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Age Related CataractsEMONCT05822089

Intraindividual Comparison of EMO IOLs

A study testing phacoemulsification and intraocular lens implantation in people with Age Related Cataracts, run by Medical University of Vienna at 1 site in Austria.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Read more about this study

Who is it for?
Ages 50 to 100 years
Conditions the study is for
Age Related Cataracts
What is being tested?
phacoemulsification and intraocular lens implantation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
461 participants
Where
1 siteAustria
Study dates
13 Dec 2021to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Bilateral age-related cataract planned for phacoemulsification extraction and posterior IOL implantation
  • Age 50 to 100
  • Visual potential in both eyes of 20/25 or better as determined by investigators estimation
  • Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
  • Irregular Astigmatism (Acrysof IQ Vivity IOL, IC-8 Apthera IOL)
  • postoperativ binocular best corrected distance visual acuity (BCVA) ≥ 1.0 decimal (Arm ten (X))
  • Standard cataract surgery with bilateral implantation of a monofocal IOL (Vivinex XC1 or Vivinex XY1) (Arm ten (X))

Who cannot join

  • Preceding intraocular surgery or ocular trauma
  • Relevant other ophthalmic diseases that particularly effects the zonular apparatus (such as severe pseudoexfoliation syndrome, preceding cryocoagulation, trauma)
  • Pupil diameter < 2.0 mm (photopic)
  • Laser treatment
  • Uncontrolled systemic or ocular disease
  • Pregnancy/Nursing
  • childbearing ability

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Austria1 site, 1 recruiting
  • Medical University of Vienna

    Vienna

    Christina Leydolt, MD, +4314040079480, christina.leydolt@meduniwien.ac.at

    Recruiting

Other trials in Austria

About this study

Official title: Comparison of Visual Outcomes of Enhanced Monofocal Intraocular Lenses

The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved investigational plan.

Being tested
phacoemulsification and intraocular lens implantation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • phacoemulsification and intraocular lens implantationProcedure or surgery

    bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (ZCB00) vs. an enhanced monofocal IOL (ICB00)

  • phacoemulsification and intraocular lens implantationProcedure or surgery

    bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (Sensar 1 AAB00) vs. an enhanced monofocal IOL (ICB00)

  • phacoemulsification and intraocular lens implantationProcedure or surgery

    bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (Vivinex XY1) vs. an enhanced monofocal IOL (Vivinex impress)

  • phacoemulsification and intraocular lens implantationProcedure or surgery

    bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (Vivinex impress) in both eyes

  • phacoemulsification and intraocular lens implantationProcedure or surgery

    bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (EnVista) vs. an enhanced monofocal IOL (LuxSmart)

  • phacoemulsification and intraocular lens implantationProcedure or surgery

    bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an extended depth of focus IOL (Acrysof IQ Vivity) in both eyes if low to moderate irregular astigmatism is observed

  • phacoemulsification and intraocular lens implantationProcedure or surgery

    bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an extended depth of focus IOL (IC-8 Apthera) in one eye if irregular astigmatism is observed

  • phacoemulsification and intraocular lens implantationProcedure or surgery

    bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (EnVista) vs. an enhanced monofocal IOL (EnVista Aspire)

  • phacoemulsification and intraocular lens implantationProcedure or surgery

    bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced depth of focus IOL (PureSee) in both eyes

  • phacoemulsification and intraocular lens implantationProcedure or surgery

    bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (Vivinex XY1) in both eyes or a monofocal IOL (Vivinex XC1) in both eyes

Study groups in NCT05822089
Study groupRoleWhat they receive
Monofocal IOL I vs. enhanced monofocal IOL IExperimentalThe investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm one (I) participants will receive a monofocal IOL (ZCB00) vs. an enhanced monofocal IOL (ICB00)
Receives: Procedure: phacoemulsification and intraocular lens implantation
Monofocal IOL II vs. enhanced monofocal IOL IExperimentalThe investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm two (II) participants will receive a monofocal IOL (Sensar 1AAB00) vs. an enhanced monofocal IOL (ICB00)
Receives: Procedure: phacoemulsification and intraocular lens implantation
Monofocal IOL III vs. enhanced monofocal IOL IIExperimentalThe investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm three (III) participants will receive a monofocal IOL (Vivinex XY1)vs. an enhanced monofocal IOL (Vivinex Impress).
Receives: Procedure: phacoemulsification and intraocular lens implantation
Enhanced monofocal IOL II vs. enhanced monofocal IOL IIExperimentalThe investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm four (IV) participants will receive an enhanced monofocal IOL (Vivinex Impress) bilateral with a monovision target
Receives: Procedure: phacoemulsification and intraocular lens implantation
Monofocal IOL IV vs. enhanced monofocal IOL IIIExperimentalThe investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm five (V) participants will receive an enhanced monofocal IOL (EnVista) vs. an enhanced monofocal IOL (LuxSmart)
Receives: Procedure: phacoemulsification and intraocular lens implantation
Extended depth of focus IOL IV in eyes with low to moderate irregular astigmatismExperimentalThe investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm six (VI) participants will receive an extended depth of focus IOL (Acrysof IQ Vivity) in both eyes if low to moderate irregular astigmatism is observed.
Receives: Procedure: phacoemulsification and intraocular lens implantation
Extended Depth of Focus IOL in eyes with irregular astigmatismExperimentalThe investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm seven (VII) participants will receive an extended depth of focus IOL (IC-8 Apthera IOL) in one eye if irregular astigmatism is observed.
Receives: Procedure: phacoemulsification and intraocular lens implantation
Monofocal IOL IV vs. enhanced monofocal IOL IVExperimentalThe investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm eight (VIII) participants will receive an enhanced monofocal IOL (EnVista) vs. an enhanced monofocal IOL (EnVista Aspire)
Receives: Procedure: phacoemulsification and intraocular lens implantation
Enhanced depth of focus IOL I vs. Enhanced depth of focus IOL IExperimentalThe investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm nine (IX) participants will receive an enhanced depth of focus IOL (PureSee) bilateral with a monovision target.
Receives: Procedure: phacoemulsification and intraocular lens implantation
Monofocal IOL VI and monofocal IOL IIIExperimentalThe investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm ten (X) participants will receive a monofocal IOL (Vivinex XC1) bilateral or a monofocal IOL (Vivinex XY1) bilateral.
Receives: Procedure: phacoemulsification and intraocular lens implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Distant corrected intermediate visual acuity

    Primary outcome measure will be monocular distant corrected intermediate visual acuity (DCIVA) of each intraocular lens implanted. DCIVA will be assessed using standardized early treatment diabetic retinopathy study (EDTRS) charts on a logarithm of the minimum angle of resolution (logMAR) scale.

    Measured: 2-6 months

  2. Best-corrected distance visual acuity (BCDVA) - Acrysof IQ Vivity IOL, IC-8 Apthera IOL

    Primary outcome measure will be monocular best-corrected distance visual acuity (BCDVA) of each intraocular lens implanted in eyes with irregular astigmatism. BCDVA will be assessed using standardized early treatment diabetic retinopathy study (EDTRS) charts on a logarithm of the minimum angle of resolution (logMAR) scale.

    Measured: 3-5 months

  3. Contrast sensitivity and reading ability - Vivinex XC1 and Vivinex XY1

    Primary outcome measures for arm ten (X) will be the distance corrected contrast sensitivity and near corrected reading ability and reading speed. Contrast sensitivity will be assessed under standard photopic (85cd/m2) and mesopic (3cd/m2) conditions

    Measured: 2-6 months and 1-5 years

Secondary outcomes (1)
  1. Contrast sensitivity and reading ability

    Secondary outcome measures will be the distance corrected contrast sensitivity and near corrected reading ability and reading speed. Contrast sensitivity will be assessed under standard photopic (85cd/m2) and mesopic (3cd/m2) conditions.

    Measured: 2-6 months and 1-5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2023
  2. Study start13 Dec 2021
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
Intra-individual comparison of 7 groups receiving predefined monofocal and enhanced monofocal intraocular lenses (EMO IOLs). Investigated IOLs will be implanted subsequently according to the study protocol with one IOL type in the dominant eye and the other IOL type in the non- dominant eye.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
461 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05822089
Sponsor's protocol ID
1631/2021
Acronym
EMO
Status last verified
Nov 2025
First submitted
7 Apr 2023
Last updated
5 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing phacoemulsification and intraocular lens implantation in people with Age Related Cataracts, run by Medical University of Vienna 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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 5 Dec 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christina Leydolt, MD (+43 (01) 40 400 79480, christina.leydolt@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distant corrected intermediate visual acuity (time frame: 2-6 months). The study lists 3 primary outcomes in all. 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 5 Dec 2025.

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