A-constant Optimization of a Toric Monofocal IOL

Completed

• Conditions: Cataract

• Registration Number: NCT04944238
• Lead Sponsor: Beaver-Visitec International, Inc.

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.

Study Timeline

• Study Start: 2014-11-03
• Primary Completion: 2018-03-19
• Study Completion: 2019-06-11
• Status Verified: 2021-06
• Study First Submitted: 2021-06-18
• Study First Submitted QC: 2021-06-25
• Last Update Submitted: 2021-06-25
• Study First Posted: 2021-06-29
• Last Update Posted: 2021-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The principal objective of the study is to determine the IOL constant.	3 months	IOL constant optimisation for PCI axial length measurement of Physiol Ankoris IOL.

Secondary Outcome Measures

Name	Time	Method
Rotational stability	3 months	To measure the residual astigmatism after Ankoris IOL implantation with respect to the targeted astigmatism correction.

Trial Locations

Locations (1)

Guy Sallet; 🇧🇪 Aalst, Belgium