Trials / Completed
CompletedNCT05538754
Post-Market Evaluation of the EVO ICL
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 205 (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 assess the rate of early intraocular pressure (IOP) increases following implantation of EVO/EVO+ Implantable Collamer Lens (ICL).
Detailed description
This study will be conducted at up to 10 sites in the US, by surgeons qualified by experience and training to implant the EVO/EVO+ lens.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | EVO ICL | The EVO ICL 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
- 2022-09-23
- Primary completion
- 2023-09-21
- Completion
- 2023-10-04
- First posted
- 2022-09-14
- Last updated
- 2026-03-05
- Results posted
- 2024-12-03
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05538754. Inclusion in this directory is not an endorsement.