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Enrolling By Invitation
NCT05665270
A Study for Post op Inflammation After Cataract Surgery
Conditions: Cataract
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: PHASE4
Enrollment: 40
Sponsor: Wyse Eyecare
Location: United States
Summary
This is a randomized, controlled study to assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert when utilized in conjunction with topical steroids as part of an extended taper steroid regimen following cataract surgery in patients with a history of epiretinal membrane, diabetic retinopathy, or non-exudative macular degeneration.
Eligibility Criteria
Inclusion Criteria:Subjects will be eligible for study participation if they:Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes and have a history of epiretinal membrane, diabetic retinopathy, or non-exudative macular degeneration.Are willing and able to comply with clinic visits and study related proceduresAre willing and able to sign the informed consent formPatients age 18yo+Exclusion Criteria:Subjects are not eligible for study participation if they:Have active infectious systemic diseaseHave active infectious ocular or extraocular diseaseHave an obstructed nasolacrimal duct in the study eye(s) (dacryocystitis)Have known hypersensitivity to dexamethasone or are a known steroid responderHave a history of ocular inflammation or macular edemaAre currently being treated with immunomodulating agents in the study eye(s)Are 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 use topical ophthalmic steroid medicationsAre currently pregnant or nursing.Are 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) or if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment
Source: ClinicalTrials.gov (NCT05665270). StuddyBuddy aggregates publicly available trial information.