Status:
COMPLETED
Assessing Dextenza Insert After SMILE Procedure
Lead Sponsor:
William Wiley, MD
Conditions:
Post Procedural Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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)...
Detailed Description
4.1 Study Population The study aims to enroll 20 patients undergoing bilateral SMILE. 4.1.1 Inclusion Criteria A patient's study eye must meet the following criteria to be eligible for inclusion in ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04380857
Start Date
June 18 2020
End Date
June 21 2021
Last Update
October 6 2023
Active Locations (1)
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1
Cleveland Eye Clinic
Brecksville, Ohio, United States, 44141