The PRIME Study: A Randomized, Controlled, Prospective Study
Purpose
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
- Patient Preference
- Patient Outcomes
- Post-Operative Inflammation
- Grade of Post-Operative Cystoid Macular Edema
- Rate of Post-Operative Cystoid Macular Edema
Eligibility
- Eligible Ages
- Between 22 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion 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
Exclusion Criteria
- 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
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Group A Dextenza |
Drug: Dextenza 0.4mg Opthalmic Insert The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion, The attributes of the insert reduce risks for improper corticosteriod tapering and unwanted peaks and troughs in drug concentration. |
|
|
Active Comparator Group B Topical Prednisolone |
Drug: Topical Prednisolone Standard of care topical drop treatment |
|
Recruiting Locations
Bozeman, Montana 59718
More Details
- NCT ID
- NCT04549935
- Status
- Recruiting
- Sponsor
- Vance Thompson Vision - MT
Detailed Description
A Randomized, Controlled, Prospective Study design in which one eye (Group A) receives Dextenza and the second eye (Group B) receives prednisolone acetate 1% QID 1 week, TID 1 week, BID 1 week, and QD 1week, following bilateral RLE surgery. All eyes will receive topical moxifloxacin QID for one week and topical Ilevro QD for 4 weeks. Moxifloxacin and Ilevero are used in post-op regardless of the research. Post-operative evaluations to be performed on Day 1, Day 7, and 1 Month.