Assessing Dextenza Insert After SMILE Procedure

Completed · Phase 4

Conditions studied: Post Procedural Infection

In brief

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

Key facts

Study ID

NCT04380857

Run by

William Wiley, MD

People needed

20

Starts

2020-06-18

Expected to finish

2021-06-21

Last updated by the study team

2023-10-06

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cleveland Eye Clinic — Brecksville, Ohio, United States

Full record on ClinicalTrials.gov

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