Bromfenac to Reduce Inflammation in Patients With Pseudoexfoliation Syndrome After Cataract Surgery
- Conditions
- Pseudoexfoliation SyndromeCataract
- Interventions
- Drug: Dexamethasone+Tobramycin eye drop
- Registration Number
- NCT02137161
- Lead Sponsor
- Arcispedale Santa Maria Nuova-IRCCS
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
- cataract
- pseudoexfoliation syndrome
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bromfenac Dexamethasone+Tobramycin eye drop Bromfenac eye drops (BID for two weeks starting the day after surgery) plus an antibiotic and steroid eye drop association (QID for the first week and BID for the second week) will be given concurrently to 31 patients. Bromfenac Bromfenac eye drop Bromfenac eye drops (BID for two weeks starting the day after surgery) plus an antibiotic and steroid eye drop association (QID for the first week and BID for the second week) will be given concurrently to 31 patients. Dexamethasone+Tobramycin eye drop Dexamethasone+Tobramycin eye drop An antibiotic and steroid eye drop association will be given starting the day after the surgery for two weeks, dosed QID for the first week and BID for the second week, to 31 patients.
- Primary Outcome Measures
Name Time Method Change from baseline in anterior chamber inflammation measured by Laser Flare Photometry (photon counts per millisecond) Baseline, Day 3 Reduction of 30% of anterior chamber inflammation evaluated by Laser Flare Photometry (LFP) in the bromfenac arm when compared to the non-bromfenac arm at postoperative day 3.
- Secondary Outcome Measures
Name Time Method Proportion of patients who had no ocular pain Baseline, Day 3 Proportion of patients with central macular thickness greater than 300 microns Baseline, Week 4 Macular thickness will be evaluated by Spectral Domain Optical Coherence Tomography (SD-OCT).
Proportion of subjects with best corrected visual acuity equal to 20/20 Baseline, Week 1
Trial Locations
- Locations (1)
Arcispedale Santa Maria Nuova IRCSS - Ophthalmology
🇮🇹Reggio Emilia, RE, Italy