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