Marco Coassin1,2, Michele De Maria3,4, Valentina Mastrofilippo3, Luca Braglia5, Luca Cimino6, Antonio Sartori3, Luigi Fontana3. 1. Ophthalmology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy. m.coassin@unicampus.it. 2. Ophthalmology, University Campus Bio-Medico, Rome, Italy. m.coassin@unicampus.it. 3. Ophthalmology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy. 4. Clinical and Experimental Medicine PhD Program, University of Modena and Reggio Emilia, Modena, Italy. 5. Clinical Trials and Statistics Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy. 6. Ocular Immunology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.
Abstract
PURPOSE: To compare the efficacy of bromfenac 0.09% and dexamethasone 0.1% in the treatment of anterior chamber inflammation after uncomplicated cataract surgery. METHODS:Seventy-six patients with senile cataracts and no other ocular comorbidities who underwent uneventful phacoemulsification were randomized 1:1 to receive dexamethasone ophthalmic suspension 0.1% or bromfenac ophthalmic solution 0.09% for 2 weeks. All patients were examined on the day before surgery and postoperatively at day 1, 3, 7, 9, 11, 14 and 30. Laser flare photometry was used to quantify anterior chamber inflammation and optical coherence tomography to measure macular thickness. RESULTS: Bromfenac was as effective as dexamethasone in reducing inflammation in the anterior chamber of the eye. Laser flare increased the day after surgery and progressively decreased after starting the treatment with no statistically significant difference between dexamethasone and bromfenac at all time points. Visual acuity improved steadily after surgery in both groups. Mean macular thickness was similar in both the dexamethasone and bromfenac arms at 1 month. CONCLUSIONS: Short-term therapy with topical bromfenac alone is as effective as dexamethasone in low-risk cataract surgery patients. TRIAL REGISTRATION: ClinicalTrials.gov # NCT03317847; EudraCT # 2016-004358-14. FUNDING: Santa Maria Nuova Hospital IRCCS, Reggio Emilia, Italy.
RCT Entities:
PURPOSE: To compare the efficacy of bromfenac 0.09% and dexamethasone 0.1% in the treatment of anterior chamber inflammation after uncomplicated cataract surgery. METHODS: Seventy-six patients with senile cataracts and no other ocular comorbidities who underwent uneventful phacoemulsification were randomized 1:1 to receive dexamethasone ophthalmic suspension 0.1% or bromfenac ophthalmic solution 0.09% for 2 weeks. All patients were examined on the day before surgery and postoperatively at day 1, 3, 7, 9, 11, 14 and 30. Laser flare photometry was used to quantify anterior chamber inflammation and optical coherence tomography to measure macular thickness. RESULTS:Bromfenac was as effective as dexamethasone in reducing inflammation in the anterior chamber of the eye. Laser flare increased the day after surgery and progressively decreased after starting the treatment with no statistically significant difference between dexamethasone and bromfenac at all time points. Visual acuity improved steadily after surgery in both groups. Mean macular thickness was similar in both the dexamethasone and bromfenac arms at 1 month. CONCLUSIONS: Short-term therapy with topical bromfenac alone is as effective as dexamethasone in low-risk cataract surgery patients. TRIAL REGISTRATION: ClinicalTrials.gov # NCT03317847; EudraCT # 2016-004358-14. FUNDING: Santa Maria Nuova Hospital IRCCS, Reggio Emilia, Italy.