Clinical Trial With PRECIZON Presbyopic

Study Overview
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Brief Summary
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The purpose of this clinical trial is to evaluate the effectiveness of the PRECIZON Presbyopic.

Detailed Description
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Prospective, open-label, single-arm, multicenter clinical evaluation with a 3 months follow-up. The PRECIZON Presbyopic is a lens intended for implantation in the capsular bag, indicated for optical correction of aphakia in adults whom the crystalline lens has been removed and who desire presbyopia correction. The main objective is to evaluate the ability of the PRECIZON Presbyopic to provide near, intermediate and distance vision in patients undergoing cataract extraction / Clear Lens Exchange (CLE) and intraocular lens implantation. Study results will be used for CE-approval and registration and marketing purposes.

Official Title
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Prospective Multicenter Clinical Trial With the PRECIZON Presbyopic Multifocal Intraocular Lens

Conditions
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Cataract, Presbyopia

Intervention / Treatment
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* Device: PRECIZON Presbyopic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presbyopic Cataract patient or Clear Lens Extraction (CLE) candidate Patients wishes to be spectacle independent for near and far vision Patient lifestyle and outlook fit with multifocal IOL implantation Qualifies for bilateral implantation Patient must have a calculated IOL power within the available diopter range Expected best corrected visual acuity of 0.5 Snellen decimal or better after IOL implantation. No secondary surgical procedure planned during the course of the study Availability, willingness and sufficient cognitive awareness and physical ability to comply with examination procedures throughout the entire duration of the study Patients must provide written informed consent The predicted keratometric postoperative astigmatism (calculated with respect to the surgical induced astigmatism) must be <1.0 D. Exclusion Criteria: Ocular disease other than cataract that may predispose for future complications or might confound the outcome of the investigation (e.g. anterior segment pathology, glaucoma, corneal dystrophy, ocular inflammation, pseudoexfoliation syndrome, retinal disorders) Acute or chronic disease or illness or use of medication that could confound the outcome of the study or increase the risk to the subject Endothelial cell count <1500 cells/mm2 Amblyopia Congenital eye abnormalities Previous ocular surgery that might confound the outcome of the investigation or increase risk to patient Concurrent participation or participation during the last 30 days in any other clinical trial Patient must not be pregnant or has another condition with associated fluctuation of hormones that could lead to refractive changes

Ages Eligible for Study
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Minimum Age: 45 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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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Bilateral implantation with PRECIZON Presbyopic intraocular lens | Device: PRECIZON Presbyopic<br>* Optical correction of aphakia in adults in whom the crystalline lens has been removed and who desire presbyopia correction.<br>* Other names: PRECIZON Presbyopic Multifocal intraocular lens (MIOL);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in monocular and binocular uncorrected and corrected near visual acuity | The ability of the PRECIZON Presbyopia Intraocular lens (IOL) to provide near visual acuity | 3 months follow-up postoperative | 
| Improvement in monocular and binocular uncorrected and corrected intermediate visual acuity | The ability of the PRECIZON Presbyopia Intraocular lens (IOL) to provide intermediate visual acuity | 3 months post-op | 
| Improvement in monocular and binocular uncorrected and corrected distance visual acuity | The ability of the PRECIZON Presbyopia Intraocular lens (IOL) to provide distance visual acuity | 3 months post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photopic contrast sensitivity as measured by a contrast sensitivity chart | Binocular contrast sensitivity scores for spatial frequencies of 3.0 cpd, 6.0 cpd, 12.0 cpd and 18.0 cpd. | 3 months postoperative | 
| Mesopic contrast sensitivity as measured by a contrast sensitivity chart | Binocular contrast sensitivity scores for spatial frequencies of 3.0 cpd, 6.0 cpd, 12.0 cpd and 18.0 cpd. | 3 months post-op | 
| Stability of manifest refraction (MRSE) as measured by a mean change in MRSE between visits as determined by a paired analysis | Percentage of eyes that achieve a change of less than or equal to 1.00 D of MRSE between two refractions performed 3 months apart | 3 months post-op | 
| Spectacle dependency | Percentage of patients that achieve complete spectacle independence or occasional use of glasses for near or intermediate vision | 3 months post-op | 
| Defocus curve | Binocular defocus evaluation will be obtained by using the best corrected distance refraction and then defocusing the image in 0.5 D increments to -0.5 D. | 3 months post-op | 
| Rates of adverse events and complications |  | 3 months post-op | 
| Patient satisfaction as measured by a patient satisfaction questionnaire |  | 3 months post-op | 
| Quality of vision as measured by the Quality of Vision (QoV) questionnaire | Percentage of patients with a QoV score >10 and >30 at 3 months postoperative | 3 months post-op |