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RecruitingNCT07925840Updated Nov 9, 2026

Rotational Stability of the Acunex Vario Toric

An interventional study of EDOF IOL in Cataract, sponsored by Prim. Prof. Dr. Oliver Findl, MBA. Recruiting at 1 site in Austria. Open to participants aged 21 Years to 105 Years. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Prim. Prof. Dr. Oliver Findl, MBA · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Mar 2026, registered Nov 2026).
  • Started Mar 2026; still recruiting 7 months later.
Updated Nov 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
21 Years to 105 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Cataract

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Keywords

  • cataract
  • cataract surgery
  • toric intraocular lens
  • EDOF intraocular lens
03

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's planned enrollment of 38 is below the median of 79 across 1,092 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Prim. Prof. Dr. Oliver Findl, MBA is the lead sponsor of 39 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 105 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 prior to surgery

Exclusion criteria

Exclusion Criteria:

  • 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (estimated)

Study arms

  • Experimental
    Acunex Vario toric

    Patient will recieve the Acunex Vario IOL during cataract surgery

    Device: EDOF IOL

Interventions

  • DeviceEDOF IOL

    The Acunex Vario toric IOL, toric EDOF IOL, will be implanted

06

What researchers measure

Primary outcomes

  1. IOL axis rotation

    The IOL axis rotation before and after cataract surgery will be analyzed with retroillumination photographs

    Time frame: 12 monthes

Secondary outcomes

  1. 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

    Time frame: 12 months

  2. 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

    Time frame: 12 months

  3. Refraction

    Refraction before and after cataract surgery will be determined using trial frame glasses and Jackson cross cylinders

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07925840
Lead sponsor
Prim. Prof. Dr. Oliver Findl, MBA
Responsible party
Prim. Prof. Dr. Oliver Findl, MBA (Principal Investigator, Vienna Institute for Research in Ocular Surgery) — Sponsor-investigator
First posted
Nov 9, 2026
Start date
Mar 27, 2026
Primary completion
Dec 1, 2027 (estimated)
Completion
Jul 1, 2028 (estimated)
Last update
Nov 9, 2026

Study contacts

Oliver Findl, Prim. Prof. Dr.
Contact
office@viros.at
+43 1 91021 ext. 57564
Johannes Zeilinger, MD
Contact
office@viros.at
+43 1 91021 ext. 57564
Oliver Findl, Prim. Prof. Dr.
principal investigator · Vienna Institute for Research in Ocular Surgery

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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