Comparison of a New EDOF-IOL With a Standard-EDOF-IOL

Cataract Clinical Trial

Official title:

Comparison of Visual Outcomes After Bilateral Implantation of a New Extended Depth of Focus (EDOF) IOL Twinset With Bilateral Standard EDOF IOLs

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03921762
• Other study ID #: Artis Active
• Status: Recruiting
• Phase: N/A
• Start date: October 29, 2018
• Est. completion date: October 1, 2020

Study information

• Verified date: April 2019
• Source: Vienna Institute for Research in Ocular Surgery
• Contact: Hannah Zwickl, MD
• Phone: +43 1 91021/57564
• Email: office[@]viros.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of the new extended depth of focus (EDOF) intraocular lens (IOL) ARTIS ACTIVE, which is designed as a twinset of IOLs, with the standard EDOF IOL AT Lara .

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. Usually, the characteristic diffractive ring patterns are incorporated on the posterior surface of an IOL, whereas the anterior lens surface remains purely refractive. 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 for the patient. In clinical studies, diffractive lenses resulted in a better outcome in terms of optical quality, better contrast sensitivity, and less photic phenomena (dysphotopsia such as halos and glare) compared to 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 the bifocal design. Since objects commonly viewed in this distance include computer displays and tablets, the intermediate distance has become a crucial part in daily life. 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 introduced, the trifocal lens. Trifocal IOLs provide three focal distances: far, intermediate, and near. This ideally results in even less spectacle dependence, including for computer work. However, one potential disadvantage of trifocal IOLs is slightly poorer near vision compared to bifocal IOLs with need for reading glasses for prolonged fine near work and loss of contrast sensitivity in the intermediate distance.

A better intermediate performance concerning contrast vision compared to trifocal IOLs can be reached using enhanced depth of focus (EDOF) lenses. These IOLs have an extended far focus area which reaches to the intermediate distance, providing high-quality vision over a continuous range of focus, rather than distinct foci with blur in between.

To provide similar outcomes to trifocal IOLs, mix-and-match of additions ("blended vision") is another option, in which additions of multifocal IOLs between both eyes differ. The idea behind it is to improve the contrast in the intermediate distance compared to trifocal IOLs. The combination of +1.75D/ +4D10 and +1.5D/ +3D11 successfully achieved a regular defocus curve, but patient's subjective binocular comfort was not determined. To preserve the binocular balance between the eyes, a difference in addition of 0.5D was proposed and the combination of +2.5D/ +3D showed similar results as trifocal IOLs, except in the intermediate range of -1D and -1.5D.

Therefore, it would be necessary to provide an IOL with a continuum of good visual acuity from distance to 40 cm using binocularity to preserve binocular balance between the eyes. Hence, the primary objective of this study is to compare a new designed twinset of EDOF IOLs, ARTIS ACTIVE (Artis Active Mid and Artis Active Plus), with the standard EDOF IOL AT Lara in binocular visual acuity at 40 cm. Secondary objective is to compare binocular contrast sensitivity (with and without glare), binocular defocus curves with distance correction, monocular and binocular halos, and reading speed between the two IOLs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: October 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 105 Years

Eligibility

Inclusion Criteria:

• > 50 years old

• Bilateral age-related cataract

• Qualify for bilateral implantation within 1 month

• No previous refractive or ocular surgery

• Available IOL dioptre range: 18 to 27D

• Expected postoperative astigmatism = 0.75D

Exclusion Criteria:

• Pupil > 4 mm

• Occupation requiring night-time driving or any occupation incompatible with multifocality

• Acute or chronic disease or illness that would increase risk or confound study results [e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma, epiretinal membrane, cornea guttata, etc….] found to be relevant by the investigators

• Amblyopia, strabismus

• Extremely shallow anterior chamber

• Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, uveitis, Marfan's syndrome)

• Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/ scotopic conditions)

• Instability to place the intraocular lens safely at the location planned

• Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)

Related Conditions & MeSH terms

• Cataract

Intervention

Procedure:
• Cataract surgery with Artis Active IOLs
Patients will be implanted with the Artis Active IOLs during cataract surgery
• Cataract surgery with AT Lara IOLs
Patients will be implanted with the AT Lara IOLs during cataract surgery

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	Assessment of binocular near visual acuity	Binocular near visual acuity in logMar will be measured at 40 cm distance using an ETDRS visual acuity chart	12 months
Secondary	Assessment of binocular far and intermediate visual acuity	Binocular far and intermediate visual acuity in logMar will be measured at 4 metre and 70 cm distance using an ETDRS visual acuity chart	12 months
Secondary	Assessment of halos	Extent of halos will be measured and analysed using the Aston halometer	12 months
Secondary	Assessment of binocular contrast sensitivity	Binocular contrast sensitivity will be measured using the Optec Vision tester under mesopic and photopic conditions	12 months
Secondary	Assessment of reading speed	Patients reading speed will be measured using the Salzburg Reading Desk	12 months