A-constant Optimization of a Toric Monofocal IOL

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

Detailed Description
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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.

Official Title
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Optimization of the Optical Constants of the PhysIOL ANKORIS Intraocular Lens

Conditions
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Cataract

Intervention / Treatment
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* Device: Ankoris


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients implanted with Ankoris IOL<br>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<br>* Implantations of test lens using standard phaco surgical technique, with aim for in-the-bag implantation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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