Patient Preference Clinical Trial
Official title:
A Prospective Trial Evaluating a Intracanalicular Insert Delivery System Compared to Traditional Topical Drops in Controlling Post-operative Pain and inFlammation in Subjects Undergoing Sequential Bilateral Cataract Surgery
To evaluate the safety and ocular efficacy of Dextenza in combination with an intracameral antibiotic and NSAID in controlling post-operative ocular pain and inflammation compared to standard of care topical therapy in patients undergoing bilateral cataract surgery.
This is a randomized, self-controlled prospective clinical study. On initial consultation
within one month of scheduled cataract surgery, each study subject will be randomized by a
random number generator to receive one of two treatment groups, either experimental or
control in the first eye. The second eye will undergo cataract surgery 2 weeks later and will
be treated with the other treatment group:
Experimental Group: A total of 50 study subjects (50 eyes) will receive Dextenza
dexamethasone intracanalicular insert placed in the lower punctum of their scheduled surgical
eye at the time of surgery and will receive intracameral ketorolac during the procedure and
50 micrograms of intracameral moxifloxacin at the conclusion of the procedure.
Control Group: A total of 50 study subjects (50 eyes) will receive topical moxifloxacin 0.5%
qid 1 day prior to surgery and for ten days postoperatively, ketorolac 0.5% qid 1 day prior
to surgery and for 1 month postoperatively, and prednisolone acetate 1.0% qid starting at the
conclusion of cataract surgery for 2 weeks and bid for 2 weeks in their scheduled surgical
eye.
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