Trials / Completed
CompletedNCT03708367
A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 117 (actual)
- Sponsor
- Johnson & Johnson Surgical Vision, Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
This is a post-market, prospective, randomized, multi-center, bilateral, open-label, cross-over, comparative clinical study. Study group will undergo preoperative LipiFlow treatment and Control group will not receive preoperative LipiFlow treatment. Three months postoperatively, both groups will be evaluated for clinical outcomes and the Control group will receive LipiFlow treatment as the cross-over group. The Control group will be evaluated at 4 months postoperative for clinical outcomes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LipiFlow Thermal Pulsation System | Treatment at preoperative visit for study group |
| DEVICE | LipiFlow Thermal Pulsation System | Treatment at 3 month visit as the cross-over group |
Timeline
- Start date
- 2018-10-16
- Primary completion
- 2020-01-13
- Completion
- 2020-01-13
- First posted
- 2018-10-17
- Last updated
- 2021-04-27
- Results posted
- 2021-04-27
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03708367. Inclusion in this directory is not an endorsement.