A-constant Optimization of a Toric Monofocal IOL

June 25, 2021 updated by: Beaver-Visitec International, Inc.

Optimization of the Optical Constants of the PhysIOL ANKORIS Intraocular Lens

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium
        • Guy Sallet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pseudophakic patients implanted with one of the two IOLs

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients implanted with Ankoris IOL
To assess the IOL stability, slitlamp photos of the consecutive 30 patients with respect to time will then be analysed with a 5% confidence interval.
Device: Ankoris
Implantations of test lens using standard phaco surgical technique, with aim for in-the-bag implantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1-2 hours
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.
1 month
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rotational stability
Time Frame: 1-2 hours
To measure the residual astigmatism after Ankoris IOL implantation with respect to the targeted astigmatism correction.
1-2 hours
Rotational stability
Time Frame: 1 month
To measure the residual astigmatism after Ankoris IOL implantation with respect to the targeted astigmatism correction.
1 month
Rotational stability
Time Frame: 3 months
To measure the residual astigmatism after Ankoris IOL implantation with respect to the targeted astigmatism correction.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beaver-Visitec International, Inc.

Investigators

  • Principal Investigator: Guy Sallet, MD, Private Eye Institue Aalst, Belgium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 3, 2014

Primary Completion (ACTUAL)

March 19, 2018

Study Completion (ACTUAL)

June 11, 2019

Study Registration Dates

First Submitted

June 18, 2021

First Submitted That Met QC Criteria

June 25, 2021

First Posted (ACTUAL)

June 29, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 29, 2021

Last Update Submitted That Met QC Criteria

June 25, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHY2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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