A-constant Optimization of a Toric Monofocal IOL

Optimization of the Optical Constants of the PhysIOL ANKORIS Intraocular Lens

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04944238

Enrollment

Registered

2021-06-29

Start date

2014-11-03

Completion date

2019-06-11

Last updated

2021-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Brief 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.

Interventions

DEVICEAnkoris

Implantations of test lens using standard phaco surgical technique, with aim for in-the-bag implantation.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Patient older than 50 years old * Age-related cataract * Corneal astigmatisme \>1 D * Age 21 and older * Visual Acuity \> 0.05 * Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.

Exclusion criteria

* Relevant other ophthalmic diseases such as pseudoexfoliation syndrome, floppy iris syndrome, corneal pathologies * Previous ocular surgery or trauma.

Design outcomes

Primary

Measure	Time frame	Description
The principal objective of the study is to determine the IOL constant.	1-2 hours	IOL constant optimisation for PCI axial length measurement of Physiol Ankoris IOL.

Secondary

Measure	Time frame	Description
Rotational stability	1-2 hours	To measure the residual astigmatism after Ankoris IOL implantation with respect to the targeted astigmatism correction.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026