Dextenza in the Post-op Management of Vitreoretinal Surgeries

Last updated: September 4, 2024
Sponsor: The Cleveland Clinic
Overall Status: Active - Recruiting

Phase

4

Condition

Inflammation

Uveitis

Iritis

Treatment

Dexamethasone Ophthalmic Insert

Prednisolone Acetate 1% Oph Susp

Clinical Study ID

NCT04371445
4-29-2020
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men and women >18 years old

  • Planning to undergo vitreoretinal surgery with the procedure type of pars planavitrectomy for either the indication of macular hole, epiretinal membrane removal,or vitreomacular traction.

Exclusion

Exclusion Criteria:

  • Patients undergoing combined cataract or glaucoma procedure, intraocular lensexchange, 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 atscreening/baseline

  • Pain score greater than "0" on the ocular pain assessment in the study eye atscreening/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 withglaucoma or ocular hypertension controlled with a single drop can be enrolled.

  • Patients with a known hypersensitivity to NSAIDs or steroids or any component of thestudy medication.

  • Have used ocular, topical, or systemic NSAIDs within 7 days prior to procedure andduring surgery.

  • Use of intracameral or subconjunctival NSAIDs or steroids intraoperatively.

  • Have used topical, ocular, inhaled or systemic steroids within 14 days prior toprocedure

  • Are pregnant or nursing/lactating

  • Participation as a subject in any clinical study within the 30 days prior torandomization.

  • Surgeries using 20 gauge or 23 gauge instruments.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Dexamethasone Ophthalmic Insert
Phase: 4
Study Start date:
June 01, 2020
Estimated Completion Date:
December 01, 2025

Study Description

Topical steroids are the current standard of care for managing postoperative pain and inflammation following vitreoretinal surgery. However, topical treatments are limited by the potential for patient non-adherence and variation in drug concentrations due to the intermittent nature of application. A corticosteroid insert, placed following surgery, provides the advantages of reliable and continuous drug delivery without the need for patients to adhere to a treatment regimen. Recently, DEXTENZA®, a dexamethasone intracanalicular insert was FDA-approved for the treatment of inflammation and pain following ophthalmic surgery. DEXTENZA® is placed into the canaliculus via the lower punctum and is designed to release steroid medication for 30 days.

The data is limited regarding the safety and efficacy of DEXTENZA® for postoperative management of vitreoretinal surgery. Herein, the aim of this study is to assess the management of pain and inflammation following retinal surgery when using a dexamethasone implant compared with topical steroids.

Connect with a study center

  • Cole Eye Institute, Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

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