Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2026-01-03 @ 11:04 PM
Study NCT ID:
NCT04380857
Status:
COMPLETED
Last Update Posted:
2023-10-06
First Post:
2020-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessing Dextenza Insert After SMILE Procedure
Sponsor:
William Wiley, MD
Organization:
Study Overview
Official Title:
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)
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: