Rotational Stability Analysis of a Toric Monofocal IOL

NCT ID: NCT04933487

Last Updated: 2021-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-26
• Study Completion Date: 2019-03-31

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.

Conditions

Cataract; Lens Opacities; Astigmatism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ankoris IOL Implantation experimental

Monolateral implantation of toric intraocular lenses Ankoris

Group Type: EXPERIMENTAL

IOL implantation experimental

Intervention Type: DEVICE

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

Interventions

IOL implantation experimental

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

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

targomedGmbH

INDUSTRY

Sponsor Role: collaborator

Beaver-Visitec International, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Burkhard Dick, MD

Role: PRINCIPAL_INVESTIGATOR

Ruhr-Universitat Bochum, Bochum, Germany

Locations

Ruhr-Universitat Bochum, Bochum, Germany

Bochum, , Germany

Countries

Germany

Other Identifiers

PHY2013

Identifier Type: -

Identifier Source: org_study_id