Cataract, IOL, Surgery
Conditions
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.
Interventions
DEVICEImplantation of Synthesis Plus IOL (control device)
Synthesis Plus IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients.
DEVICEImplantation of Synthesis Plus Toric IOL (investigational device)
Synthesis Plus Toric IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients with pre-existing astigmatism.
Sponsors
Cutting Edge SAS
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Monocular BCDVA | 1 month | distance |
| Monocular UIVA | 1 month | 66 cm |
| Monocular DCIVA | 1 month | 66 cm |
| Monocular UDVA | 1 month | distance |
| Potential complications | 1 month | postoperative |
| Rotational stability | Peroperatively, day 0, Month 1 | in degrees |
| Subjective quality of vision | 1 month | PROM |
| Refraction | 1 month | subjective |
Countries
France
Contacts
Primary ContactLine Bettinelli, OD
Outcome results
None listed