Rotational Stability of the Acunex Vario Toric
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.
Study Overview
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Johannes Zeilinger, MD
- Phone Number: 57564 +43 1 91021
- Email: office@viros.at
Study Contact Backup
- Name: Oliver Findl, Prim. Prof. Dr.
- Phone Number: 57564 +43 1 91021
- Email: office@viros.at
Study Locations
-
-
-
Vienna, Austria, 1140
- Recruiting
- Vienna Institute for Research in Ocular Surgery
-
Contact:
- Johannes Zeilinger, MD
- Phone Number: 57564 +43 1 91021
- Email: office@viros.at
-
Contact:
- Oliver Findl, Prim. Prof. Dr.
- Phone Number: 57564 +43 1 91021
- Email: office@viros.at
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Acunex Vario toric
Patient will recieve the Acunex Vario IOL during cataract surgery |
The Acunex Vario toric IOL, toric EDOF IOL, will be implanted |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
IOL axis rotation
Time Frame: 12 monthes
|
The IOL axis rotation before and after cataract surgery will be analyzed with retroillumination photographs |
12 monthes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Distance visual acuity
Time Frame: 12 months
|
Uncorrected and corrected distance visual acuity before and after cataract surgery will be determined using ETDRS-charts in a distance of 4 metres |
12 months
|
|
Intermediate visual acuity
Time Frame: 12 months
|
Uncorrected and corrected intermediate visual acuity before and after cataract surgery will be determined using ETDRS-charts in a distance of 66 centimetres |
12 months
|
|
Refraction
Time Frame: 12 months
|
Refraction before and after cataract surgery will be determined using trial frame glasses and Jackson cross cylinders |
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Oliver Findl, Prim. Prof. Dr., Vienna Institute for Research in Ocular Surgery
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Acunex Vario toric
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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