Rotational Stability Analysis of a Toric Monofocal IOL

Beaver-Visitec International, Inc.23 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cataract Lens Opacities Astigmatism

Interventions

IOL implantation experimentalDEVICE

Monolateral implantation of toric intraocular lenses Ankoris. (Manufactured by PhysIOL sa/nv, Liège, Belgium).

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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)

Locations (1)

Ruhr-Universitat Bochum, Bochum, Germany

Bochum, Germany

Outcomes

Primary Outcomes

Rotational stability - Photograph of IOL with dilated pupil to asses IOL rotation

Rotational stability of the ANKORIS is evaluated on the basis of slit-lamp photographies to capture the iris and the marks onto the lens. Descriptive statistics will be used to determine the IOL stability.

Time frame: 3 months postoperative

Secondary Outcomes

Residual astigmatism after Ankoris implantation with respect to the targeted astigmatism correction.

Visual performance is determined in terms of monocular uncorrected distance visual acuity (UDVA), distance corrected visual acuity (DCVA) and postoperative refraction. Efficiency will be assessed using Alpins method.

Time frame: Follow-ups will be performed 1 day, 1 month, and 3 months after cataract surgery

Data from ClinicalTrials.gov

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