Rotational Stability of the Acunex Vario Toric

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates the rotational stability and astigmatism correction provided by the Acunex Vario toric EDOF intraocular lens in adults with bilateral age-related cataracts. Eligible participants will undergo cataract surgery with implantation of the toric EDOF IOL in both eyes, with specific preoperative astigmatism criteria and lens power within the study range. Outcomes focus on lens rotation over time and visual performance across distances, aiming to reduce dependence on spectacles while minimizing photic phenomena. The trial adheres to standard postoperative follow-up to assess stability, refractive outcomes, and safety in a real-world surgical setting.

Why it matters

Who can join: the full rules

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 informed consent prior to surgery

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)

Where it's running

• Vienna Institute for Research in Ocular Surgery
  Vienna, Austria Recruiting

Study contacts

• Principal investigator: Oliver Findl, Prim. Prof. Dr. — Vienna Institute for Research in Ocular Surgery
• Study coordinator: Oliver Findl, Prim. Prof. Dr.
• Email: office@viros.at
• Phone: +43 1 91021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.