Comparison of Visual Outcomes After Implantation of the POD AY GF F (PhysIOL) and the POD AY 26P F (PhysIOL)

Study Overview
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Brief Summary
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The study is a prospective randomised controlled study. The patients get monolateral IOL implantation of POD F GF and POD F in the contralateral eye. Both IOLs are trifocal IOLs consisting of the same optical design. The difference between the IOLs is the material (hydrophilic and hydrophobic). To decide which eye receives POD F and which eye receives POD F GF, a randomization table will be provided to the principle investigator.

Detailed Description
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The examinations consist of visual acuity data, contrast sensitivity exams and slitlamp examinations. Follow up will be up to 6 months postoperative.

Official Title
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Comparison of Visual Outcomes After Implantation of the POD AY GF F (PhysIOL) and the POD AY 26P F (PhysIOL)

Conditions
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Cataract, Lens Opacity

Intervention / Treatment
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* Device: IOL implantation experimental
* Device: IOL implantation comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cataractous Eyes with no comorbidity Patient older than 50 years old Regular corneal astigmatism <0.75 dioptres by an automatic keratometer (regularity determined by the topography of the keratometry) or <1.0 dioptres if the steep axis of cylinder is between 90° and 120° 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 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)

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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IOL Implantation experimental<br>Implantation of POD F GF in one of the eyes of the study subject | Device: IOL implantation experimental<br>* Implantation of trifocal IOL POD F GF consisting of hydrophobic material<br>|
| Active Comparator: IOL Implantation Comparator<br>Implantation of POD F in the contralateral eye of the study subject | Device: IOL implantation comparator<br>* Implantation of trifocal IOL POD F consisting of hydrophilic material<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity at far, near and intermediate distance | ability to read letters at different distances | 6 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