Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt Treating Pain, and inflamMation Following Cataract Surgery Compared to Topical Prednisolone Acetate 1%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
DEXTENZA 0.4Mg Ophthalmic Insert is a corticosteroid (to decrease inflammation) intracanalicular insert placed in the punctum, a natural opening in the eye lid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives.
Prednisolone Acetate 1% is a corticosteroid (to decrease inflammation) and being used as a topical drop after cataract surgery per Standard Of Care.
Prolensa 0.07% is a NSAID (to decrease inflammation, swelling and pain) and is being used as a topical drop after cataract surgery per Standard Of Care.
Advanced Vision Care
Los Angeles, California, United States
Mean change in anterior chamber inflammation (Cell and Flare) scores
Measured by SUN (Standardization on Uveitis Nomenclature) grading scale: absence of cell to be defined as a grade of 0-0.5 and absence of flare to be defined as a grade of: 0-1. 0-4 score scale, higher scores mean a worse outcome. 0-1 Absent, 1-2 Mild, 2-3 Moderate, 4 Severe.
Time frame: Assessed on Days 1,7,30,90
Mean change in pain score
Measured with the visual analog scale (VAS); between 0 and 100; 0 meaning no pain and 100 meaning worst pain possible, higher scores mean a worse outcome. 0-10 Absent, 11-30 Mild, 31-70 Moderate, 71-100 Severe.
Time frame: Assessed on Day 1,7, 30 and 90
Visual outcome (Best Corrected Visual Acuity)
Measured by ETDRS (Early Treatment Diabetic Retinopathy Study) chart. 0-70 letter read score, higher scores mean a better outcome.
Time frame: Assessed on Day 1,7, 30 and 90
Absence of CME (Cystoid Macular Edema)
Macular thickness measured by OCT (Optical Coherence Tomography) and compared to the preop measurements, higher scores (\>over 50 microns) mean a worse outcome.
Time frame: Assessed on Day 90
Mean change in corneal staining
measured by the National Eye Institute 0-4 score scale, higher scores mean a worse outcome. 0-1 Mild, 2-3 Moderate, 4 Severe. Total score 0-5 Mild, 6-15 Moderate, 16-20 Severe.
Time frame: Assessed on Day 7, 30 and 90
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