Actively Recruiting
The PRIME Study: A Randomized, Controlled, Prospective Study
Led by Vance Thompson Vision - MT · Updated on 2020-09-16
20
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The PRIME Study: A Randomized, Controlled, Prospective Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Patients under the age of 22 or above the age of 75
- Patients who are pregnant (must be ruled out in 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 corticosteroids
- Patients with known hypersensitivity to dexamethasone
- Patients with severe disease requiring critical attention, deemed unsafe by 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) greater than 1,200 mg/day
- Patients with a corticosteroid implant (e.g., Ozurdex)
- Patients with corneal pathology that predisposes them to unsatisfactory outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Briana Parker
Bozeman, Montana, United States, 59718
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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