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The PRIME Study: A Randomized, Controlled, Prospective Study | Clinical Trials | Clareo Health

RECRUITINGPHASE4

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)

NCT04549935•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.

Detailed Description

A Randomized, Controlled, Prospective Study design in which one eye (Group A) receives Dextenza and the second eye (Group B) receives prednisolone acetate 1% QID 1 week, TID 1 week, BID 1 week, and QD 1week, following bilateral RLE surgery. All eyes will receive topical moxifloxacin QID for one week and topical Ilevro QD for 4 weeks. Moxifloxacin and Ilevero are used in post-op regardless of the research. Post-operative evaluations to be performed on Day 1, Day 7, and 1 Month.

Eligibility

Age

22 - 75 years

Sex

ALL

Healthy Volunteers

Yes

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).
+1 more criteria

Locations (1)

Briana Parker

Bozeman, Montana, United States

Key Dates

Start Date

September 14, 2020

Primary Completion Date

August 27, 2021

Completion Date

August 27, 2021

Last Updated

September 16, 2020

Enrollment

ESTIMATED participants

Conditions

Patient PreferencePatient OutcomesPost-Operative InflammationGrade of Post-Operative Cystoid Macular EdemaRate of Post-Operative Cystoid Macular Edema

Interventions

Dextenza

DRUG

Topical Prednisolone

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 16, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

The PRIME Study: A Randomized, Controlled, Prospective Study

Inclusion Criteria

Exclusion Criteria

TENS Unit for Analgesia During IUD Insertion

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