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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
VISIS
RECRUITING
Perpignan
Contact Information
Primary
Line Bettinelli, OD
line.bettinelli@cutting-edge.fr
0619530701
Time Frame
Start Date: 2022-10-10
Estimated Completion Date: 2025-10
Participants
Target number of participants: 72
Treatments
Test device (Synthesis Plus Toric)
Requiring bilateral cataract surgery with pre-existing astigmatism
Control device (Synthesis Plus)
Requiring bilateral cataract surgery
Related Therapeutic Areas
Sponsors
Leads: Cutting Edge SAS

This content was sourced from clinicaltrials.gov