Refractive Surgery Clinical Trial
Official title:
DEXTENZA Compared to Topical Prednisolone in Patients Undergoing Bilateral LASIK
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.
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.
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