The PRIME Study: A Randomized, Controlled, Prospective Study

Part of paid clinical trials in Bozeman, Montana.

Sponsor
Vance Thompson Vision - MT
Study ID
NCT04549935
Phase
PHASE4
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
22 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Dextenza — DRUG
    Dextenza 0.4mg
  • Topical Prednisolone — DRUG
    Standard of care topical drop treatment

Study Details

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.

Key Dates

Start date
Sep 14, 2020
Status verified
Aug 2020
Primary completion
Aug 27, 2021
Completion
Aug 27, 2021

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group A Dextenza
    Drug: Dextenza 0.4mg Opthalmic Insert The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion, The attributes of the insert reduce risks for improper corticosteriod tapering and unwanted peaks and troughs in drug concentration.
  • Active Comparator: Group B Topical Prednisolone
    Drug: Topical Prednisolone Standard of care topical drop treatment

Primary Outcome Measure

Patient Preference [ Time Frame: Through Month 1 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Briana ParkerBozemanMontana59718
Briana Parker
[email protected]
406-599-5961
Keeley Puls
[email protected]
605 371-7075
Russell Swan, MD (PRINCIPAL_INVESTIGATOR)
Travis Whitt, OD (SUB_INVESTIGATOR)
Seirra Steiner, OD (SUB_INVESTIGATOR)

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