Dextenza Within Upper Lid Canaliculus Compared With Lower Lid Canaliculus Following Bilateral Cat… (NCT04592081) | Clinical Trial Compass
UnknownPhase 4
Dextenza Within Upper Lid Canaliculus Compared With Lower Lid Canaliculus Following Bilateral Cataract Extraction Surgery With PCIOL.
United States20 participantsStarted 2020-08-01
Plain-language summary
Assessing DEXTENZA efficacy when placed within the upper eyelid canaliculus as opposed to the lower eyelid canaliculus.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Been diagnosed with clinically significant cataract and CE/PCIOL has been planned
* Bilateral cataract surgery with IOL has been planned
* Willing and able to comply with clinic visits and study related procedures
* Willing and able to sign the informed consent form
Exclusion Criteria:
* Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
* Active infectious systemic disease
* Active infectious ocular or extraocular disease
* Obstructed nasolacrimal duct in the study eye(s)
* Hypersensitivity to dexamethasone
* Patients being treated with immunomodulating agents in the study eye(s)
* History of prior ocular surgery, excluding Lasik or PRK
* History of ocular inflammation or macular edema
* Use of any systemic NSAIDs greater than 375 mg per day
* Patients being treated with immunosuppressants and/or oral steroids
* Patients with a corticosteroid implant (i.e. Ozurdex)
* Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator