Completed

NCT Number: NCT04380857

Assessing Dextenza Insert After SMILE Procedure

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

Completed

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Key information

Conditions

Post Procedural Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cleveland Eye Clinic

Brecksville, Ohio, 44141, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone ophthalmic insert 0.4 mg

Drug

intracanalicular dexamethasone insert

Other names: Dextenza

Topical Prednisolone Acetate Ophthalmic Drops

Drug

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

Other names: Prednisolone Acetate

Primary outcomes

Mean Change in Pain

Time frame: 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 outcomes

Number of Lines Lost From Best Corrected Visual Acuity

Time frame: 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

Time frame: 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.
Post op Pain Management Per Eye

Time frame: Day 0 to Day 90

Count of participants requiring pain management from Day 0 to Day 90.
Patient Preference Between Groups

Time frame: 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.

Sponsors and collaborators

Lead sponsor

William Wiley, MD

Other

Registry information

Official study 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)

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: May 8, 2020
Registry last updated: Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.