CompletedPhase 4

Assessing Dextenza Insert After SMILE Procedure

United States20 participantsStarted 2020-06-18

Plain-language summary

This three-month prospective, open-label, single-center, randomized investigator initiated clinical study seeks to investigate the efficacy of DEXTENZA when placed in the lower canaliculus (study eye) compared to topical corticosteroids (control eye) following bilateral SMILE surgery. In addition, the study will evaluate physician assessment of ease of DEXTENZA insertion

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 years and older * Scheduled for bilateral SMILE surgery * Willing and able to comply with clinic visits and study related procedures * Willing and able to sign the informed consent form Exclusion Criteria: * Patients under the age of 18. * 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) * Patients being treated with immunosuppressants and/or oral steroids Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

What they're measuring

Mean Change in Pain

Timeframe: Change is being assessed at Baseline, Day 1, Day 7, Day 30 and Day 90

Trial details

NCT IDNCT04380857

SponsorWilliam Wiley, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06-21

Results submitted2023-06-09

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