RecruitingPhase 4NCT04549935

The PRIME Study: A Randomized, Controlled, Prospective Study

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)


Sponsor

Vance Thompson Vision - MT

Enrollment

20 participants

Start Date

Sep 14, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 22 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Dextenza and a drug called Topical Prednisolone for people with grade of post-operative cystoid macular edema, patient outcomes, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 22 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDextenza

Dextenza 0.4mg

DRUGTopical Prednisolone

Standard of care topical drop treatment


Locations(1)

Briana Parker

Bozeman, Montana, United States

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NCT04549935


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