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The PRIME Study: A Randomized, Controlled, Prospective Study

NCT04549935 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-09-16

No results posted yet for this study

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.

Conditions

  • Patient Preference
  • Patient Outcomes
  • Post-Operative Inflammation
  • Grade of Post-Operative Cystoid Macular Edema
  • Rate of Post-Operative Cystoid Macular Edema

Interventions

DRUG

Dextenza

Dextenza 0.4mg

DRUG

Topical Prednisolone

Standard of care topical drop treatment

Sponsors & Collaborators

  • Vance Thompson Vision - MT

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-14
Primary Completion
2021-08-27
Completion
2021-08-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04549935 on ClinicalTrials.gov