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RecruitingAccepts healthy volunteersPhase 4

The PRIME Study: A Randomized, Controlled, Prospective Study

Vance Thompson Vision - MT · NCT04549935

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 22–75 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
20
US sites recruiting
1
Study start
September 14, 2020
Record last updated
September 16, 2020

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Dextenza; Topical Prednisolone

Conditions: Patient Preference; Patient Outcomes; Post-Operative Inflammation; Grade of Post-Operative Cystoid Macular Edema; Rate of Post-Operative Cystoid Macular Edema

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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).
  • Patient with corneal pathology which pre-disposes them to unsatisfactory outcomes

Recruiting US locations

  • Briana Parker

    Bozeman, MT 59718

    Site contact: Briana Parker · 406-599-5961 · briana.parker@vancethompsonvision.com

All healthy volunteers studies in Montana →
The PRIME Study: A Randomized, Controlled, Prospective Study (NCT04549935) | Bored Studies