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The PRIME Study: A Randomized, Controlled, Prospective Study
Sponsor: Vance Thompson Vision - MT
Summary
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.
Official title: A Randomized, Controlled, PRospective Study of the Effectiveness and Safety of the Ocular Therapeutix Dextenza (Dexamethasone Ophthalmic Insert) 0.4 mg for the treatMEnt of Post-operative Inflammation in Patients Who Plan to Undergo Refractive Lens Exchange (RLE)
Key Details
Gender
All
Age Range
22 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2020-09-14
Completion Date
2021-08-27
Last Updated
2020-09-16
Healthy Volunteers
Yes
Conditions
Interventions
Dextenza
Dextenza 0.4mg
Topical Prednisolone
Standard of care topical drop treatment
Locations (1)
Briana Parker
Bozeman, Montana, United States