Phase 4
Completed N=40
Assessing Dextenza Insert After SMILE Procedure
Post Procedural Infection
Source: ClinicalTrials.gov NCT04380857 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcomePrimary: Mean Change in Pain — 0.15; 0.20; 0.95; 0.90 Score on a scale from 0-10
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Pain |
0.15; 0.20; 0.95; 0.90; 0.47; 0.37 | — |
| SECONDARY Number of Lines Lost From Best Corrected Visual Acuity |
0; 0 | — |
| SECONDARY Loss of Lines in Uncorrected Visual Acuity |
-0.010; 0.013; -0.014; -0.026; -0.071; -0.068 | — |
| SECONDARY Post op Pain Management Per Eye |
0; 0 | — |
| SECONDARY Patient Preference Between Groups |
14; 2; 4; 11; 3; 3 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04380857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.