Efficacy of Dextenza Insert in Upper vs Lower Punctum Following Cataract Surgery With PCIOL.

Completed · Phase 4

Conditions studied: Cataract

In brief

To assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.

Key facts

Study ID

NCT05372315

Run by

Iworks Laser and Vision Center

People needed

80

Starts

2022-06-15

Expected to finish

2022-10-31

Last updated by the study team

2023-08-23

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects will be eligible for study participation if they:
• Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes with or without iStent/Hydrus/Goniotomy.
• Are willing and able to comply with clinic visits and study related procedures.
• Are willing and able to sign the informed consent form.
• Not pregnant.

You may not qualify if…

• Subjects are not eligible for study participation if they:
• 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 use 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) or if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment.
• Have active infectious systemic disease.
• Have active infectious ocular or extraocular disease.
• Have unobstructed nasolacrimal duct in the study eye(s) (dacrocystitis).
• Have known hypersensitivity to dexamethasone or are a known steroid responder.
• Have a history of ocular inflammation or macular edema.
• Are currently being treated with immunomodulating agents in the study eye(s).
• Are currently being treated with immunosuppressants an/or oral steroids.
• Are Pregnant or breast-feeding or wish to become pregnant during the length of study participation.

Where it is running

• Iworks Laser & Vision Center — Dayton, Ohio, United States

Full record on ClinicalTrials.gov

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