Phase
Condition
Surgery
Eye Disorders/infections
Vision Loss
Treatment
Implantation of Synthesis Plus Toric IOL (investigational device)
Implantation of Synthesis Plus IOL (control device)
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 regularitydetermined by the topography) for patients implanted with SYNTHESIS PLUS TORIC orRegular corneal astigmatism lower or equal to 0.5 D dioptres by MS-39 (SimKkeratometry and regularity determined by the topography) for patients implanted withSYNTHESIS 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 withexamination procedures
Non inclusion Criteria:
Patients with a potential postoperative visual acuity of less than 5/10, inparticular due to degenerative visual disorders, poor retinal function or a damagedcornea.
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 studyresults (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucomaetc...)
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 ofthe lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
Patients with chronic uveitis
Pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupilsthat do not dilate under mesopic/scotopic conditions, diameter (pupil>4mm or <2.5 mmin photopic conditions))
Narrow anterior chambers (ACD ≤ 2.5 mm)
Any corneal pathology potentially affecting the topography (eg. Keratoconus),
Monophthalma patients
Phacodonesis
Exclusion
Exclusion criteria:
Complicated surgery
Inability to place the intraocular lens safely at the location planned
Subjects with zonular laxity
Postoperative endophthalmitis
Study Design
Connect with a study center
VISIS
Perpignan, 66000
FranceActive - Recruiting
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