Comparison of Visual Outcomes After Implantation of the Synthesis Plus and Synthesis Plus Toric
Recruiting
- Conditions
- CataractSurgeryIOL
- Interventions
- Device: Implantation of Synthesis Plus IOL (control device)Device: Implantation of Synthesis Plus Toric IOL (investigational device)
- Registration Number
- NCT05561478
- Lead Sponsor
- Cutting Edge SAS
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 72
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control device (Synthesis Plus) Implantation of Synthesis Plus IOL (control device) Requiring bilateral cataract surgery Test device (Synthesis Plus Toric) Implantation of Synthesis Plus Toric IOL (investigational device) Requiring bilateral cataract surgery with pre-existing astigmatism
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Monocular UIVA 1 month 66 cm
Monocular BCDVA 1 month distance
Rotational stability Peroperatively, day 0, Month 1 in degrees
Refraction 1 month subjective
Monocular DCIVA 1 month 66 cm
Monocular UDVA 1 month distance
Potential complications 1 month postoperative
Subjective quality of vision 1 month PROM
Trial Locations
- Locations (1)
VISIS
🇫🇷Perpignan, France