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

NCT ID: NCT05561478

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-10
• Study Completion Date: 2025-10-31

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.

Conditions

Cataract; Surgery; IOL

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Test device (Synthesis Plus Toric)

Requiring bilateral cataract surgery with pre-existing astigmatism

Implantation of Synthesis Plus Toric IOL (investigational device)

Intervention Type: DEVICE

Synthesis Plus Toric IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients with pre-existing astigmatism.

Control device (Synthesis Plus)

Requiring bilateral cataract surgery

Implantation of Synthesis Plus IOL (control device)

Intervention Type: DEVICE

Synthesis Plus IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients.

Interventions

Implantation of Synthesis Plus IOL (control device)

Synthesis Plus IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients.

Intervention Type: DEVICE

Implantation 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cutting Edge SAS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boris Dethinne, MD

Role: PRINCIPAL_INVESTIGATOR

Visis

Locations

VISIS

Perpignan, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Line Bettinelli, OD

Role: CONTACT

line.bettinelli@cutting-edge.fr

0619530701

Facility Contacts

Boris DETHINNE, MD

Role: primary

Other Identifiers

2021-A02415-36

Identifier Type: -

Identifier Source: org_study_id