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

Completed · Phase 4

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

In brief

Key facts

Study ID: NCT05626478
Run by: Nicole Fram M.D.
People needed: 50
Starts: 2023-06-01
Expected to finish: 2025-02-05
Last updated by the study team: 2026-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 eyes
Are willing and able to comply with clinic visits and study related procedures
Are willing and able to sign the informed consent form

You may not qualify if…

Under the age of 18 at the time of signing the Informed Consent Form
Pregnant or planning to become pregnant during the trial period
Have visual acuity potential of less than 20/30 as recorded by a Retinal Acuity Meter or Potential Acuity Meter glare testing
Have active infectious systemic disease
Have active infectious ocular or extraocular disease
Have punctal plug in the study eye
Have obstructed nasolacrimal duct in the study eye(s) (dacryocystitus)
Have known hypersensitivity to dexamethasone or are a known steroid responder
Have a history of ocular inflammation or macular edema
Has history of Laser Vision Correction (LASIK, PhotoRefractive Keratectomy) in the operated eye
Are currently being treated with immunomodulating agents in the study eye
Are currently being treated with immunosuppressants and/or oral steroids
Are 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 eye
Have a history of complete punctal occlusion in one or both punctum
Currently using topical ophthalmic steroid medications
Are unwilling or unable to comply with the study protocol
Are 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

Where it is running

Advanced Vision Care — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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