Rotation of Hydrophobic Acrylic Lenses - Rayner RA0800C & Alcon Clareon & Hoya Nanex & Hoya Vivinex XY1-EM & RayOne EMV Toric

Study Overview
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Brief Summary
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The investigational devices are approved intraocular lenses (IOL) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Within the study, three different IOLs will be investigated and separately evaluated. Cataract surgery with IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be postoperative refraction, visual acuity, slitlamp examination, and rotation of the IOL within 1 hour, 1 week, 1 month and 4-7 months. In the Alcon Clareon toric and RayOne EMV toric groups, patients receive a toric IOL according to their preoperative astigmatism

Official Title
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Rotation of Hydrophobic Acrylic Lenses - Rayner RA0800C & Alcon Clareon & Hoya Nanex & Hoya Vivinex XY1-EM & RayOne EMV Toric

Conditions
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Age Related Cataracts, Astigmatism

Intervention / Treatment
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* Device: Intraocular Lens Implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Uni- or bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation Age: 45 to 95 Need for spherical IOL correction between 10.00 and 30.00 D Need for spherical IOL correction between +6.00 and +30.00 D (Alcon Clareon toric group) Need for spherical IOL correction between +10.00 and +25.00 D (Rayner RayOne EMV toric group) Preoperative pupil dilation in mydriasis ≥ 7.0 mm (Hoya, Rayner groups) Astigmatism of at least 1.0 Diopters (Alcon Clareon toric and Rayner RayOne EMV toric groups) Pupil dilation >5.5mm (Alcon Clareon toric Rayner RayOne EMV toric group) Exclusion Criteria: Preceding ocular surgery or trauma Recurrent intraocular inflammation of unknown etiology Uncontrolled glaucoma Uncontrolled systemic or ocular disease Blind fellow eye Microphthalmus Corneal abnormality (Corneal scaring) History of uveitis/iritis Iris neovascularization Proliferative diabetic retinopathy Pregnancy Lactation Females of childbearing age will be asked if pregnancy is possible

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 95 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study involves 5 different groups. All groups will be investigated seperately. Alcon Clareon toric group: 130 eyes Rayner RayOne group: 130 eyes Hoya Nanex group: 130 eyes Hoya Vivinex Impress: 120 eyes Rayner RayOne EMV toric group: 120 eyes
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0°<br>Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 0° | Device: Intraocular Lens Implantation<br>* Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impressinto the capsular bag using an injector, after removing of the human cristalline lens. Implantation of the Alcon Clareon toric and Rayner RayOne EMV toric IOL on the axis according to the steep meridian of the cornea<br>|
| Experimental: 45°<br>Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 45° | Device: Intraocular Lens Implantation<br>* Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impressinto the capsular bag using an injector, after removing of the human cristalline lens. Implantation of the Alcon Clareon toric and Rayner RayOne EMV toric IOL on the axis according to the steep meridian of the cornea<br>|
| Experimental: 90°<br>Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 90° | Device: Intraocular Lens Implantation<br>* Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impressinto the capsular bag using an injector, after removing of the human cristalline lens. Implantation of the Alcon Clareon toric and Rayner RayOne EMV toric IOL on the axis according to the steep meridian of the cornea<br>|
| Experimental: 135°<br>Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 135° | Device: Intraocular Lens Implantation<br>* Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impressinto the capsular bag using an injector, after removing of the human cristalline lens. Implantation of the Alcon Clareon toric and Rayner RayOne EMV toric IOL on the axis according to the steep meridian of the cornea<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of axial intraocular lens position | Change in axis position of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon toric or Rayner RayOne EMV toric from end of surgery (baseline axis) to 1 hour, 1 week, 1 month and 4-7 months (end of study visit). The change in axis position will be evaluated with respect to the baseline measurement at the end of surgery. Differences in axis position will be described as rotation in degrees (0 to 360°) | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decentration | Decentration of the intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon toric or Rayner RayOne EMV toric will be measured with the Casia 2 OCT. Decentration will be described as Decentration in milimeter | 7 months | 
| Tilt | Tilt of the intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon toric or Rayner RayOne EMV toric will be measured with the Casia 2 OCT. Tilt will be described as Tilt in degrees at a certain axis | 7 months | 
| Anterior chamber depth | The anterior chamber depth (Axial position of the IOL) of the intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon or Rayner RayOne EMV toric will be measured with the Casia 2 OCT after 1 month. The anterior chamber depth will be measured in milimeter | 1 month | 
| Best corrected visual acuity (BCVA) | BCVA will be measured at 1 week, 1 month and 4 to 7 months. The BCVA will be described as the minimum angle of resolution (logMar) | 7 months | 
| UCIVA in the Alcon Clareon toric and Rayner RayOne EMV toric groups | Uncorrected Intermediate Visual Acuity mono or bilateral | 7 months |