CClinicalTrials.gg
Status unknownNCT03748381Updated Nov 23, 2018

Comparison of 2 Diffractive Trifocal IOLs

An interventional study of Cataract surgery in Cataract, sponsored by Prim. Prof. Dr. Oliver Findl, MBA. Status unknown at 1 site in Austria. Open to participants aged 21 Years to 105 Years. Per ClinicalTrials.gov, last updated 2018-11-23.

Sponsored by Prim. Prof. Dr. Oliver Findl, MBA · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Apr 2018, registered Nov 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Not applicable
Ages
21 Years to 105 Years
Sex
All
01

Study summary

Compare two commercially available bilateral implanted diffractive trifocal lenses (Zeiss AT Lisa tri vs. Rayner trifocal) after cataract surgery concerning visual function and spectacle independence.

Read the detailed description

Spectacle independence is a central aim in modern cataract surgery. Although bilateral monofocal IOL implantation, aiming for emmetropia or low myopia, leads to high levels of patient satisfaction in distance vision, spectacle dependence for reading and other near vision tasks is the usual result.

The option commonly used to achieve spectacle independence are multifocal intraocular lenses (IOLs). Multifocal IOLs either use a refractive or diffractive design or a combination of both or segmented asymmetric optics. The principal of the refractive design is based on changing the route of light rays by thickness, curvature and optical density of the lens. The principal of diffractive design is based on scattering of light rays when passing an edge in the material of the lens. One potentially negative aspect of multifocal refractive IOLs is pupil size dependence, another is loss of light energy to higher order diffraction which is not useful to the patient. In clinical studies diffractive lenses resulted in a better outcome in terms of optical quality, better contrast sensitivity and lens photopic phenomena (dysphotopsia such as halos and glare) than in refractive lenses.

Until recently multifocal lenses were typically bifocal with a focus assigned to near and a focus assigned to far vision. However, the intermediate working distance is poorly covered by that multifocal design. Since objects commonly viewed in this distance include computer displays and tablets, the intermediate distance has become a crucial part in daily life. As a consequence of poor intermediate visual acuity there is a need for spectacles for intermediate vision. Variations in the addition of power chosen for near vision provided some intermediate visual acuity but still suboptimal.

Therefore, a new concept of multifocality has been recently introduced, i.e. the trifocal lens. Trifocal lenses provide three focal distances, far, intermediate and near. This ideally results in even less spectacle dependence, including computer work. There are currently 3 trifocal designs available and are being used readily. One potential disadvantage of trifocal compared to bifocal IOLs is that near vision may be slightly poorer with the need for reading glasses with prolonged fine near work.

A slightly modified trifocal design has been recently introduced, that appears to have even better near vision than other trifocal designs as well as the potential for less dysphotopsia with a dilated pupil such as during the night.

02

Conditions studied

  • Cataract

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Keywords

  • Cataract surgery
  • Trifocal IOL
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's planned enrollment of 44 is below the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Prim. Prof. Dr. Oliver Findl, MBA is the lead sponsor of 38 studies on the registry; 2 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

Inclusion criteria

  • Age-related cataract
  • Scheduled for bilateral cataract extraction
  • Motivated to be less spectacle dependant
  • Age 21 and older
  • Corneal astigmatism ≤ 1.5 D (Keratometry, IOL Master 700)
  • written informed consent prior to recruitment

Exclusion criteria

Exclusion Criteria:

  • Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)
  • Retinitis pigmentosa
  • Chronic uveitis
  • Amblyopia
  • Pupil decentration > 1mm center shift
  • preceded retinal surgery
  • preceded Laser-in-situ-Keratomileusis (LASIK)
  • Any ophthalmic abnormality that could compromise visual function or the measurements
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    Trifocal IOL

    The patients will receive two different diffractive trifocal IOLs in each eye (AT Lisa tri vs. Rayner trifocal) during cataract surgery

    Procedure: Cataract surgery

Interventions

  • ProcedureCataract surgery

    During cataract surgery patients will be implanted with the AT Zeiss Lisa tri in one eye and the Rayner trifocal in the contralateral eye

06

What researchers measure

Primary outcomes

  1. Uncorrected Near Visual Acuity

    Uncorrected Near Visual Acuity will be assessed with ETDRS charts

    Time frame: 12 months

Secondary outcomes

  1. Uncorrected and Best corrected Far and Intermediate Visual Acuity,

    Uncorrected and Best corrected Far and Intermediate Visual Acuity will be assessed with ETDRS charts

    Time frame: 12 months

  2. Halo measurements

    Halos will be assessed using the Halometer App on a tablet

    Time frame: 12 months

  3. Reading speed

    Reading speed will be assessed using the Salzburg Reading Desk

    Time frame: 12 months

  4. Defocus curve

    A defocus curve will be done by adding glasses starting from -4.0D to +2.0D to the best corrected far correction

    Time frame: 12 months

  5. Contrast sensitivity

    Contrast sensitivity will be assessed using the Optec Vision tester

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Vienna Institute for Research in Ocular Surgery (VIROS)
    Vienna, 1140, Austria
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03748381
Lead sponsor
Prim. Prof. Dr. Oliver Findl, MBA
Responsible party
Prim. Prof. Dr. Oliver Findl, MBA (Principal Investigator, Vienna Institute for Research in Ocular Surgery) — Sponsor-investigator
First posted
Nov 20, 2018
Start date
Apr 1, 2018
Primary completion
Apr 1, 2020 (estimated)
Completion
Apr 1, 2020 (estimated)
Last update
Nov 23, 2018

Study contacts

Martin Kronschläger, MD
Contact
office@viros.at
01 910 21-57572
Julius Hienert, MD
Contact
office@viros.at
01 910 21-57562

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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