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A Randomized, Controlled, Prospective Study of the Ocular Therapeutix Dextenza 0.4 mg Insert Compared to Topical Prednisolone for Post-Operative Inflammation in Patients Undergoing Bilateral Refractive Lens Exchange
Led by Vance Thompson Vision - MT · Updated on 2020-09-16
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the outcomes of patients undergoing bilateral refractive lens exchange (RLE) surgery by comparing two treatments for post-operative inflammation: a dexamethasone ophthalmic insert called Dextenza and a standard topical steroid drop, prednisolone acetate. The study focuses on patient preference between the insert and drops, as well as clinical outcomes including inflammation and the risk of cystoid macular edema after surgery. This is a randomized, controlled, prospective study designed to assess effectiveness and safety. In this study, one eye of each participant receives the Dextenza insert, which provides a sustained delivery of dexamethasone over 30 days with a single placement in the canaliculus. The other eye receives prednisolone acetate eye drops following a tapering schedule starting with four times daily for one week, then three times daily for one week, twice daily for one week, and once daily for a final week. All eyes also receive topical moxifloxacin four times daily for one week and topical Ilevro once daily for four weeks as part of standard post-operative care. Participants will have post-operative evaluations on Day 1, Day 7, and one month after surgery. Researchers will monitor patient preference, inflammation levels, pain scores, incidence and grade of corneal haze, anterior chamber cell count, and visual acuity measures during this period. The total participation time is approximately one month, during which safety and effectiveness outcomes related to the treatments will be collected and analyzed.
CONDITIONS
Brief Title
The PRIME Study: A Randomized, Controlled, Prospective Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients planning bilateral RLE surgery with best corrected visual acuity of 20/30 or better
- Willing and able to comply with clinic visits and study procedures
- Willing and able to sign the informed consent form
You will not qualify if you...
- Patients under 22 or over 75 years old
- Pregnant women or those who test positive for pregnancy
- Active infectious ocular or extraocular disease
- Current treatment with local or systemic immunosuppression including systemic corticosteroids
- Known hypersensitivity to dexamethasone
- Severe disease deemed unsafe for study participation by investigator
- History of ocular inflammation or macular edema
- Allergy or inability to receive intracameral antibiotic
- Use of systemic non-steroidal anti-inflammatory drugs (NSAIDs) over 1,200 mg/day
- Presence of corticosteroid implant (e.g., Ozurdex)
- Corneal pathology predisposing to unsatisfactory outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants undergo bilateral refractive lens exchange surgery. One eye receives a Dextenza insert delivering medication over 30 days, while the other eye receives topical prednisolone eye drops with a tapered dosing schedule over 4 weeks. All eyes also receive topical moxifloxacin and Ilevro as part of post-operative care.
Post-operative evaluations on Day 1, Day 7, and 1 Month
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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