Rotational Stability Analysis of a Toric Monofocal IOL (PHY2013)

Prospective Evaluation of the Rotational Stability of the Ankoris Intraocular Lens

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.

Study Overview

• Status: Completed
• Conditions: Cataract; Astigmatism; Lens Opacities
• Intervention / Treatment: Device: IOL implantation experimental

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bochum, Germany
    • Ruhr-Universitat Bochum, Bochum, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ankoris IOL Implantation experimental; Monolateral implantation of toric intraocular lenses Ankoris	Device: IOL implantation experimental; Monolateral implantation of toric intraocular lenses Ankoris. (Manufactured by PhysIOL sa/nv, Liège, Belgium).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Follow-ups will be performed 1 day, 1 month, and 3 months after cataract surgery

Collaborators and Investigators

• Sponsor: Beaver-Visitec International, Inc.
• Collaborators: targomedGmbH
• Investigators: Principal Investigator: Burkhard Dick, MD, Ruhr-Universitat Bochum, Bochum, Germany

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: June 18, 2021
• First Submitted That Met QC Criteria: June 18, 2021
• First Posted (Actual): June 21, 2021

Study Record Updates

• Last Update Posted (Actual): June 21, 2021
• Last Update Submitted That Met QC Criteria: June 18, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Intraocular Lens; Monofocal; Toric Lens
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Astigmatism
• Other Study ID Numbers: PHY2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No