Dextenza in the Post-op Management of Vitreoretinal Surgeries

PHASE4RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

June 1, 2020

Primary Completion Date

December 1, 2025

Study Completion Date

December 1, 2025

Conditions
Vitreoretinal SurgeryOcular InflammationPost-operative PainPost-Operative Inflammation
Interventions
DRUG

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.

DRUG

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.

Trial Locations (1)

44195

RECRUITING

Cole Eye Institute, Cleveland Clinic, Cleveland

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Ocular Therapeutix, Inc.

INDUSTRY

lead

The Cleveland Clinic

OTHER