W. Fargo, North Dakota 58078

  • Refractive Surgery

Purpose:

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.


Study summary:

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.


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 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


NCT ID:

NCT04281862


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

W. Fargo, North Dakota 58078
United States

Sarah Thiede
Phone: 701-566-5390
Email: sarah.thiede@vancethompsonvision.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 02, 2021

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