CataractNCT07925840
Rotational Stability of the Acunex Vario Toric
A study testing EDOF IOL in people with Cataract, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.
Trial summary
Efficacy of the rotational stability and astigmatism correction of a toric EDOF IOL, the Acunex Vario toric. Read more about this study
- Who is it for?
- Ages 21 to 105 years
- Conditions the study is for
- Cataract
- What is being tested?
- EDOF IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteAustria
- Study dates
- 27 Mar 2026to 1 Jul 2028
- 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 21 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bilateral age-related cataract scheduled for cataract surgery
- Age 21 or older
- Predefined postoperative residual astigmatism to be < 0.5 D (calculated with Barrett total K toric calculator)
- Calculated IOL power within the range of the investigated IOL
- Pupil size ≥ 5 mm (in mydriasis)
- Willingness to comply with the postoperative follow-up examination schedule
- Written informed consent prior to surgery
Who cannot join
- Previous ocular surgery or trauma
- Extreme shallow anterior chamber
- Uncontrolled systemic or ocular disease
- Associated corneal pathologies (e.g., edema, scarring) or relevant other ophthalmic diseases that may result in altered visual outcome or lens stability (e.g., pseudoexfoliation syndrome, floppy iris syndrome, glaucoma, retinal disease)
- Concurrent participation in another clinical investigation
- Pregnancy or lactation (pregnancy test will be performed in women of reproductive age)
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
- Recruiting
Vienna Institute for Research in Ocular Surgery
Vienna, 1140
Oliver Findl, Prim. Prof. Dr., +43 1 91021 ext. 57564, office@viros.at
Johannes Zeilinger, MD, +43 1 91021 ext. 57564, office@viros.at
About this study
Official title: Evaluation of the Rotational Stability of the Acunex Vario Toric Intraocular Lens
Efficacy of the rotational stability and astigmatism correction of a toric EDOF IOL, the Acunex Vario toric.
Read the detailed description
Recent advances in cataract surgery technology have transformed the procedure from a purely vision-restoring approach into a procedure for correcting presbyopia. Patients' resulting higher expectations regarding freedom from spectacles have led to advances in intraocular lens (IOL) technology in recent years. The implantation of a standard monofocal IOL designed to achieve emmetropia results in a high level of patient satisfaction with regard to distance vision. However, spectacles are still required for intermediate and near vision.
One approach to achieving freedom from spectacles at all distances is the use of multifocal IOLs. Compared with monofocal IOLs, however, these lenses are more frequently associated with photic phenomena such as glare and halos, as well as reduced contrast sensitivity. Another approach to minimize the need for spectacles is the use of IOLs with extended depth of focus (EDOF). These lenses feature an extended distance focus range that extends into the intermediate range, thereby offering high visual quality across a continuous focus range. Unlike trifocal IOLs, which split the light into different focal points, the extended focus of these IOLs is designed to improve contrast perception in the intermediate range and reduce light-related phenomena.
Furthermore, residual corneal astigmatism is an important factor in achieving post-operative freedom from spectacles, and its correction is necessary to achieve the best possible visual performance. The most widely used and effective approach to correcting corneal astigmatism is the implantation of a toric IOL. To ensure that these lenses achieve the desired effect, they must be positioned precisely along the intended axis, as any rotation of a toric IOL can reduce its ability to correct astigmatism.
Particularly in the case of IOLs designed to correct presbyopia, such as trifocal or EDOF lenses, it is therefore important to correct corneal astigmatism in order to achieve the best possible post-operative visual outcome. The aim of this study is therefore to analyze the efficacy and rotational stability of a toric EDOF IOL (Acunex Vario toric, AN6VT).
38 eyes from 38 patients will be included into the study, into each eye an AN6VT IOL will be implanted. Follow-up examinations will take place 1 hour, 1 week after surgery on the first eye and 1 week after surgery on the second eye, and 4-6 months post-operatively.
- Conditions
- Cataract
- Being tested
- EDOF IOL
- Keywords
- cataract, cataract surgery, toric intraocular lens, 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.
EDOF IOLDevice
The Acunex Vario toric IOL, toric EDOF IOL, will be implanted
| Study group | Role | What they receive |
|---|---|---|
| Acunex Vario toric | Experimental | Patient will recieve the Acunex Vario IOL during cataract surgery Receives: Device: EDOF IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOL axis rotation
The IOL axis rotation before and after cataract surgery will be analyzed with retroillumination photographs
Measured: 12 monthes
Secondary outcomes (3)
Distance visual acuity
Uncorrected and corrected distance visual acuity before and after cataract surgery will be determined using ETDRS-charts in a distance of 4 metres
Measured: 12 months
Intermediate visual acuity
Uncorrected and corrected intermediate visual acuity before and after cataract surgery will be determined using ETDRS-charts in a distance of 66 centimetres
Measured: 12 months
Refraction
Refraction before and after cataract surgery will be determined using trial frame glasses and Jackson cross cylinders
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 posted9 Nov 2026
- Study start27 Mar 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jul 2028 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 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
- Investigators
- Oliver Findl, Prim. Prof. Dr., Principal investigator, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07925840
- Sponsor's protocol ID
- Acunex Vario toric
- Status last verified
- Nov 2026
- First submitted
- 3 Nov 2026
- Last updated
- 9 Nov 2026
- 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 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Rotational Stability of the Acunex Vario Toric Intraocular Lens
- ClinicalTrials.gov ID
- NCT07925840
- Acronym / sponsor ID
- Acunex Vario toric
- Conditions
- Cataract
- Keywords
- cataract, cataract surgery, toric intraocular lens, EDOF intraocular lens
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBAUniversity, hospital or other
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 9 Nov 2026 (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.
Efficacy of the rotational stability and astigmatism correction of a toric EDOF IOL, the Acunex Vario toric.
Detailed description
Recent advances in cataract surgery technology have transformed the procedure from a purely vision-restoring approach into a procedure for correcting presbyopia. Patients' resulting higher expectations regarding freedom from spectacles have led to advances in intraocular lens (IOL) technology in recent years. The implantation of a standard monofocal IOL designed to achieve emmetropia results in a high level of patient satisfaction with regard to distance vision. However, spectacles are still required for intermediate and near vision.
One approach to achieving freedom from spectacles at all distances is the use of multifocal IOLs. Compared with monofocal IOLs, however, these lenses are more frequently associated with photic phenomena such as glare and halos, as well as reduced contrast sensitivity. Another approach to minimize the need for spectacles is the use of IOLs with extended depth of focus (EDOF). These lenses feature an extended distance focus range that extends into the intermediate range, thereby offering high visual quality across a continuous focus range. Unlike trifocal IOLs, which split the light into different focal points, the extended focus of these IOLs is designed to improve contrast perception in the intermediate range and reduce light-related phenomena.
Furthermore, residual corneal astigmatism is an important factor in achieving post-operative freedom from spectacles, and its correction is necessary to achieve the best possible visual performance. The most widely used and effective approach to correcting corneal astigmatism is the implantation of a toric IOL. To ensure that these lenses achieve the desired effect, they must be positioned precisely along the intended axis, as any rotation of a toric IOL can reduce its ability to correct astigmatism.
Particularly in the case of IOLs designed to correct presbyopia, such as trifocal or EDOF lenses, it is therefore important to correct corneal astigmatism in order to achieve the best possible post-operative visual outcome. The aim of this study is therefore to analyze the efficacy and rotational stability of a toric EDOF IOL (Acunex Vario toric, AN6VT).
38 eyes from 38 patients will be included into the study, into each eye an AN6VT IOL will be implanted. Follow-up examinations will take place 1 hour, 1 week after surgery on the first eye and 1 week after surgery on the second eye, and 4-6 months post-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acunex Vario toric | Experimental | Device: EDOF IOLPatient will recieve the Acunex Vario IOL during cataract surgery |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Bilateral age-related cataract scheduled for cataract surgery
- Age 21 or older
- Predefined postoperative residual astigmatism to be < 0.5 D (calculated with Barrett total K toric calculator)
- Calculated IOL power within the range of the investigated IOL
- Pupil size ≥ 5 mm (in mydriasis)
Key exclusion criteria (6 listed)
- Previous ocular surgery or trauma
- Extreme shallow anterior chamber
- Uncontrolled systemic or ocular disease
- Associated corneal pathologies (e.g., edema, scarring) or relevant other ophthalmic diseases that may result in altered visual outcome or lens stability (e.g., pseudoexfoliation syndrome, floppy iris syndrome, glaucoma, retinal disease)
- Concurrent participation in another clinical investigation
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 |
|---|---|---|
| EDOF IOLThe Acunex Vario toric IOL, toric EDOF IOL, will be implanted | Device | Acunex Vario toric |
Primary outcome
IOL axis rotation
Time frame: 12 monthes
The IOL axis rotation before and after cataract surgery will be analyzed with retroillumination photographs
3 secondary outcomes
Distance visual acuity
Time frame: 12 months
Intermediate visual acuity
Time frame: 12 months
Refraction
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2026.
- 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.
Oliver Findl, Prim. Prof. Dr. principal investigator
Vienna Institute for Research in Ocular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EDOF IOL 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 7 inclusion and 6 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 9 Nov 2026. 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 Oliver Findl, Prim. Prof. Dr. (+43 1 91021 ext. 57564, office@viros.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOL axis rotation (time frame: 12 monthes). 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 9 Nov 2026.