UnknownPhase 4

A Study for Post op Inflammation After Cataract Surgery

United States40 participantsStarted 2023-01-30

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 procedures
✓. Are willing and able to sign the informed consent form
✓. Patients age 18yo+

Exclusion criteria

✕. Have active infectious systemic disease
✕. Have active infectious ocular or extraocular disease
✕. Have an obstructed nasolacrimal duct in the study eye(s) (dacryocystitis)
✕. 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 and/or oral steroids
✕. Are currently being treated with corticosteroid implant (i.e. Ozurdex)

What they're measuring

Absence of anterior chamber cells

Timeframe: at Day 14

Trial details

NCT IDNCT05665270

SponsorWyse Eyecare

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-31

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