Comparison of 2 Diffractive Trifocal IOLs

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03748381
• Other study ID #: Trifocal
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: April 1, 2020

Study information

• Verified date: November 2018
• Source: Vienna Institute for Research in Ocular Surgery
• Contact: Martin Kronschläger, MD
• Phone: 01 910 21-57572
• Email: office[@]viros.at
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 105 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

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

Locations

Country	Name	City	State
Austria	Vienna Institute for Research in Ocular Surgery (VIROS)	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Prim. Prof. Dr. Oliver Findl, MBA

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uncorrected Near Visual Acuity	Uncorrected Near Visual Acuity will be assessed with ETDRS charts	12 months
Secondary	Uncorrected and Best corrected Far and Intermediate Visual Acuity,	Uncorrected and Best corrected Far and Intermediate Visual Acuity will be assessed with ETDRS charts	12 months
Secondary	Halo measurements	Halos will be assessed using the Halometer App on a tablet	12 months
Secondary	Reading speed	Reading speed will be assessed using the Salzburg Reading Desk	12 months
Secondary	Defocus curve	A defocus curve will be done by adding glasses starting from -4.0D to +2.0D to the best corrected far correction	12 months
Secondary	Contrast sensitivity	Contrast sensitivity will be assessed using the Optec Vision tester	12 months