Bromfenac to Reduce Inflammation in Patients With Pseudoexfoliation Syndrome After Cataract Surgery
This trial is active, not recruiting.
|Conditions||cataract, pseudoexfoliation syndrome|
|Treatments||dexamethasone+tobramycin eye drop, bromfenac eye drop|
|Sponsor||Arcispedale Santa Maria Nuova-IRCCS|
|Start date||November 2013|
|End date||November 2014|
|Trial size||62 participants|
|Trial identifier||NCT02137161, 2013-002066-39|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Change from baseline in anterior chamber inflammation measured by Laser Flare Photometry (photon counts per millisecond)
time frame: Baseline, Day 3
Proportion of patients with central macular thickness greater than 300 microns
time frame: Baseline, Week 4
Proportion of subjects with best corrected visual acuity equal to 20/20
time frame: Baseline, Week 1
Proportion of patients who had no ocular pain
time frame: Baseline, Day 3
Male or female participants at least 60 years old.
Inclusion Criteria: - cataract - pseudoexfoliation syndrome Exclusion Criteria: - history of ocular inflammation or trauma - previous intraocular surgery - corneal haze - retinal vascular disease - diabetic retinopathy - variation of the foveal profile at OCT (macular edema, epiretinal membrane) - moderate to severe age related macular degeneration
|Official title||The Reggio Emilia Study on Bromfenac for Patients With PseudoEXfoliation Syndrome Undergoing Cataract Surgery: the REPEX Study|
|Principal investigator||Marco Coassin, MD PhD|
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