Dextenza Within Upper Lid Canaliculus Compared With Lower Lid Canaliculus Following Bilateral Cataract Extraction Surgery With PCIOL.
Status unconfirmed · Phase 4
Conditions studied: Post-Surgical Ocular Pain, Post-Surgical Ocular Inflammation
In brief
Assessing DEXTENZA efficacy when placed within the upper eyelid canaliculus as opposed to the lower eyelid canaliculus.
Key facts
- Study ID
- NCT04592081
- Run by
- Kerry Assil, MD
- People needed
- 20
- Starts
- 2020-08-01
- Expected to finish
- 2021-03-11
- Last updated by the study team
- 2020-10-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Assil Eye Institute — Beverly Hills, California, United States (enrolling)
Full record on ClinicalTrials.gov
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