Rotational Stability Analysis of a Toric Monofocal IOL

Not Applicable

Completed

• Conditions: Lens Opacities; Cataract; Astigmatism
• Interventions: Device: IOL implantation experimental

• Registration Number: NCT04933487
• Lead Sponsor: Beaver-Visitec International, Inc.

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.

Study Timeline

• Study Start: 2014-08-26
• Primary Completion: 2016-01-01
• Study Completion: 2019-03
• Status Verified: 2021-06
• Study First Submitted: 2021-06-18
• Study First Submitted QC: 2021-06-18
• Last Update Submitted: 2021-06-18
• Study First Posted: 2021-06-21
• Last Update Posted: 2021-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ankoris IOL Implantation experimental	IOL implantation experimental	Monolateral implantation of toric intraocular lenses Ankoris

Primary Outcome Measures

Name	Time	Method
Rotational stability - Photograph of IOL with dilated pupil to asses IOL rotation	3 months postoperative	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.

Secondary Outcome Measures

Name	Time	Method
Residual astigmatism after Ankoris implantation with respect to the targeted astigmatism correction.	Follow-ups will be performed 1 day, 1 month, and 3 months after cataract surgery	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.

Trial Locations

Locations (1)

Ruhr-Universitat Bochum, Bochum, Germany; 🇩🇪 Bochum, Germany