Title
Assessing Dextenza Insert After SMILE Procedure
Assessing the Efficacy of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Lid Canaliculus in Comparison to Topical Prednisolone Acetate Following Bilateral Small Incision Lenticule Extraction (SMILE)
Phase
Phase 4Lead Sponsor
Cleveland Eye ClinicStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Post Procedural InfectionIntervention/Treatment
Dexamethasone ophthalmic insert 0.4 mg ...Study Participants
20This 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
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
intracanalicular dexamethasone insert
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
Dexamethasone ophthalmic insert 0.4 mg
topical prednisolone acetate ophthalmic drops
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
| Event Type | Organ System | Event Term | Dexamethasone Ophthalmic Insert 0.4 mg | Topical Prednisolone Acetate Ophthalmic Drops |
|---|
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)
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
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.
Count of participants requiring pain management from Day 0 to 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.
