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New treatment option for Patient Preference
Official title The PRIME Study: A Randomized, Controlled, Prospective Study
ClinicalTrials.gov ID: NCT04549935
What this study is testing
What is Dextenza?
Dextenza is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for patient preference.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Any adult patient who is planned to undergo bilateral RLE surgery with BCVA 20/30 or better
- Willing and able to comply with clinic visits and study related procedures
- Willing and able to sign the informed consent form
You likely can't join if
- Patients under the age of 22 or above the age of 75
- Patients who are pregnant (must be ruled out in a women of child-bearing age with pregnancy test).
- Patients with active infectious ocular or extraocular disease.
- Patients actively treated with local or systemic immunosuppression including systemic corticosteriods
- Paitents with know hypersensitivity to Dexamethasone
- Patients with severe disease that warrants critical attentino, deemed unsafe for the study by the investigator
See the full eligibility criteria
- Any adult patient who is planned to undergo bilateral RLE surgery with BCVA 20/30 or better
- Willing and able to comply with clinic visits and study related procedures
- Willing and able to sign the informed consent form
- Patients under the age of 22 or above the age of 75
- Patients who are pregnant (must be ruled out in a women of child-bearing age with pregnancy test).
- Patients with active infectious ocular or extraocular disease.
- Patients actively treated with local or systemic immunosuppression including systemic corticosteriods
- Paitents with know hypersensitivity to Dexamethasone
- Patients with severe disease that warrants critical attentino, deemed unsafe for the study by the investigator
- Patients with a history of ocular inflammation or macular edema
- Patients with allergy or inability to receive intracameral antibiotic
- Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) grater than 1,200 mg/day
- Patient with a corticosteriod implant (i.e. Ozurdex).
- Patient with corneal pathology which pre-disposes them to unsatisfactory outcomes
The study team makes the final eligibility decision.
Where it's taking place
- Bozeman, Montana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bozeman, Montana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.