Clinical Study to Investigate Visual Performance of IOL: FineVision HP

Study Overview
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Brief Summary
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This is a prospective, non-randomised, controlled, single-surgeon, single-center post-market clinical follow up study whereby patient undergoing routine cataract surgery will have bilateral implantation of a recently introduced TGA (Therapeutics Goods Authority, Australia) approved trifocal intraocular lens FineVision Evo (PhysIOL, Liège, Belgium). The primary and secondary effectiveness data for visual acuity, defocus curves, contrast sensitivity and any adverse events will be collected.

Detailed Description
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Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 3 months, same as the surgeon's standard follow up protocol for bilateral cataract surgery with IOL implantation. Subjects would have the option for unscheduled visits if required medically. Primary endpoint data will be collected at the final visit. Data analyses will be done in the end to support the study publication plan.

Official Title
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Clinical Study to Investigate Visual Performance of Hydrophobic Trifocal IOL: FineVision HP

Conditions
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Cataract, Lens Opacity

Intervention / Treatment
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* Device: Implantation of IOL: PhysIOL POD F GF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cataracteous eyes with no comorbidity Spontaneously emitting the desire for spectacle independence after surgery and with realistic expectation. Availability, willingness and sufficient cognitive awareness to comply with examination procedures Signed informed consent Exclusion Criteria: Unrealistic expectation Irregular astigmatism Regular corneal astigmatism >0.75 D on one or both eyes as measured by an automatic keratometer (regularity determined by the topography of the keratometry) Difficulty for cooperation (distance from their home, general health condition) 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, chronic Uveitis, Marfan's syndrome) Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions) Complicated surgery

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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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IOL Implantation<br>Implantation of IOL: PhysIOL POD F GF | Device: Implantation of IOL: PhysIOL POD F GF<br>* Implantation of trifocal IOL POD F GF consisting of hydrophobic material<br>* Other names: PhysIOL HP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| binocular Distance Corrected Near Visual Acuity (DCNVA) | measured in logMAR | 3 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| monocular and binocular Uncorrected Distance Visual Acuity (UDVA) | measured in logMAR | 3 months postoperative | 
| monocular and binocular Corrected Distance Visual Acuity (CDVA) | measured in logMAR | 3 months postoperative | 
| monocular and binocular Uncorrected Intermediate Visual Acuity (UIVA) | measured in logMAR | 3 months postoperative | 
| monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA) | measured in logMAR | 3 months postoperative | 
| monocular and binocular Uncorrected Near Visual Acuity (UNVA) | measured in logMAR | 3 months postoperative | 
| monocular and binocular Distance Corrected Near Visual Acuity (DCNVA) | measured in logMAR | 3 months postoperative | 
| Contrast Sensitivity (mesopic and photopic) | measured in logCS | 3 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraocular Lens, trifocal, cataract, PhysIOL