Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT04371445

Dextenza in the Post-op Management of Vitreoretinal Surgeries

Led by The Cleveland Clinic · Updated on 2026-02-10

30

Participants Needed

1

Research Sites

308 weeks

Total Duration

On this page

Sponsors

T

The Cleveland Clinic

Lead Sponsor

O

Ocular Therapeutix, Inc.

Collaborating Sponsor

AI-Summary

What this Trial 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 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

Official Title

Dextenza in the Post-op Management of Vitreoretinal Surgeries

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women over 18 years old
  • Planning to undergo vitreoretinal surgery with pars plana vitrectomy for macular hole, epiretinal membrane removal, or vitreomacular traction
Not Eligible

You will not qualify if you...

  • Undergoing combined cataract or glaucoma procedures, intraocular lens exchange, scleral buckle, or implant of a drug delivery system
  • History of complications or diseases in the tear drainage area, including dacryocystitis or canaliculitis
  • Structural eyelid abnormalities such as ectropion or entropion in the surgical eye
  • Ongoing use of systemic narcotic pain relievers
  • Presence of any intraocular inflammation at screening or baseline
  • Pain score greater than zero in the study eye at screening or baseline
  • Active, chronic, or uncontrolled ocular or systemic inflammatory disease, including diabetes
  • Other eye surgeries or procedures during the study or within 6 months prior
  • Intraoperative complications
  • History of glaucoma requiring two or more eye drops, baseline intraocular pressure over 25, or advanced optic nerve damage
  • Known hypersensitivity to NSAIDs, steroids, or any study medication components
  • Use of ocular or systemic NSAIDs within 7 days before surgery
  • Use of intracameral or subconjunctival NSAIDs or steroids during surgery
  • Use of topical, ocular, inhaled, or systemic steroids within 14 days before surgery
  • Pregnant or nursing/lactating women
  • Participation in any clinical study within 30 days prior to randomization
  • Surgeries using 20 gauge or 23 gauge instruments

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Cole Eye Institute, Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

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Research Team

K

Katherine Talcott, M.D.

CONTACT

A

Angela Meador, MHA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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