The PRIME Study: A Randomized, Controlled, Prospective Study

Recruiting now · Phase 4

Conditions studied: Patient Preference, Patient Outcomes, Post-Operative Inflammation, Grade of Post-Operative Cystoid Macular Edema, Rate of Post-Operative Cystoid Macular Edema

In brief

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.

Key facts

Study ID: NCT04549935
Run by: Vance Thompson Vision - MT
People needed: 20
Starts: 2020-09-14
Expected to finish: 2021-08-27
Last updated by the study team: 2020-09-16

Who can join

Age: 22 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify 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 may not qualify 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
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

Where it is running

Briana Parker — Bozeman, Montana, United States (enrolling)

Full record on ClinicalTrials.gov

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