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New treatment option for Vitreoretinal Surgery
Official title Dextenza in the Post-op Management of Vitreoretinal Surgeries
ClinicalTrials.gov ID: NCT04371445
What this study is testing
What is Dexamethasone Ophthalmic Insert?
Dexamethasone Ophthalmic Insert is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for vitreoretinal surgery.
Also referred to as DEXTENZA®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.