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CataractNCT03748381

Comparison of 2 Diffractive Trifocal IOLs

A study testing Cataract surgery in people with Cataract, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 21 to 105 years
Conditions the study is for
Cataract
What is being tested?
Cataract surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteAustria
Study dates
1 Apr 2018to 1 Apr 2020
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 21 to 105 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Martin Kronschläger, MD contact

01 910 21-57572

office@viros.at

Julius Hienert, MD contact

01 910 21-57562

office@viros.at

Austria1 site, 1 recruiting
  • Vienna Institute for Research in Ocular Surgery (VIROS)

    Vienna, 1140

    Martin Kronschläger, MD, 01 91021-57572, office@viros.at

    Julius Hienert, MD, 01 91021-57564, office@viros.at

    Recruiting

Other trials in Austria

About this study

Official title: Comparison of Visual Performance of 2 Diffractive Trifocal Intraocular Lenses: a Randomised Controlled Trial

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.

Conditions
Cataract
Being tested
Cataract surgery
Keywords
Cataract surgery, Trifocal IOL
Medical subject headings
Cataract

What participants receive

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

  • Cataract surgeryProcedure or 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

Study groups in NCT03748381
Study groupRoleWhat they receive
Trifocal IOLExperimentalThe patients will receive two different diffractive trifocal IOLs in each eye (AT Lisa tri vs. Rayner trifocal) during cataract surgery
Receives: Procedure: Cataract surgery

What is being measured

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

  1. Uncorrected Near Visual Acuity

    Uncorrected Near Visual Acuity will be assessed with ETDRS charts

    Measured: 12 months

Secondary outcomes (5)
  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

    Measured: 12 months

  2. Halo measurements

    Halos will be assessed using the Halometer App on a tablet

    Measured: 12 months

  3. Reading speed

    Reading speed will be assessed using the Salzburg Reading Desk

    Measured: 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

    Measured: 12 months

  5. Contrast sensitivity

    Contrast sensitivity will be assessed using the Optec Vision tester

    Measured: 12 months

Timeline

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

  1. First posted20 Nov 2018
  2. Study start1 Apr 2018
  3. Primary completion1 Apr 2020 (estimated)
  4. Study completion1 Apr 2020 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03748381
Sponsor's protocol ID
Trifocal
Status last verified
Nov 2018
First submitted
19 Nov 2018
Last updated
23 Nov 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Cataract surgery in people with Cataract, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.

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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 23 Nov 2018. 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 Austria. 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?

Results are not available in the source record.

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

Contact Martin Kronschläger, MD (01 910 21-57572, office@viros.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Uncorrected Near Visual Acuity (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 23 Nov 2018.

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