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Comparison of 2 Diffractive Trifocal IOLs

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03748381
Enrollment
44
Registered
2018-11-20
Start date
2018-04-01
Completion date
2020-04-01
Last updated
2018-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

Cataract surgery, Trifocal IOL

Brief 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.

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.

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

Sponsors

Prim. Prof. Dr. Oliver Findl, MBA
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 105 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Uncorrected Near Visual Acuity12 monthsUncorrected Near Visual Acuity will be assessed with ETDRS charts

Secondary

MeasureTime frameDescription
Uncorrected and Best corrected Far and Intermediate Visual Acuity,12 monthsUncorrected and Best corrected Far and Intermediate Visual Acuity will be assessed with ETDRS charts
Halo measurements12 monthsHalos will be assessed using the Halometer App on a tablet
Reading speed12 monthsReading speed will be assessed using the Salzburg Reading Desk
Defocus curve12 monthsA defocus curve will be done by adding glasses starting from -4.0D to +2.0D to the best corrected far correction
Contrast sensitivity12 monthsContrast sensitivity will be assessed using the Optec Vision tester

Countries

Austria

Contacts

Primary ContactMartin Kronschläger, MD
office@viros.at01 910 21-57572
Backup ContactJulius Hienert, MD
office@viros.at01 910 21-57562

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026