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A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice
NCT03708367 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03708367
The ClinicalTrials.gov registry entry for NCT03708367 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 117 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johnson & Johnson Surgical Vision, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03708367 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Texas, California, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03708367?
The interventions under investigation include: LipiFlow Thermal Pulsation System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03708367?
This trial is sponsored by Johnson & Johnson Surgical Vision, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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