NCT04944238

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 3, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 29, 2021

Completed
Last Updated

June 29, 2021

Status Verified

June 1, 2021

Enrollment Period

3.4 years

First QC Date

June 18, 2021

Last Update Submit

June 25, 2021

Conditions

Cataract

Outcome Measures

Primary Outcomes (3)

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

    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.

    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.

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

    3 months

Secondary Outcomes (3)

  • Rotational stability

    1-2 hours

  • Rotational stability

    1 month

  • Rotational stability

    3 months

Study Arms (1)

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

Interventions

AnkorisDEVICE

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

Patients implanted with Ankoris IOL

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pseudophakic patients implanted with one of the two IOLs

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy Sallet

Aalst, Belgium

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Guy Sallet, MD

    Private Eye Institue Aalst, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2021

First Posted

June 29, 2021

Study Start

November 3, 2014

Primary Completion

March 19, 2018

Study Completion

June 11, 2019

Last Updated

June 29, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)