The PRIME Study: A Randomized, Controlled, Prospective Study

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age22-75
SponsorVance Thompson Vision - MT

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Dextenza
  • Topical Prednisolone

Treatment groups

20 Participants
are divided into 2 treatment groups

Sponsors and collaborators