Assessing Dextenza Insert After SMILE Procedure

Phase 4

Completed

Interventions: Drug: Dexamethasone ophthalmic insert 0.4 mg
Drug: Topical Prednisolone Acetate Ophthalmic Drops

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

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Dexamethasone ophthalmic insert 0.4 mg	Dexamethasone ophthalmic insert 0.4 mg	Dexamethasone ophthalmic insert 0.4 mg
Topical prednisolone acetate ophthalmic drops	Topical Prednisolone Acetate Ophthalmic Drops	topical prednisolone acetate ophthalmic drops

Primary Outcome Measures

Name	Time	Method
Mean Change in Pain	Change is being assessed at Baseline, Day 1, Day 7, Day 30 and Day 90	post-op pain as measured as scores on an Ocular Pain Assessment Scale from 0-10 ("0" being no pain and "10" being the worst pain you could imagine)

Secondary Outcome Measures

Name	Time	Method
Post op Pain Management Per Eye	Day 0 to Day 90	Count of participants requiring pain management from Day 0 to Day 90.
Patient Preference Between Groups	Day 7, Day 30 and Day 90	As reported by patients choosing one of five options; Strongly preferred insert, preferred insert, no preference, preferred standard drop regimen, strongly preferred standard drop regimen.
Number of Lines Lost From Best Corrected Visual Acuity	Baseline through Day 90	After manifest refraction all units assessed for best corrected distance visual acuity using ETDRS. Number of lines seen was then converted to LogMar score (on a scale of -0.30 to 1.00 where smaller numbers indicate better vision and larger numbers indicate worse vision) to measure changes in Best Corrected Distance Visual Acuity between Baseline and Day 90
Loss of Lines in Uncorrected Visual Acuity	Baseline to Day 7, Day 30 and Day 90	All units assessed for uncorrected visual acuity using ETDRS. Number of lines seen was then converted to LogMar to measure changes in uncorrected visual acuity between Baseline and Day 90.