Trials / Completed
CompletedNCT04176965
Investigation of the Safety and Effectiveness of a Trifocal IOL
Clinical Investigation of the Safety and Effectiveness of FINEVISION HP Trifocal IOL
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 539 (actual)
- Sponsor
- Beaver-Visitec International, Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
This study is a prospective, multicenter, randomized, double masked confirmatory trial comparing an investigational trifocal intraocular lens (IOL) and a commercially available monofocal IOL.
Detailed description
The study will include adult subjects with operable cataracts in both eyes who are eligible for phacoemulsification cataract surgery followed by IOL implantation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | FINEVISION HP IOL | Cataractous lens will be removed in the study eyes and the FINEVISION HP IOL will be implanted in the capsular bag. |
| DEVICE | Alcon AcrySof SN60AT | Cataractous lens will be removed in the study eyes and the Alcon AcrySof SN60AT IOL will be implanted in the capsular bag. |
Timeline
- Start date
- 2022-04-28
- Primary completion
- 2024-05-13
- Completion
- 2024-05-13
- First posted
- 2019-11-26
- Last updated
- 2025-01-29
- Results posted
- 2025-01-29
Locations
20 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04176965. Inclusion in this directory is not an endorsement.