Comparison of Visual Outcomes After Implantation of the Synthesis Plus and Synthesis Plus Toric (DETPLUST)

Cutting Edge

Status: Enrolling

Conditions: Cataract; Surgery; IOL

Treatments: Device: Implantation of Synthesis Plus IOL (control device); Device: Implantation of Synthesis Plus Toric IOL (investigational device)

Study type: Observational

Funder types: Industry

Identifiers

NCT05561478

2021-A02415-36

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

72 participants in 2 patient groups

Test device (Synthesis Plus Toric)

Description:

Requiring bilateral cataract surgery with pre-existing astigmatism

Treatment:

Device: Implantation of Synthesis Plus Toric IOL (investigational device)

Control device (Synthesis Plus)

Description:

Requiring bilateral cataract surgery

Treatment:

Device: Implantation of Synthesis Plus IOL (control device)