Comparison of Visual Outcomes After Implantation of the Synthesis Plus and Synthesis Plus Toric

Study Overview
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Brief Summary
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Prospective controlled monocentric study to determine the non-inferiority of the distance-corrected intermediate visual acuity at 66 cm of the SYNTHESIS PLUS TORIC with respect to the SYNTHESIS PLUS IOL.

Official Title
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Comparison of Visual Outcomes After Implantation of the Synthesis Plus and Synthesis Plus Toric

Conditions
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Cataract, Surgery, IOL

Intervention / Treatment
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* Device: Implantation of Synthesis Plus IOL (control device)
* Device: Implantation of Synthesis Plus Toric IOL (investigational device)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient older than 50 years old Patient requiring bilateral cataract surgery Regular corneal astigmatism >0.5D measured by MS-39 (SimK keratometry and regularity determined by the topography) for patients implanted with SYNTHESIS PLUS TORIC or Regular corneal astigmatism lower or equal to 0.5 D dioptres by MS-39 (SimK keratometry and regularity determined by the topography) for patients implanted with SYNTHESIS PLUS. Expected postoperative astigmatism ≤ 0.75D diopter Corneal astigmatism ≤4D IOL spherical equivalent power requested between 15D and 25D Signed informed consent Availability, willingness and sufficient cognitive awareness to comply with examination procedures Non inclusion Criteria: Patients with a potential postoperative visual acuity of less than 5/10, in particular due to degenerative visual disorders, poor retinal function or a damaged cornea. Amblyopia with a visual acuity potential of less than 5/10 IOL power needed outside the spherical equivalent diopter range: 15 to 25D 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…) Irregular astigmatism Subject with postoperative astigmatism, expected > 0.75 D. 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) Patients with chronic uveitis Pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions, diameter (pupil>4mm or <2.5 mm in photopic conditions)) Narrow anterior chambers (ACD ≤ 2.5 mm) Any corneal pathology potentially affecting the topography (eg. Keratoconus), Monophthalma patients Phacodonesis Exclusion criteria: Complicated surgery Inability to place the intraocular lens safely at the location planned Subjects with zonular laxity Postoperative endophthalmitis

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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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Test device (Synthesis Plus Toric)<br>Requiring bilateral cataract surgery with pre-existing astigmatism | Device: Implantation of Synthesis Plus Toric IOL (investigational device)<br>* Synthesis Plus Toric IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients with pre-existing astigmatism.<br>|
| Control device (Synthesis Plus)<br>Requiring bilateral cataract surgery | Device: Implantation of Synthesis Plus IOL (control device)<br>* Synthesis Plus IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DCIVA at 66 cm | The primary objective of this study is to determine the non-inferiority of the distance-corrected intermediate visual acuity at 66 cm of the SYNTHESIS PLUS TORIC with respect to the SYNTHESIS PLUS | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular UDVA | distance | 1 month | 
| Monocular BCDVA | distance | 1 month | 
| Monocular UIVA | 66 cm | 1 month | 
| Monocular DCIVA | 66 cm | 1 month | 
| Refraction | subjective | 1 month | 
| Potential complications | postoperative | 1 month | 
| Rotational stability | in degrees | Peroperatively, day 0, Month 1 | 
| Subjective quality of vision | PROM | 1 month |