Trials / Terminated
TerminatedNCT05574959
Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens, Model DEN00V
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 243 (actual)
- Sponsor
- Johnson & Johnson Surgical Vision, Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, multicenter, bilateral, masked (sponsor, subject and evaluator), randomized clinical trial to evaluate the safety and effectiveness of the TECNIS IOL, Model DEN00V in comparison to an aspheric monofocal IOL.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | investigational IOL Model DEN00V | Eligible subjects will be randomized in a 1:1 ratio to receive the investigational IOL Model DEN00V in both eyes for the duration of the study. |
| DEVICE | control IOL Model ZCB00/DCB00 | Eligible subjects will be randomized in a 1:1 ratio to receive the control IOL Model ZCB00/DCB00 in both eyes for the duration of the study. |
Timeline
- Start date
- 2022-10-24
- Primary completion
- 2023-10-24
- Completion
- 2023-10-24
- First posted
- 2022-10-12
- Last updated
- 2026-01-20
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05574959. Inclusion in this directory is not an endorsement.