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

Primary Purpose

Cataract

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Cataract surgery with Artis Active IOLs
Cataract surgery with AT Lara IOLs
Sponsored by
Prim. Prof. Dr. Oliver Findl, MBA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Cataract surgery, Enhanced depth of focus (EDOF), Intraocular lens

Eligibility Criteria

50 Years - 105 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Vienna Institute for Research in Ocular Surgery (VIROS)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Artis Active IOL

AT Lara IOL

Arm Description

Artis Active IOLs (Artis Active Mid, Artis Active Plus) will be implanted in patients eyes during cataract surgery

AT Lara IOLs will be implanted in patients eyes during cataract surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Assessment of halos
Extent of halos will be measured and analysed using the Aston halometer
Assessment of binocular contrast sensitivity
Binocular contrast sensitivity will be measured using the Optec Vision tester under mesopic and photopic conditions
Assessment of reading speed
Patients reading speed will be measured using the Salzburg Reading Desk

Full Information

First Posted
April 17, 2019
Last Updated
April 17, 2019
Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
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1. Study Identification

Unique Protocol Identification Number
NCT03921762
Brief Title
Comparison of a New EDOF-IOL With a Standard-EDOF-IOL
Official Title
Comparison of Visual Outcomes After Bilateral Implantation of a New Extended Depth of Focus (EDOF) IOL Twinset With Bilateral Standard EDOF IOLs
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 29, 2018 (Actual)
Primary Completion Date
April 1, 2020 (Anticipated)
Study Completion Date
October 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prim. Prof. Dr. Oliver Findl, MBA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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 .
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract surgery, Enhanced depth of focus (EDOF), Intraocular lens

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Artis Active IOL
Arm Type
Experimental
Arm Description
Artis Active IOLs (Artis Active Mid, Artis Active Plus) will be implanted in patients eyes during cataract surgery
Arm Title
AT Lara IOL
Arm Type
Experimental
Arm Description
AT Lara IOLs will be implanted in patients eyes during cataract surgery
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery with Artis Active IOLs
Intervention Description
Patients will be implanted with the Artis Active IOLs during cataract surgery
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery with AT Lara IOLs
Intervention Description
Patients will be implanted with the AT Lara IOLs during cataract surgery
Primary Outcome Measure Information:
Title
Assessment of binocular near visual acuity
Description
Binocular near visual acuity in logMar will be measured at 40 cm distance using an ETDRS visual acuity chart
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Assessment of binocular far and intermediate visual acuity
Description
Binocular far and intermediate visual acuity in logMar will be measured at 4 metre and 70 cm distance using an ETDRS visual acuity chart
Time Frame
12 months
Title
Assessment of halos
Description
Extent of halos will be measured and analysed using the Aston halometer
Time Frame
12 months
Title
Assessment of binocular contrast sensitivity
Description
Binocular contrast sensitivity will be measured using the Optec Vision tester under mesopic and photopic conditions
Time Frame
12 months
Title
Assessment of reading speed
Description
Patients reading speed will be measured using the Salzburg Reading Desk
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah Zwickl, MD
Phone
+43 1 91021/57564
Email
office@viros.at
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel Ruiss, MSc.
Phone
+43 1 91021/57564
Email
office@viros.at
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery (VIROS)
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannah Zwickl, MD
Phone
+43 1 91021/57564
Email
office@viros.at
First Name & Middle Initial & Last Name & Degree
Manuel Ruiss, MSc.
Phone
+43 1 91021/57564
Email
office@viros.at

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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