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NCT03708367 · ClinicalTrials.gov registry record · NA
A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice
A NA study of Cataracts and Meibomian Gland Dysfunction (MGD), sponsored by Johnson & Johnson Surgical Vision.
- Completed
- Registry status
- NA
- Development phase
- 117
- Enrollment target
- 5
- Study locations
NCT03708367: Completed NA study of Cataracts and Meibomian Gland Dysfunction (MGD), sponsored by Johnson & Johnson Surgical Vision.
NCT03708367 is a NA study of Cataracts and Meibomian Gland Dysfunction (MGD) that has completed, run by Johnson & Johnson Surgical Vision. The registered enrollment target is 117 participants, above the 83-participant average among 8 other Cataracts trials with a reported enrollment target (41% higher). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03708367, a NA study of Cataracts and Meibomian Gland Dysfunction (MGD), has completed, sponsored by Johnson & Johnson Surgical Vision.
- COMPLETED
- Registry status
- NA
- Development phase
- 117 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
Uncorrected Distance Visual Acuity was measured for the Study and Control groups at the 3-month visit using the Clinical Trial Suite (M\&S Technologies) at 4.0 meters under photopic conditions (\~85 cd/m2).
Conditions Studied
Interventions
- DEVICE LipiFlow Thermal Pulsation System
Study Locations (5)
Texas
- JW Eye Associates, P.A. - Dallas
- Texas Eye & Laser Center, P.A. - Hurst
California
- Empire Eye & Laser Center, Inc. - Bakersfield
Maryland
- Eye Doctors of Washington - Chevy Chase
New Jersey
- Matossian Eye Associates - Pennington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2018-10-16 |
| Est. Completion | 2020-01-13 |
| Phase | NA |
What the finished NCT03708367 record still lists
NCT03708367 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, above the 83-participant average among 8 other Cataracts trials with a reported enrollment target (41% higher).
The record links to 2 conditions, with Cataracts appearing as the primary indexed condition, and to 1 intervention - of which LipiFlow Thermal Pulsation System is the first listed.
NCT03708367 lists 5 locations in 4 states (Texas, California, Maryland).
Frequently Asked Questions
What is clinical trial NCT03708367 about?
NCT03708367 is a clinical study titled "A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice". 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 ...
What is the current status of trial NCT03708367?
This trial is currently completed. It is a NA study. The enrollment target is 117 participants. The study started on 2018-10-16. Estimated completion is 2020-01-13.
What conditions does trial NCT03708367 study?
This clinical trial studies the following conditions: Cataracts, Meibomian Gland Dysfunction (MGD).
What interventions are being tested in trial NCT03708367?
The interventions under investigation include: LipiFlow Thermal Pulsation System (DEVICE).
Who is sponsoring clinical trial NCT03708367?
This trial is sponsored by Johnson & Johnson Surgical Vision, which has 22 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03708367 being conducted?
This trial has 5 study locations across California, Maryland, New Jersey, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03708367's enrollment target sits among peer trials
117 4th of 8 higher than 5 of 8 other Cataracts trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cataracts trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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