Recruiting

Dexamethasone & Steroid DropsDextenza in the Post-op Management of Vitreoretinal Surgeries

Sponsor:

The Cleveland Clinic

Code:

NCT04371445

Conditions

Vitreoretinal Surgery

Ocular Inflammation

Post-operative Pain

Post-Operative Inflammation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dexamethasone Ophthalmic Insert

Prednisolone Acetate 1% Oph Susp

Study Details

Brief summary:

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.

Conditions

Vitreoretinal Surgery

Ocular Inflammation

Post-operative Pain

Post-Operative Inflammation

Study ID

NCT04371445

Start date

Jun 1, 2020

Status verified date

Jul, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intracanalicular dexamethasone insert group

This arm will receive the DEXTENZA® insert within minutes after the completion of the surgery.

active comparator: Topical steroid drop group

This arm will receive the prescription for daily prednisolone acetate 1% eye drops 4 times a day for the first week following the procedure, starting on the day of surgery.

Interventions

Dexamethasone Ophthalmic Insert

DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care including topical antibiotics.

Prednisolone Acetate 1% Oph Susp

Prednisolone acetate 1% eye drops are used 2-4 times daily for 30 days as the current standard of care for treating inflammation and eye pain after cataract surgery. Prednisolone, like dexamethasone, is a steroid. This arm will also receive the standard of care including topical antibiotics.

Primary outcome measure

To assess control of inflammation following the vitreoretinal surgical procedure. [ Time Frame: day 14 following surgery ]

Central Contacts and Locations

Central contacts

Katherine Talcott, M.D.

440 988-4040 talcotk@ccf.org

Angela Meador, MHA

216-445-7176 meadora@ccf.org

Locations

Cole Eye Institute, Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Rishi Singh, M.D

216-445-9497 singhr@ccf.org

More Information

Sponsor

The Cleveland Clinic

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

dexamethasone insert
Ocular Inflammation
Post-Operative Inflammation
Post-operative Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-07-29.