Trials / Completed
CompletedNCT04516772
STAAR Visian Toric ICL Post-Approval Study
Post-Approval Study of the Visian Toric Implantable Collamer Lens
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 125 (actual)
- Sponsor
- Staar Surgical Company · Industry
- Sex
- All
- Age
- 21 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate the long term (i.e. 24 months) clinical performance of the Visian® Toric Implantable Collamer® Lens (ICL).
Detailed description
This study will be conducted at 6-8 clinical sites in the US, by surgeons qualified by experience and training to implant Visian Toric ICLs.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Visian TICL | The Visian TICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. |
Timeline
- Start date
- 2020-07-21
- Primary completion
- 2024-12-11
- Completion
- 2024-12-11
- First posted
- 2020-08-18
- Last updated
- 2026-03-13
- Results posted
- 2026-03-13
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04516772. Inclusion in this directory is not an endorsement.