A-constant Optimization of a Toric Monofocal IOL

Cataract Clinical Trial

Official title:

Optimization of the Optical Constants of the PhysIOL ANKORIS Intraocular Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04944238
• Other study ID #: PHY2014
• Status: Completed
• Start date: November 3, 2014
• Est. completion date: June 11, 2019

Study information

• Verified date: June 2021
• Source: Beaver-Visitec International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: June 11, 2019
• Est. primary completion date: March 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

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

Locations

Country	Name	City	State
Belgium	Guy Sallet	Aalst

Sponsors (1)

Lead Sponsor	Collaborator
Beaver-Visitec International, Inc.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Rotational stability	To measure the residual astigmatism after Ankoris IOL implantation with respect to the targeted astigmatism correction.	1-2 hours
Secondary	Rotational stability	To measure the residual astigmatism after Ankoris IOL implantation with respect to the targeted astigmatism correction.	1 month
Secondary	Rotational stability	To measure the residual astigmatism after Ankoris IOL implantation with respect to the targeted astigmatism correction.	3 months