Dextenza in the Post-op Management of Vitreoretinal Surgeries

Launched by THE CLEVELAND CLINIC · Apr 29, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how well a medication called Dextenza can help control inflammation and pain after a specific eye surgery known as vitreoretinal surgery. The trial will compare two different ways of delivering treatment: a tiny insert placed in the eye that releases medication over time and traditional eye drops. Researchers will check how well each method works at various points after the surgery, specifically on days 1, 7, 14, and 21.

To participate, individuals must be at least 18 years old and planning to undergo vitreoretinal surgery for conditions like a macular hole or an epiretinal membrane. However, certain people are not eligible, such as those who have had specific eye complications or other surgeries recently. Participants can expect to receive either the medication insert or the eye drops, and they will be monitored to see how well their inflammation and pain are managed. This trial is currently actively recruiting participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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
• • Presence of any intraocular inflammation (cells and flare) in the study eye at screening/baseline
• • Pain score greater than "0" on the ocular pain assessment in the study eye at screening/baseline
• • Active or chronic or recurrent uncontrolled ocular or systemic inflammatory disease, including diabetes
• • Other ocular surgeries or procedures during the study period and/or 6 months prior
• • Intraoperative complications
• • Patients with history of glaucoma (defined as glaucoma requiring 2 or more drops, IOP at baseline greater than 25, or advanced optic nerve cupping). Patients with glaucoma or ocular hypertension controlled with a single drop can be enrolled.
• • Patients with a known hypersensitivity to NSAIDs or steroids or any component of the study medication.
• • Have used ocular, topical, or systemic NSAIDs within 7 days prior to procedure and during surgery.
• • Use of intracameral or subconjunctival NSAIDs or steroids intraoperatively.
• • Have used topical, ocular, inhaled or systemic steroids within 14 days prior to procedure
• • Are pregnant or nursing/lactating
• • Participation as a subject in any clinical study within the 30 days prior to randomization.
• • Surgeries using 20 gauge or 23 gauge instruments.