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Dextenza for Post-Vitreoretinal Surgery Inflammation and Pain

This study is looking at how well DEXTENZA® (a small insert that releases medicine) works to control inflammation and pain after vitreoretinal surgery (eye surgery for conditions like macular hole). Currently, eye drops like Prednisolone Acetate 1% are used. DEXTENZA® is placed in your lower eyelid and slowly releases a steroid called dexamethasone for up to 30 days, so you don't need to use daily eye drops. This study will compare DEXTENZA® to the standard eye drops. You might be able to join if you are an adult (18 or older) planning to have vitreoretinal surgery for macular hole, epiretinal membrane removal, or vitreomacular traction. The study aims to see how well inflammation is controlled 14 days after surgery. The study status is unclear, and it plans to enroll 30 participants.

Study design
This is an interventional study comparing two groups: one receiving the Dexamethasone Ophthalmic Insert and the other receiving Prednisolone Acetate 1% eye drops. It plans to enroll 30 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Inflammation will be assessed at days 1, 7, 14, and 21 following surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04371445

Dextenza in the Post-op Management of Vitreoretinal Surgeries

Recruiting
PHASE4Ages 18+InterventionalPrevention
The Cleveland Clinic
~30 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:Dexamethasone Ophthalmic InsertPrednisolone Acetate 1% Oph Susp

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess control of inflammation following the vitreoretinal surgical procedure.
Measured over day 14 following surgery

Conditions

Vitreoretinal Surgery
Ocular Inflammation
Post-operative Pain
Post-Operative Inflammation

Explore related trials

Epiretinal MembraneMacular HoleVitreomacular traction

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Katherine Talcott, M.D. · PRINCIPAL_INVESTIGATOR · Cole Eye Institute, Cleveland Clinic

Who to contact

Katherine Talcott, M.D.
[email protected]
440 988-4040
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • To assess control of inflammation following the vitreoretinal surgical procedure.day 14 following surgery

    Percentage of patients with Inflammation following surgery as assessed from 0-4+ cell and flare based on the Standardization of Uveitis Nomenclature \[SUN\] Working Group grading scheme at day 14