Visual Performance, Patient Satisfaction and PCO Rate After Implantation of a Trifocal Hydrophobic IOL

Study Overview
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Brief Summary
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Prospective, controlled, single-surgeon, single-center post-market clinical follow up study to investigate the clinical outcomes of a hydrophobic trifocal IOL (PhysIOL POD F GF)

Detailed Description
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This clinical investigation is a prospective, controlled, single-surgeon, single-center post-market clinical follow up study whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses FineVision POD F GF (PhysIOL, Liège, Belgium). The study purpose is to obtain clinical data on visual acuity, contrast sensitivity, questionnaire outcomes and PCO rate on patients implanted with FineVision POD F GF. The device under investigation (FineVision POD F GF) is a trifocal glistening-free hydrophobic acrylic intraocular lens (IOL) manufactured by the sponsor of this study PhysIOL sa/nv. The IOL will be implanted as part of the routine cataract surgery on patients suffering from cataract development. In total 25 patients will be recruited for this clinical study and receive a bilateral implantation of FineVision POD F GF intraocular lens. Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 24 months.

Official Title
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Clinical Study to Investigate Visual Performance, Patient Satisfaction and PCO Rate After Implantation of a Trifocal Hydrophobic IOL

Conditions
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Cataract, Lens Opacities, Presbyopia

Intervention / Treatment
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* Device: IOL implantation experimental


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cataractous 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: Irregular astigmatism Age of patient < 45 years Regular corneal astigmatism >0.75 dioptres by an automatic keratometer or biometer or >1.0 dioptres if the steep axis of cylinder is between 90° and 120° in one or both eyes 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) AMD suspicious eyes (determined by OCT) Complicated surgery

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: IOL implantation experimental<br>hydrophobic, trifocal intraocular lens POD F GF | Device: IOL implantation experimental<br>* Implantation of trifocal IOL POD F GF consisting of hydrophobic material<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| binocular Uncorrected Distance Visual Acuity (UDVA) | Statistically significant equality between literature data and data obtained in this study on binocular UDVA. UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014 | 3 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Manifested refraction | The manifested refraction is measured by means of a phoropter. The data contains values for sphere, cylinder and axis of cylinder according to ISO 11979-7:2014. This data will also be used to calculate the manifested refractive spherical equivalent (MRSE) | 3 months postoperative | 
| Uncorrected Distance Visual Acuity (UDVA) | UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly. | 3 months postoperative | 
| Corrected Distance Visual Acuity (CDVA) | CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014. This assessment is done monocularly and binocularly. | 3 months postoperative | 
| Distance Corrected Intermediate Visual Acuity (DCIVA) | DCIVA is measured with ETDRS charts placed in 70cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly. | 3 months postoperative | 
| Uncorrected Intermediate Visual Acuity (UIVA) | UIVA is measured with ETDRS charts placed in 70cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly and binocularly. | 3 months postoperative | 
| Distance Corrected Near Visual Acuity (DCNVA) | DCNVA is measured with ETDRS charts placed in 35cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly. | 3 months postoperative | 
| Uncorrected Near Visual Acuity (UNVA) | UNVA is measured with ETDRS charts placed in 35cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly and binocularly. | 3 months postoperative | 
| Contrast Sensitivity | Contrast Sensitivity under photopic and mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision) | 3 months postoperative | 
| Aberrometry | Aberrometry outcomes are measured with a standard aberrometer. The following values will be evaluated in this study: Spherical aberrations, high order aberrations, lens tilt. | 3 months postoperative | 
| PCO rate | The rate of patients showing posterior capsular opacities (PCO) long term after surgery will be assessed. The criteria is, if the eye requires a secondary treatment to remove the PCO. | 2 years postoperative | 
| questionnaire | Outcomes measures of a questionnaire to address the general patient satisfaction and possible side effects of the treatment. For this study, the validated and verified questionnaire VFQ-25 (National Eye Institute) will be used. The maximum score for each question is 100. | 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, hydrophobic, hydrophilic