Conditions: Post Procedural Infection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 20
Healthy volunteers: no

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) compared to topical corticosteroids (control eye) following bilateral SMILE surgery. In addition, the study will evaluate physician assessment of ease of DEXTENZA insertion

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 the study:

* 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

4.1.2 Exclusion Criteria

A patient who meets any of the following criteria will be excluded from the study:

* 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

Arms:
arm 1: Dexamethasone ophthalmic insert 0.4 mg arm 2: topical prednisolone acetate ophthalmic drops

Interventions: intervention 1: Dexamethasone ophthalmic insert 0.4 mg intervention 2: Topical Prednisolone Acetate Ophthalmic Drops
Intervention descriptions: intervention 1: intracanalicular dexamethasone insert intervention 2: Topical Prednisolone acetate ophthalmic drops per standard of care:

Every two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue

Protocol document:
SAP_002.pdf: 



Prot_000.pdf: