks before surgery.

The aim of this study is to compare the clinical performance of a newer enhanced monofocal IOL (Evolux) with a standard enhanced monofocal IOL, the Tecnis Eyhance.

02

Conditions studied

  • Cataract

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Keywords

  • Cataract
  • Cataract surgery
  • Intraocular lens
03

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's planned enrollment of 35 is below the median of 79 across 1,092 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Vienna Institute for Research in Ocular Surgery is the lead sponsor of 65 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 105 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Bilateral cataract
  • Age 21 or older
  • Visual acuity > 0.05
  • Axial length: 22.00-26.00mm
  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
  • Written prior to surgery
  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures

Exclusion criteria

Exclusion Criteria:

  • Active ocular disease (e.g. chronic uveitis, proliferative diabetic retinopathy, chronic glaucoma not responsive to medication)
  • Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX), Intraoperative Floppy Iris Syndrome (IFIS)
  • Corneal decompensation or corneal endothelial cell insufficiency
  • Amblyopia
  • Previous ocular surgery or trauma
  • Persons who are pregnant or nursing (pregnancy test will be taken in women of reproductive age)
  • Astigmatism with the need for a toric IOL
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
35 participants (estimated)

Study arms

  • Experimental
    Evolux

    Patient will receive the Enova IOL during cataract surgery

    Device: Evolux

  • Experimental
    Tecnis Eyhance

    Patient will receive the Tecnis Ehance IOL during cataract surgery

    Device: Tecnis Eyhance

Interventions

  • DeviceEvolux

    Evolux, enhanced monofocal IOL

  • DeviceTecnis Eyhance

    Tecnis Eyhance, enhanced monofocal IOL

06

What researchers measure

Primary outcomes

  1. Monocular intermediate visual acuity

    Monocular intermediate visual acuity at 66 cm will be measured using ETDRS charts

    Time frame: 24 months

Secondary outcomes

  1. Monocular distance visual acuity

    Monocular distance visual acuity at 4 meters will be measured using ETDRS charts

    Time frame: 24 months

  2. Monocular near visual acuity

    Monocular near visual acuity at 40 cm will be measured using ETDRS charts

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2023 (actual). Primary completion is estimated for Jun 2025, 24 months after the start.

Of 300 non-industry interventional studies with no phase under Cataract, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 24 months is above that.

Counting every sponsor, half of 490 studies reached it within 17 months; a quarter within 9 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 28, 2024
First posted
Apr 3, 2024
StartActual
Jun 28, 2023
Primary completionEst.
Jun 2025
CompletionEst.
Jun 2025
Last update
Apr 4, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06345820
Lead sponsor
Vienna Institute for Research in Ocular Surgery
Responsible party
Prim. Prof. Dr. Oliver Findl, MBA (Principal Investigator, Vienna Institute for Research in Ocular Surgery) — Principal investigator
First posted
Apr 3, 2024
Start date
Jun 28, 2023
Primary completion
Jun 2025 (estimated)
Completion
Jun 2025 (estimated)
Last update
Apr 4, 2024

Study contacts

Andreas Rotter, MD
Contact
office@viros.at
01 91021 ext. 57564
Manuel Ruiss, MSc
Contact
office@viros.at
01 91021 ext. 57564
Oliver Findl, Prim. Dr.
principal investigator · Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Krankenhaus

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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