Clinical trial NCT02137161: Bromfenac to Reduce Inflammation in Patients With Pseudoexfoliation Syndrome After Cataract Surgery
Official title: The Reggio Emilia Study on Bromfenac for Patients With PseudoEXfoliation Syndrome Undergoing Cataract Surgery: the REPEX Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Pseudoexfoliation Syndrome
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2014-05-13
Enrollment: 62
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in anterior chamber inflammation measured by Laser Flare Photometry (photon counts per millisecond)
timeFrame: Baseline, Day 3
Secondary outcomes:
measure: Proportion of patients with central macular thickness greater than 300 microns
timeFrame: Baseline, Week 4
measure: Proportion of subjects with best corrected visual acuity equal to 20/20
timeFrame: Baseline, Week 1
measure: Proportion of patients who had no ocular pain
timeFrame: Baseline, Day 3
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova IRCSS - Ophthalmology
state: RE
Study officials:
affiliation: Arcispedale S. Maria Nuova IRCCS
name: Marco Coassin, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arcispedale S. Maria Nuova IRCCS
name: Luigi Fontana, MD PhD
role: STUDY_CHAIR
References: