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OpenTrials
Completed

NCT Number: NCT04944238

A-constant Optimization of a Toric Monofocal IOL

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

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Guy Sallet

Aalst, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ankoris

Device

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

Primary outcomes

  1. The principal objective of the study is to determine the IOL constant.

    Time frame: 1-2 hours

    IOL constant optimisation for PCI axial length measurement of Physiol Ankoris IOL.

  2. The principal objective of the study is to determine the IOL constant.

    Time frame: 1 month

    IOL constant optimisation for PCI axial length measurement of Physiol Ankoris IOL.

  3. The principal objective of the study is to determine the IOL constant.

    Time frame: 3 months

    IOL constant optimisation for PCI axial length measurement of Physiol Ankoris IOL.

Secondary outcomes

  1. Rotational stability

    Time frame: 1-2 hours

    To measure the residual astigmatism after Ankoris IOL implantation with respect to the targeted astigmatism correction.

  2. Rotational stability

    Time frame: 1 month

    To measure the residual astigmatism after Ankoris IOL implantation with respect to the targeted astigmatism correction.

  3. Rotational stability

    Time frame: 3 months

    To measure the residual astigmatism after Ankoris IOL implantation with respect to the targeted astigmatism correction.

Sponsors and collaborators

Lead sponsor

Beaver-Visitec International, Inc.

Industry

Registry information

Official study title

Optimization of the Optical Constants of the PhysIOL ANKORIS Intraocular Lens

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Jun 29, 2021
Registry last updated
Jun 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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