Overview
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.
Eligibility
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