Clinical trial NCT04933487: Rotational Stability Analysis of a Toric Monofocal IOL
Official title: Prospective Evaluation of the Rotational Stability of the Ankoris Intraocular Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lens Opacities
Astigmatism
Keywords: Intraocular Lens
Monofocal
Toric Lens
Lead sponsor: Beaver-Visitec International, Inc.
Sponsor class: INDUSTRY
Collaborators: name: targomedGmbH
First posted: 2021-06-21
Enrollment: 23
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-center, prospective PMCF study whereby patients undergoing routine cataract surgery will have monolateral implantation of hydrophilic monofocal toric intraocular lens Ankoris.

Detailed description: This is a single-center, prospective, nonrandomized PMCF study whereby patients undergoing routine cataract surgery will have monolateral implantation of hydrophilic monofocal toric intraocular lens (Ankoris). The device under investigation is manufactured by the sponsor of this study. The refractive power of the lens has a spherical and a cylindrical component. The IOLs will be implanted in the course of routine cataract surgery and will benefit to patients suffering from cataract development and showing pre-existing corneal astigmatism.

The primary objective of this study is to determine the rotational stability of the Ankoris intraocular lens. The secondary objective is to measure the residual astigmatism after Ankoris implantation with respect to the targeted astigmatism correction.

In total approx. 20 eyes of 20 patients will be recruited for this clinical study.

Follow-ups will be performed 1 day, 1 month, and 3 months after cataract surgery. Subjects would have the option for unscheduled visits if required medically.

Eligibility criteria: Inclusion Criteria:

* Cataracteous Eyes with no comorbidity
* Regular corneal astigmatism \>1 dioptre and \<3D determined by an automatic keratometer (regularity determined by the topography of the keratometry).
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Signed informed consent •\>50 years old

Exclusion Criteria:

* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...)
* Any ocular comorbidity
* History of ocular trauma or prior ocular surgery including refractive procedures
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, Marfan's syndrome)
* Pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)

Primary outcomes:
measure: Rotational stability - Photograph of IOL with dilated pupil to asses IOL rotation
timeFrame: 3 months postoperative
Secondary outcomes:
measure: Residual astigmatism after Ankoris implantation with respect to the targeted astigmatism correction.
timeFrame: Follow-ups will be performed 1 day, 1 month, and 3 months after cataract surgery
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Ruhr-Universitat Bochum, Bochum, Germany
Study officials:
affiliation: Ruhr-Universitat Bochum, Bochum, Germany
name: Burkhard Dick, MD
role: PRINCIPAL_INVESTIGATOR
References: