Abstract
Purpose: :
The study was a prospective, multicenter comparative trial evaluating the effectiveness of Loteprednol 0.5% vs Prednisilone Acetate 1% for patients undergoing cataract surgery
Methods: :
The study was conducted as a prospective, masked evaluation of cataract surgery patients who received either Loteprednol 0.5% or brand-name Pred Forte (Prednisilone Acetate 1%). The patients were prescribed either loteprednol or prednisilone acetate, along with brand name bromfenac BID and besivance 0.6% BID starting 3 days before surgery. The topical steroid as well as topical NSAID was continued for 4 weeks postop. Besifloxacin was continued for 10 days postop. Outcome measures included change in CCT, UCVA in patients who ended up on target for distance (Spherical equivelant of -0.5 to +0.5, with 0.75 D of astigmatism or less, BSCVA, AC cell scores, IOP at 1 day, 1 week, and 1 month post-Op, as well as macular thickness as measured by high resolution OCT.
Results: :
31 subjects were enrolled in group A of the study and 34 were in enrolled in group B. 36% of the subjects in group A were male while 50% were male in Group B. Compared to preop, subjects in group A experienced an increase in CCT of 58, 15, and 4 microns at 1 day, 1 week and 1 month, respectively. Subjects in group B experienced an increase in CCT from pre-Op of 25, 16, and 5 microns at 1 day, 1 week and 1 month, respectively. 79% and 78.6% of subjects in group A and 90% and 94.4% of subjects in group B had a UCVA of 20/30 or better at 1 week and 1 month, respectively. 100% of patients in group A and 96.7% of patients in group B had a BSCVA of 20/30 or better at 1 week. At 1 month, 100% of patients in both groups had a BSCVA of 20/30 or better. Average AC cell scores at 1 week averaged 0.95 cells in group A and 0.82 cells in group B. Elevations in IOP (>21 mmHg) were noted in one patient only in group B at 1 month.
Conclusions: :
Subjects in groups A and B fared equally in regards to BSCVA of 20/30 or better at 1 week and 1 month post-Op. Patients in group B had a lower increase corneal thickness at 1 day, and achieved a higher percentage of eyes with an UCVA of 20/30 or better at 1 week and 1 month post-Op.
Clinical Trial: :
http://www.clinicaltrials.gov NCT01193504