Investigate the intraocular pressure(pressure inside the eye) of patients who are treated with Lotemax after undergoing cataract surgery.
This is a single-center study to evaluate the clinical outcomes of Lotemax 0.5% for the treatment of Ocular inflammation associated with cataract surgery. Subjects will be screened from one to 21 days prior to initiation of dosing with the test article. Subjects who sign the informed consent document and meet all inclusion/exclusion criteria will be eligible to participate in this study. Subjects will instill one drop of Lotemax into the study (operative) eye QID for a maximum of 22 days. Dosing with test article will begin the day of surgery and for 21 days after surgery. Subjects will be seen for evaluation on Days 1, 7±1, and 21 ± 2 following surgery. Subjects will be seen for a follow-up visit on Day 42 ± 3 following surgery, about 21 days after their last dose of test article. In addition to the test article regimen, subjects will receive Vigamox TID 3 days prior to surgery. Patients will receive one drop of Timoptic XE 0.5%, Zymaxid on the day of surgery. Postoperatively, patients will receive Vigamox TID for ten days and Bromday QD for 3 weeks.
Study Type
OBSERVATIONAL
Enrollment
49
Lotemax to be used QID starting day of cataract surgery and 21 days after for total of 22 days.
Discover Vision Centers
Independence, Missouri, United States
Investigate Clinical Outcomes for Intraocular Pressure After Treatment With Lotemax (Loteprednol Ophthalmic Solution) 0.5% QID in Subjects Who Have Undergone Cataract Extraction With Posterior Chamber Intraocular Implantation.
Evaluate intraocular pressure change in mm Hg from baseline in the first 6 weeks following cataract surgery in individuals treated with Lotemax (loteprednol ophthalmic solution) 0.5% QID after cataract extraction with posterior chamber intraocular implantation.
Time frame: baseline to 6 weeks
ETDRS Letters Read Over Early Postoperative Period
Final visual acuity at pod 42 as measured by ETDRS letters read was compared with baseline was measured for this outcome measure.
Time frame: change in ETDRS letters read baseline to 6 weeks
Cell Scores in the Early Outcome Period as Measured at 6 Weeks Post Phacoemulsification
Cell scores at the final visit (pod 42) will be compared with baseline cells and will be measured using 1mmx1mm slit lamp beam. White cells present in the anterior chamber in a 1mm x 1mm slit lamp beam measured 3 times with the average number of cells being recorded. The grading scale was 0 (no cells/high power field), 1 (1-5 cells/high power field), 2 (6-15 cells/high power field), 3 (16-25 cells/high power field) and 4 (\>25 cells/high power field). Minimal values represent less inflammation or better inflammatory control and could represent a better outcome.
Time frame: baseline to 6 weeks
Flare Scores in Early Postoperative Period
Flare scores will be measured using a 1mmx1mm slit lamp beam. Flare was assessed by looking at a 1mmx1mm slit lamp beam into the anterior chamber. Three measurements were taken and the average flare score was reported. The final outcome measure was the final flare score at 42 days compared to baseline. The grading scale was 0-4 with 0 repesenting no flare, 1mild flare, 2 moderate flare, 3 moderate severe and 4 severe flare. Minmal values represent less inflammation and could represent better inflammatory control.
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Time frame: baseline to 6 weeks