Cataract Clinical Trial
Official title:
The Reggio Emilia Study on Bromfenac for Patients With PseudoEXfoliation Syndrome Undergoing Cataract Surgery: the REPEX Study
OBJECTIVE To evaluate the efficacy of bromfenac ophthalmic solution 0.09% for reducing
postoperative inflammation in eyes with pseudoexfoliation syndrome (PEX) undergoing cataract
surgery and receiving standard postoperative eye drops (dexamethasone 0.1% plus tobramycin
0.3% ophthalmic solution).
DESIGN Two arms, parallel group, randomized, single center, prospective, phase IV clinical
trial.
PARTICIPANTS Sixty-two subjects with PEX and cataract will be sequentially assigned,
according to a computer-generated randomization list (1:1), to bromfenac (n = 31) or not (n
= 31).
INTERVENTION Cataract surgery by means of phacoemulsification and implantation of
posterior-chamber intraocular lens will be performed by two experienced ophthalmic surgeons.
Standard Arm: only a standard antibiotic and steroid ophthalmic suspension will be given
starting the day after the surgery for two weeks, dosed QID for the first week and BID for
the second week (dexamethasone 0.1% and tobramycin 0.3% eye drops association).
Experimental Arm: eyes will receive bromfenac BID for two weeks starting the day after
surgery. Standard post-operative topical antibiotic and steroid will be also given
concurrently, dosed QID for the first week and BID for the second week (dexamethasone 0.1%
and tobramycin 0.3% eye drops association).
Measurements will be carried out at baseline and after one day, 3 days, 1 week and 4 weeks
from cataract extraction.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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