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

• Implantation of Synthesis Plus IOL (control device) (Device): Synthesis Plus IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients.
• Implantation of Synthesis Plus Toric IOL (investigational device) (Device): Synthesis Plus Toric IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients with pre-existing astigmatism.

Primary outcomes

• DCIVA at 66 cm [1 month]: 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

Secondary outcomes

• Monocular UDVA [1 month]: distance
• Monocular BCDVA [1 month]: distance
• Monocular UIVA [1 month]: 66 cm
• Monocular DCIVA [1 month]: 66 cm
• Refraction [1 month]: subjective
• Potential complications [1 month]: postoperative
• Rotational stability [Peroperatively, day 0, Month 1]: in degrees
• Subjective quality of vision [1 month]: PROM

Sex: All, ages: 50 Years to any

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

• Boris Dethinne, MD, Principal investigator, Visis