Using a dexamethasone insert to manage pain and inflammation after vitreoretinal surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a dexamethasone intracanalicular insert compared to traditional topical steroid drops in controlling inflammation and pain following vitreoretinal surgery. Patients aged 18 and older undergoing pars plana vitrectomy for conditions like macular hole or epiretinal membrane removal will be randomly assigned to receive either the insert or topical drops. The study will assess inflammation control at multiple time points post-surgery, providing insights into the reliability of continuous drug delivery versus patient adherence to topical treatments.

Why it matters

Who can join: the full rules

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 it's running

• Cole Eye Institute, Cleveland Clinic
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Katherine Talcott, M.D. — Cole Eye Institute, Cleveland Clinic
• Study coordinator: Katherine Talcott, M.D.
• Email: talcotk@ccf.org
• Phone: 440 988-4040

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.