NCT04371445 · The Cleveland Clinic
Dextenza in the Post-op Management of Vitreoretinal Surgeries
What this study is about
This study will assess the control of inflammation at days 1, 7, 14, and 21 days following the vitreoretinal surgical procedure analyzing two randomly assigned study treatment group$1: Intracanalicular dexamethasone insert group or topical steroid drop group.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Cleveland, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 10, 2026 · Source of record for eligibility and locations