Phase
Condition
Inflammation
Uveitis
Iritis
Treatment
Dexamethasone Ophthalmic Insert
Prednisolone Acetate 1% Oph Susp
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Study Description
Connect with a study center
Cole Eye Institute, Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
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