The PRIME Study: A Randomized, Controlled, Prospective Study

Launched by VANCE THOMPSON VISION - MT · Sep 14, 2020

Keywords

ClinConnect Summary

The PRIME Study is a clinical trial designed to compare two ways of treating inflammation after bilateral refractive lens exchange (RLE) surgery, which is a procedure to improve vision. The study will look at how well a special device that delivers medication (called a dexamethasone intracanilicular insert) works compared to traditional eye drops. Researchers want to understand not only which method helps reduce inflammation better but also how patients feel about each treatment option.

To be eligible for the trial, you need to be an adult between 22 and 75 years old, planning to have RLE surgery, and have good vision (20/30 or better). Participants will need to visit the clinic for follow-up appointments and will be asked to sign a consent form to join the study. If you join, you can expect regular check-ups to monitor your recovery, and you'll help researchers learn more about the best ways to manage post-operative care. This study is currently recruiting participants, and it's a great opportunity to contribute to advancing eye care for others in the future!

Gender

ALL

Eligibility criteria

• 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