DEXTENZA Compared to Topical Prednisolone in Patients Undergoing Bilateral LASIK
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
- Last Updated
- 6 years ago
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 LASIK surgery.
Detailed Description
This prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to investigate the outcomes of patients undergoing bilateral LASIK surgery with the treatment of a dexamethasone intracanalicular insert compared to standard of care topical prednisolone. All eyes will receive treatment. Additionally, all eyes will receive topical moxifloxacin QID for 1 week. Twenty patient eyes undergoing bilateral LASIK surgery will be randomized to receive either Dextenza (Group A) OR standard of care prednisolone acetate 1% QID for 1 week, BID for 1 week (Group B). The contralateral eye will receive treatment with either DEXTENZA or topical prednisolone as a comparator based on randomization of first eye to Group A or Group B. Post-operative evaluations will be performed on Day 1, Day 7, and Month 1 following surgery.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Any adult patient who is planned to undergo bilateral LASIK surgery.
- •Refractive error between the 2 eyes of 2 Diopters or less
- •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 choose to have monovision after LASIK
- •Patients with corneal pathology that may interfere with LASIK outcomes
- •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.
Arms & Interventions
Group A
Dextenza
Intervention: Dextenza 0.4Mg Ophthalmic Insert
Group B
Topical Prednisolone
Intervention: Topical Prednisolone
Outcomes
Primary Outcomes
Patient Preference
Time Frame: Through Month 1 (Day 28 +/- 3 days)
As measured by COMTOL adapted survey.
Patient Comfort
Time Frame: Through Month 1 (Day 28 +/- 3 days)
As measured by SPEED Questionnaire.
Secondary Outcomes
- Ocular Surface Health(Through Month 1 (Day 28 +/- 3 days))
- Visual Outcomes(Through Month 1 (Day 28 +/- 3 days))
- Ocular Pain(Through Month 1 (Day 28 +/- 3 days))