Trials / Recruiting
RecruitingNCT05561478
Comparison of Visual Outcomes After Implantation of the Synthesis Plus and Synthesis Plus Toric
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 72 (estimated)
- Sponsor
- Cutting Edge SAS · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Implantation of Synthesis Plus IOL (control device) | Synthesis Plus IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients. |
| 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. |
Timeline
- Start date
- 2022-10-10
- Primary completion
- 2025-08-01
- Completion
- 2025-10-01
- First posted
- 2022-09-30
- Last updated
- 2025-02-11
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05561478. Inclusion in this directory is not an endorsement.