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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
50
Drugs to be administer during cataract surgery to experimental group
Standard method used for surgery and the use of post operative drops
Ophthalmic Consultants of Long Island
Garden City, New York, United States
RECRUITINGPatient Preference
Patient preference for medication protocol between the two eyes as assessed by using a standard set of questions
Time frame: Day 28 of second eye surgery
Summed Ocular Inflamation Score
Sum of the mean anterior chamber cells and anterior flare score as measured by Slit Lamp Biomicroscopy
Time frame: Day 14 each eye
Surgical care
Patient assessment of surgical care quality as measured by the CAHPS survey
Time frame: Day 28 of second eye surgery
Post-operative pain
Absence of post-operative ocular pain as measured by ocular pain assessment numerical grading scale 0-10
Time frame: Day 7 each eye
Best Corrected Visual Acuity (BCVA)
Mean change in BCVA from baseline
Time frame: 2 month / 60 days Visit for second eye
Distance Visual Acuity (VA)
Mean change in Distance VA
Time frame: 2 month / 60 days Visit for second eye
Physician evaluation of insertion
Physician ease of intracanalicular insertion evaluation as measured by physician questionnaire
Time frame: Post-op Day 1 for experimental group
Adverse Events
Incidence and severity of ocular and systemic Adverse Events
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Time frame: 2 month / 60 days Visit for second eye