Dextenza in the Post-op Management of Vitreoretinal Surgeries
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Cleveland Clinic
About this trial
This study will assess the control of inflammation at days 1, 7, 14, and 21 days following the vitreoretinal surgical procedure analyzing two randomized study arms: Intracanalicular dexamethasone insert group or topical steroid drop group.
Patients must be 18 years of age and older, of any race and either sex, requiring surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction.
Eligibility criteria
Qualifiers
Men and women >18 years old
Planning to undergo vitreoretinal surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction.
Disqualifiers
Patients undergoing combined cataract or glaucoma procedure, intraocular lens exchange, scleral buckle, and/or implant of a drug delivery system
History of complications, trauma, adverse events, disease in nasolacrimal region, including dacryocystitis, canaliculitis in either eye
Structural lid abnormalities such as ectropion or entropion in surgical eye
Ongoing use of systemic narcotic pain relievers
Trial design
Treatments tested in this trial
- Dexamethasone Ophthalmic Insert
- Prednisolone Acetate 1% Oph Susp
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
The Cleveland Clinic
Lead sponsor
Ocular Therapeutix, Inc.
Collaborator
Source ClinicalTrials.gov