A Randomized, Controlled, Masked (Reading Center) Prospective Study of the Effectiveness and Safety of the Ocular Therapeutix Dextenza 0.4 mg for the Treatment of Post-op. Inflammation and Pain in PRK
Overview
- Phase
- Phase 4
- Intervention
- Dextenza 0.4Mg Ophthalmic Insert
- Conditions
- Refractive Surgery
- Sponsor
- Vance Thompson Vision
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Patient Preference
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
To determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4mg) insert compared to standard steroid drop regimen in the contralateral eye following bilateral PRK surgery.
Detailed Description
Prospective Open-label Interventional Study Randomized, self-controlled design in which one eye (Group A) receives Dextenza and the second eye (Group B) receives prednisolone acetate 1% QID 1 week, BID 1 week following bilateral PRK surgery. All eyes will receive topical moxifloxacin QID for one week. Moxifloxacin in used post-op regardless of the research. Post-operative evaluations to be performed on Day 3 and Day 4, Month 1, and Month 3. Phone call survey to be performed on Week 2.
Investigators
Tiffany Facile
Principal Investigator
Vance Thompson Vision
Eligibility Criteria
Inclusion Criteria
- •Any adult patient who is planned to undergo bilateral PRK 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
- •Patients who are pregnant (must be ruled out in women of child-bearing age with pregnancy test).
- •Active infectious ocular or systemic disease.
- •Patients with active infectious ocular or extraocular disease.
- •Patients actively treated with local or systemic immunosuppression including systemic corticosteroids.
- •Patients with known hypersensitivity to Dexamethasone.
- •Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator.
- •Patients with a history of ocular inflammation or macular edema.
- •Patients with allergy or inability to receive intracameral antibiotic.
- •Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) greater than 1,200 mg/day
Arms & Interventions
Group A Dextenza
Will receive Dextenza post-operative
Intervention: Dextenza 0.4Mg Ophthalmic Insert
Group B Topical Prednisolone
Will receive standard of care prednisolone acetate 1% QID for 1 week, BID for 1 week
Intervention: Topical Prednisolone
Outcomes
Primary Outcomes
Patient Preference
Time Frame: Through Month 1 (Day 28 +/- 3 days)
Primary outcome of patient reference of dexamethasone insert versus topical steroid as measured by adapted Comparison of Ophthalmic Medications for Tolerability (COMToL) questionnaire.
Secondary Outcomes
- Mean Pain Score Per Eye (Group A: Dextenza vs. Group B: Topical Steroid)(Day 3)
- Percentage of Eyes Fully Epithelialized at Day 4 Postoperative(Postoperative Day 4)
- Percentage of Eyes Epithelialized at Day 3(Post-Operative Day 3)
- Uncorrected Distance Visual Acuity(Month 1 and Month 3.)
- Spectacle Corrected Distance Visual Acuity at Months 1 and 3 Post-operative(Month 1 and Month 3)
- SPEED Questionnaire Results at Baseline and Postoperative Day 28(Pre-op Visit and Month 1 (Day 28))