Rotational Stability Analysis of a Toric Monofocal IOL

Study Overview
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Brief Summary
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This is a single-center, prospective PMCF study whereby patients undergoing routine cataract surgery will have monolateral implantation of hydrophilic monofocal toric intraocular lens Ankoris.

Detailed Description
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This is a single-center, prospective, nonrandomized PMCF study whereby patients undergoing routine cataract surgery will have monolateral implantation of hydrophilic monofocal toric intraocular lens (Ankoris). The device under investigation is manufactured by the sponsor of this study. The refractive power of the lens has a spherical and a cylindrical component. The IOLs will be implanted in the course of routine cataract surgery and will benefit to patients suffering from cataract development and showing pre-existing corneal astigmatism. The primary objective of this study is to determine the rotational stability of the Ankoris intraocular lens. The secondary objective is to measure the residual astigmatism after Ankoris implantation with respect to the targeted astigmatism correction. In total approx. 20 eyes of 20 patients will be recruited for this clinical study. Follow-ups will be performed 1 day, 1 month, and 3 months after cataract surgery. Subjects would have the option for unscheduled visits if required medically.

Official Title
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Prospective Evaluation of the Rotational Stability of the Ankoris Intraocular Lens

Conditions
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Cataract, Lens Opacities, Astigmatism

Intervention / Treatment
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* Device: IOL implantation experimental


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cataracteous Eyes with no comorbidity Regular corneal astigmatism >1 dioptre and <3D determined by an automatic keratometer (regularity determined by the topography of the keratometry). Availability, willingness and sufficient cognitive awareness to comply with examination procedures Signed informed consent •>50 years old Exclusion Criteria: Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…) Any ocular comorbidity History of ocular trauma or prior ocular surgery including refractive procedures Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, Marfan's syndrome) Pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ankoris IOL Implantation experimental<br>Monolateral implantation of toric intraocular lenses Ankoris | Device: IOL implantation experimental<br>* Monolateral implantation of toric intraocular lenses Ankoris. (Manufactured by PhysIOL sa/nv, Liège, Belgium).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rotational stability - Photograph of IOL with dilated pupil to asses IOL rotation | Rotational stability of the ANKORIS is evaluated on the basis of slit-lamp photographies to capture the iris and the marks onto the lens. Descriptive statistics will be used to determine the IOL stability. | 3 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual astigmatism after Ankoris implantation with respect to the targeted astigmatism correction. | Visual performance is determined in terms of monocular uncorrected distance visual acuity (UDVA), distance corrected visual acuity (DCVA) and postoperative refraction. Efficiency will be assessed using Alpins method. | Follow-ups will be performed 1 day, 1 month, and 3 months after cataract surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraocular Lens, Monofocal, Toric Lens