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The PRIME Study: A Randomized, Controlled, Prospective Study

RecruitingPhase 4Ages 22 Years - 75 YearsAllVance Thompson Vision - MT
NCT04549935 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Dextenza
  • Topical Prednisolone
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Where

1 site
Briana Parker
Bozeman, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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