Age-related CataractNCT05573529
EDOF and Multifocal IOL Study
A study testing phacoemulsification and intraocular lens implantation and intraocular lens implantation in people with Age-related Cataract, run by Medical University of Vienna at 1 site in Austria.
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 90 years
- Conditions the study is for
- Age-related Cataract
- What is being tested?
- phacoemulsification and intraocular lens implantation and intraocular lens implantation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 9 Nov 2020to 5 Feb 2025
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned
- Age 50-90
- Visual potential in both eyes of 20/30 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
Who cannot join
- Preceding ocular surgery or trauma
- Relevant other ophthalmic diseases (such as retinal degenerations, etc.)
- Uncontrolled systemic or ocular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Visual Outcomes and Patient Satisfaction After Bilateral Implantation of EDOF and Multifcoal IOLs- a Prospective Randomized Controlled Trial
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.
- Conditions
- Age-related Cataract
- Being tested
- phacoemulsification and intraocular lens implantation, 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
intraocular lens implantationDevice
intraocular lens implantation includes EDOF IOL implantation in the dominant eye and multifocal IOL implantation in the non-dominant eye after phacoemulsification
| Study group | Role | What they receive |
|---|---|---|
| Edof IOL vs. multifocal IOL I | Experimental | 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. In Arm one (I) participants will receive Edof IOL one (I) vs. multifocal IOL one (I). Receives: Procedure: phacoemulsification and intraocular lens implantation; Device: intraocular lens implantation |
| Edof IOL vs. multifocal IOL II | Experimental | 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. In Arm two (II) participants will receive Edof IOL one (I) vs. multifocal IOL two (II). Receives: Procedure: phacoemulsification and intraocular lens implantation; Device: intraocular lens implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
distant corrected near visual acuity
Primary outcome measure will be monocular distant corrected near visual acuity (DCNVA) of each intraocular lens implanted. DCNVA will be assessed using standardized early treatment diabetic retinopathy study (EDTRS) charts on a logarithm of the minimum angle of resolution (logMAR) scale.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start9 Nov 2020
- Primary completion23 Mar 2023
- Study completion5 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related CataractStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Model description
- intra-individual comparison of two groups recieving predefined EDOF and multifocal intraocular lenses. In group one (I), the EDOF lens one (I) will be implanted in the dominant eye and the multifocal lens one (I) in the non-dominant eye. Subsequently, study participants in group two (II) will receive the EDOF lens one (I) in the dominant eye and the multifocal lens two (II) in the non-dominant eye.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Leydolt, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573529
- Sponsor's protocol ID
- 1163/2020
- Status last verified
- Jun 2025
- First submitted
- 9 Sep 2022
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- 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 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Visual Outcomes and Patient Satisfaction After Bilateral Implantation of EDOF and Multifcoal IOLs- a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05573529
- Acronym / sponsor ID
- 1163/2020
- Conditions
- Age-related Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 5 Feb 2025 (actual)
- First posted
- 10 Oct 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- intra-individual comparison of two groups recieving predefined EDOF and multifocal intraocular lenses. In group one (I), the EDOF lens one (I) will be implanted in the dominant eye and the multifocal lens one (I) in the non-dominant eye. Subsequently, study participants in group two (II) will receive the EDOF lens one (I) in the dominant eye and the multifocal lens two (II) in the non-dominant eye.
| Arm | Type | Receives |
|---|---|---|
| Edof IOL vs. multifocal IOL I | Experimental | Procedure: phacoemulsification and intraocular lens implantation, Device: intraocular lens implantationThe 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 Edof IOL one (I) vs. multifocal IOL one (I). |
| Edof IOL vs. multifocal IOL II | Experimental | Procedure: phacoemulsification and intraocular lens implantation, Device: intraocular lens implantationThe 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 Edof IOL one (I) vs. multifocal IOL two (II). |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned
- Age 50-90
- Visual potential in both eyes of 20/30 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
Key exclusion criteria (3 listed)
- Preceding ocular surgery or trauma
- Relevant other ophthalmic diseases (such as retinal degenerations, etc.)
- Uncontrolled systemic or ocular disease
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 |
|---|---|---|
| phacoemulsification and intraocular lens implantationbilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation | Procedure or surgery | Edof IOL vs. multifocal IOL I, Edof IOL vs. multifocal IOL II |
| intraocular lens implantationintraocular lens implantation includes EDOF IOL implantation in the dominant eye and multifocal IOL implantation in the non-dominant eye after phacoemulsification | Device | Edof IOL vs. multifocal IOL I, Edof IOL vs. multifocal IOL II |
Primary outcome
distant corrected near visual acuity
Time frame: 6 months
Primary outcome measure will be monocular distant corrected near visual acuity (DCNVA) of each intraocular lens implanted. DCNVA will be assessed using standardized early treatment diabetic retinopathy study (EDTRS) charts on a logarithm of the minimum angle of resolution (logMAR) scale.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phacoemulsification and intraocular lens implantation and intraocular lens implantation in people with Age-related Cataract, 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 18 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
distant corrected near visual acuity (time frame: 6 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 18 Jun 2025.