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RECRUITING
NCT04549935
PHASE4

The PRIME Study: A Randomized, Controlled, Prospective Study

Sponsor: Vance Thompson Vision - MT

View on ClinicalTrials.gov

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

Interventions

DRUG

Dextenza

Dextenza 0.4mg

DRUG

Topical Prednisolone

Standard of care topical drop treatment

Locations (1)

Briana Parker

Bozeman, Montana, United States