Trials / Completed
CompletedNCT03500198
Clinical Investigation of the Next Generation Intraocular Lens
Clinical Investigation of the Safety and Effectiveness of the Next-Generation TECNIS® Symfony® Intraocular Lens Model ZHR00
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 247 (actual)
- Sponsor
- Johnson & Johnson Surgical Vision, Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Accepted
Summary
An investigational IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month study.
Detailed description
The next generation TECNIS IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month interventional study and compared to a marketed monofocal IOL. Assessments included distance-corrected intermediate and near visual acuity, depth of focus at 0.2 logMAR and spectacle wear frequency.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL | Intraocular lens replaces the natural lens removed during cataract surgery. |
| DEVICE | Control Monofocal Intraocular Lens: TECNIS Monofocal IOL | Intraocular lens replaces the natural lens removed during cataract surgery. |
Timeline
- Start date
- 2018-06-28
- Primary completion
- 2019-06-05
- Completion
- 2019-06-05
- First posted
- 2018-04-18
- Last updated
- 2020-06-25
- Results posted
- 2020-06-25
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03500198. Inclusion in this directory is not an endorsement.