CataractNCT03921762
Comparison of a New EDOF-IOL With a Standard-EDOF-IOL
A study testing Cataract surgery with Artis Active IOLs and Cataract surgery with AT Lara IOLs in people with Cataract, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.
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 . Read more about this study
- Who is it for?
- Ages 50 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Cataract surgery with Artis Active IOLs and Cataract surgery with AT Lara IOLs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteAustria
- Study dates
- 29 Oct 2018to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- 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)
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Vienna Institute for Research in Ocular Surgery (VIROS)
Vienna, 1140
Hannah Zwickl, MD, +43 1 91021/57564, office@viros.at
Manuel Ruiss, MSc., +43 1 91021/57564, office@viros.at
About this study
Official title: Comparison of Visual Outcomes After Bilateral Implantation of a New Extended Depth of Focus (EDOF) IOL Twinset With Bilateral Standard EDOF IOLs
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 .
Read the 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.
- Conditions
- Cataract
- Being tested
- Cataract surgery with Artis Active IOLs, Cataract surgery with AT Lara IOLs
- Keywords
- Cataract surgery, Enhanced depth of focus (EDOF), Intraocular lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgery with Artis Active IOLsProcedure or surgery
Patients will be implanted with the Artis Active IOLs during cataract surgery
Cataract surgery with AT Lara IOLsProcedure or surgery
Patients will be implanted with the AT Lara IOLs during cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| Artis Active IOL | Experimental | Artis Active IOLs (Artis Active Mid, Artis Active Plus) will be implanted in patients eyes during cataract surgery Receives: Procedure: Cataract surgery with Artis Active IOLs |
| AT Lara IOL | Experimental | AT Lara IOLs will be implanted in patients eyes during cataract surgery Receives: Procedure: Cataract surgery with AT Lara IOLs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (4)
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
Measured: 12 months
Assessment of halos
Extent of halos will be measured and analysed using the Aston halometer
Measured: 12 months
Assessment of binocular contrast sensitivity
Binocular contrast sensitivity will be measured using the Optec Vision tester under mesopic and photopic conditions
Measured: 12 months
Assessment of reading speed
Patients reading speed will be measured using the Salzburg Reading Desk
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start29 Oct 2018
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921762
- Sponsor's protocol ID
- Artis Active
- Status last verified
- Apr 2019
- First submitted
- 17 Apr 2019
- Last updated
- 19 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Visual Outcomes After Bilateral Implantation of a New Extended Depth of Focus (EDOF) IOL Twinset With Bilateral Standard EDOF IOLs
- ClinicalTrials.gov ID
- NCT03921762
- Acronym / sponsor ID
- Artis Active
- Conditions
- Cataract
- Keywords
- Cataract surgery, Enhanced depth of focus (EDOF), Intraocular lens
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBAUniversity, hospital or other
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artis Active IOL | Experimental | Procedure: Cataract surgery with Artis Active IOLsArtis Active IOLs (Artis Active Mid, Artis Active Plus) will be implanted in patients eyes during cataract surgery |
| AT Lara IOL | Experimental | Procedure: Cataract surgery with AT Lara IOLsAT Lara IOLs will be implanted in patients eyes during cataract surgery |
Who may qualify
- Ages
- 50 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- > 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cataract surgery with Artis Active IOLsPatients will be implanted with the Artis Active IOLs during cataract surgery | Procedure or surgery | Artis Active IOL |
| Cataract surgery with AT Lara IOLsPatients will be implanted with the AT Lara IOLs during cataract surgery | Procedure or surgery | AT Lara IOL |
Primary outcome
Assessment of binocular near visual acuity
Time frame: 12 months
Binocular near visual acuity in logMar will be measured at 40 cm distance using an ETDRS visual acuity chart
4 secondary outcomes
Assessment of binocular far and intermediate visual acuity
Time frame: 12 months
Assessment of halos
Time frame: 12 months
Assessment of binocular contrast sensitivity
Time frame: 12 months
Assessment of reading speed
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cataract surgery with Artis Active IOLs and Cataract surgery with AT Lara IOLs in people with Cataract, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hannah Zwickl, MD (+43 1 91021/57564, office@viros.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of binocular near visual acuity (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.