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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

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

Who can participate

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

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 informed consent 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
04

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

05

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

06

Study locations

1 of 1 sites recruiting
  • Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna
    Vienna, 1140, Austria
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

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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