Comparison of 2 Diffractive Trifocal IOLs

Sponsor
Prim. Prof. Dr. Oliver Findl, MBA (Other)
Overall Status
Unknown status
CT.gov ID
NCT03748381
Collaborator
(none)
44
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Cataract surgery
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Visual Performance of 2 Diffractive Trifocal Intraocular Lenses: a Randomised Controlled Trial
Actual Study Start Date :
Apr 1, 2018
Anticipated Primary Completion Date :
Apr 1, 2020
Anticipated Study Completion Date :
Apr 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Uncorrected Near Visual Acuity [12 months]

    Uncorrected Near Visual Acuity will be assessed with ETDRS charts

Secondary Outcome Measures

  1. Uncorrected and Best corrected Far and Intermediate Visual Acuity, [12 months]

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

  2. Halo measurements [12 months]

    Halos will be assessed using the Halometer App on a tablet

  3. Reading speed [12 months]

    Reading speed will be assessed using the Salzburg Reading Desk

  4. Defocus curve [12 months]

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

  5. Contrast sensitivity [12 months]

    Contrast sensitivity will be assessed using the Optec Vision tester

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 105 Years
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Vienna Institute for Research in Ocular Surgery (VIROS)ViennaAustria1140

Sponsors and Collaborators

  • Prim. Prof. Dr. Oliver Findl, MBA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prim. Prof. Dr. Oliver Findl, MBA, Principal Investigator, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier:
NCT03748381
Other Study ID Numbers:
  • Trifocal
First Posted:
Nov 20, 2018
Last Update Posted:
Nov 23, 2018
Last Verified:
Nov 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Prim. Prof. Dr. Oliver Findl, MBA, Principal Investigator, Vienna Institute for Research in Ocular Surgery
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 23, 2018