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The PRIME Study: A Randomized, Controlled, Prospective Study
NCT04549935 · View on ClinicalTrials.gov ↗
Study Summary
To investigate the outcomes of patients undergoing bilateral RLE surgery with treatment of dexamethasone intracanilicular insert compared to topical standard care steroid. Desiged to look at patient preference comparing the insert to drops and will also look at patient outcomes including inflammatin and risk of cystoid macular edema post-operatively.
Conditions Studied
Interventions
- DRUG Dextenza
- DRUG Topical Prednisolone
Study Locations (1)
Montana
- Briana Parker — Bozeman
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-09-14 |
| Est. Completion | 2021-08-27 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04549935
The ClinicalTrials.gov registry entry for NCT04549935 describes a study currently listed as recruiting. It is categorized as Phase 4, 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 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vance Thompson Vision - MT, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Patient Preference appearing as the primary indexed condition, and to 2 interventions — of which Dextenza 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: NCT04549935 reports 1 study location spanning 1 distinct geographic area — top geographies include Montana. 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 NCT04549935 about?
NCT04549935 is a clinical study titled "The PRIME Study: A Randomized, Controlled, Prospective Study". To investigate the outcomes of patients undergoing bilateral RLE surgery with treatment of dexamethasone intracanilicular insert compared to topical standard care steroid. Desiged to look at patient preference comparing the insert to drops and will also look at patient outcomes including inflammatin...
What is the current status of trial NCT04549935?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2020-09-14. Estimated completion is 2021-08-27.
What conditions does trial NCT04549935 study?
This clinical trial studies the following conditions: Patient Preference, Patient Outcomes, Post-Operative Inflammation, Grade of Post-Operative Cystoid Macular Edema, Rate of Post-Operative Cystoid Macular Edema. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04549935?
The interventions under investigation include: Dextenza (DRUG), Topical Prednisolone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04549935?
This trial is sponsored by Vance Thompson Vision - MT, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04549935 being conducted?
This trial has 1 study location across Montana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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