DEXTENZA Compared to Topical Prednisolone in Patients Undergoing Bilateral LASIK Surgery
- Conditions
- Refractive Surgery
- Interventions
- Registration Number
- NCT04281862
- Lead Sponsor
- Vance Thompson Vision
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- 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
- Patients under the age of 18.
- 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.
- Patients with allergy or inability to receive topical antibiotic.
- Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) greater than 1,200 mg/day
- Patients with a corticosteroid implant (i.e. Ozurdex).
- Active or history of chronic or recurrent inflammatory eye disease in either eye
- Ocular pain in either eye
- Proliferative diabetic retinopathy in either eye
- Significant macular pathology detected on macular optical coherence tomography evaluation at the screening visit in either eye
- Laser or incisional ocular surgery during the study period and 6 months prior in either eye
- History of cauterization of the punctum
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group B Topical Prednisolone Topical Prednisolone Group A Dextenza 0.4Mg Ophthalmic Insert Dextenza
- Primary Outcome Measures
Name Time Method Patient Preference Through Month 1 (Day 28 +/- 3 days) As measured by COMTOL adapted survey.
Patient Comfort Through Month 1 (Day 28 +/- 3 days) As measured by SPEED Questionnaire.
- Secondary Outcome Measures
Name Time Method Ocular Surface Health Through Month 1 (Day 28 +/- 3 days) As measured by corneal staining.
Visual Outcomes Through Month 1 (Day 28 +/- 3 days) As measured by uncorrected Visual Acuity.
Ocular Pain Through Month 1 (Day 28 +/- 3 days) As measured by Ocular Pain Assessment.
Trial Locations
- Locations (1)
Vance Thompson Vision ND
🇺🇸W. Fargo, North Dakota, United States