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Not Yet Recruiting NCT05626478

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery

Conditions: Corneal Edema, Corneal Defect, Anterior Chamber Inflammation, Ocular Pain, Corneal Staining, Visual Outcome, CME - Cystoid Macular Edema

Sex: All
Ages: 18 Years – N/A
Phase: PHASE4
Enrollment: 100
Sponsor: Nicole Fram M.D.

Location: United States

Summary

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery

Eligibility Criteria

Inclusion Criteria:Diagnosed with clinically significant cataract and are planning to undergo non-complicated Clear Cornea Incision Cataract Extraction with Posterior Capsule IntraOcular Lens in one or both eyesAre willing and able to comply with clinic visits and study related proceduresAre willing and able to sign the informed consent formExclusion Criteria:Under the age of 18 at the time of signing the Informed Consent FormPregnant or planning to become pregnant during the trial periodHave visual acuity potential of less than 20/30 as recorded by a Retinal Acuity Meter or Potential Acuity Meter glare testingHave active infectious systemic diseaseHave active infectious ocular or extraocular diseaseHave punctal plug in the study eyeHave obstructed nasolacrimal duct in the study eye(s) (dacryocystitus)Have known hypersensitivity to dexamethasone or are a known steroid responderHave a history of ocular inflammation or macular edemaHas history of Laser Vision Correction (LASIK, PhotoRefractive Keratectomy) in the operated eyeAre currently being treated with immunomodulating agents in the study eyeAre currently being treated with immunosuppressants and/or oral steroidsAre currently being treated with corticosteroid implant (i.e Ozurdex)Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eyeHave a history of complete punctal occlusion in one or both punctumCurrently using topical ophthalmic steroid medicationsAre unwilling or unable to comply with the study protocolAre determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular disease/abnormality) if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05626478). StuddyBuddy aggregates publicly available trial information.