A-constant Optimization of a Toric Monofocal IOL

NCT ID: NCT04944238

Last Updated: 2021-06-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 78 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-03
• Study Completion Date: 2019-06-11

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.

Conditions

Cataract

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Ankoris

Intervention Type: DEVICE

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

Interventions

Ankoris

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beaver-Visitec International, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guy Sallet, MD

Role: PRINCIPAL_INVESTIGATOR

Private Eye Institue Aalst, Belgium

Locations

Guy Sallet

Aalst, , Belgium

Countries

Belgium

Other Identifiers

PHY2014

Identifier Type: -

Identifier Source: org_study_id