NCT04944238

A-constant Optimization of a Toric Monofocal IOL

Optimization of the Optical Constants of the PhysIOL ANKORIS Intraocular Lens

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 78 (actual)
• Sponsor: Beaver-Visitec International, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

The study is a prospective series study to determine the IOL constant of a hydrophilic toric monofocal intra-ocular lens (IOL)

Detailed description

The study is a prospective series study with he principal objective to determine the IOL constant. The secondary objectives of this study are to determine the rotational stability of the Ankoris intraocular lens and to measure the residual astigmatism after Ankoris IOL implantation with respect to the targeted astigmatism correction. Although there may be no direct benefit to the subjects under study, the investigation will determined the optimized constant for accurate IOL power calculation and will assess the stability and efficacy of the toric optics: this would result in a benefit for the patient population. Since the material, the overall design of the IOL as well as the measuring procedure in this study is well tolerated in standard clinical practice and the IOL is readily available and CE-marked, the benefit/risk ratio appears acceptable.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	Ankoris	Implantations of test lens using standard phaco surgical technique, with aim for in-the-bag implantation.

Timeline

• Start date: 2014-11-03
• Primary completion: 2018-03-19
• Completion: 2019-06-11
• First posted: 2021-06-29
• Last updated: 2021-06-29

Locations

1 site across 1 country: Belgium