Laura H P Wielders1, Jan S A G Schouten2, Bjorn Winkens2, Frank J H M van den Biggelaar2, Claudette A Veldhuizen2, Joaquim C N Murta2, Willem R O Goslings2, Thomas Kohnen2, Marie-José Tassignon2, Maurits V Joosse2, Ype P Henry2, Zoltán Z Nagy2, Alexander H F Rulo2, Oliver Findl2, Michael Amon2, Rudy M M A Nuijts2. 1. From University Eye Clinic Maastricht UMC+, Maastricht University Medical Center+ (Wielders, Schouten, van den Biggelaar, Veldhuizen, Nuijts), Maastricht, Maastricht University, Care and Public Health Research Institute, Department of Methodology and Statistics (Winkens), Maastricht, Zuyderland Medical Center, Department of Ophthalmology (Wielders, Schouten, Nuijts), Heerlen; Elisabeth-TweeSteden Hospital, Department of Ophthalmology (Goslings), Tilburg, Haaglanden Medical Center, Department of Ophthalmology (Joosse), The Hague, VU University Medical Center, Department of Ophthalmology (Henry), Amsterdam, and Eye Hospital Zonnestraal (Rulo), Hilversum, the Netherlands; Centro Hospitalar Universitário Coimbra and Association for Innovation and Biomedical Research on Light (Murta), Coimbra, Portugal; Goethe University, Department of Ophthalmology (Kohnen); Frankfurt am Main, Germany Antwerp University Hospital and University of Antwerp, Department of Ophthalmology (Tassignon), Antwerp, Belgium Semmelweis University, Department of Ophthalmology (Nagy), Budapest, Hungary Vienna Institute for Research in Ocular Surgery, Hanusch Hospital (Findl), and Hospital of the Brothers of St. John of God, Department of Ophthalmology (Amon), Vienna, Austria. Electronic address: laura.wielders@mumc.nl. 2. From University Eye Clinic Maastricht UMC+, Maastricht University Medical Center+ (Wielders, Schouten, van den Biggelaar, Veldhuizen, Nuijts), Maastricht, Maastricht University, Care and Public Health Research Institute, Department of Methodology and Statistics (Winkens), Maastricht, Zuyderland Medical Center, Department of Ophthalmology (Wielders, Schouten, Nuijts), Heerlen; Elisabeth-TweeSteden Hospital, Department of Ophthalmology (Goslings), Tilburg, Haaglanden Medical Center, Department of Ophthalmology (Joosse), The Hague, VU University Medical Center, Department of Ophthalmology (Henry), Amsterdam, and Eye Hospital Zonnestraal (Rulo), Hilversum, the Netherlands; Centro Hospitalar Universitário Coimbra and Association for Innovation and Biomedical Research on Light (Murta), Coimbra, Portugal; Goethe University, Department of Ophthalmology (Kohnen); Frankfurt am Main, Germany Antwerp University Hospital and University of Antwerp, Department of Ophthalmology (Tassignon), Antwerp, Belgium Semmelweis University, Department of Ophthalmology (Nagy), Budapest, Hungary Vienna Institute for Research in Ocular Surgery, Hanusch Hospital (Findl), and Hospital of the Brothers of St. John of God, Department of Ophthalmology (Amon), Vienna, Austria.
Abstract
PURPOSE: To compare the efficacy of perioperative treatment strategies, in addition to topical bromfenac 0.09% and dexamethasone 0.1%, to reduce the risk for developing cystoid macular edema (CME) after uneventful cataract surgery in diabetic patients. SETTING: Twelve European study centers. DESIGN: Randomized clinical trial. METHODS:Diabetic patients having phacoemulsification cataract surgery were randomly allocated to receive no additional treatment, a subconjunctival injection with 40 mg triamcinolone acetonide, an intravitreal injection with 1.25 mg bevacizumab, or a combination of both. The main outcomes were the difference in central subfieldmean macular thickness, corrected distance visual acuity, and the incidence of CME and clinically significant macular edema within 6 and 12 weeks postoperatively. RESULTS: The study comprised 213 patients. At 6 and 12 weeks postoperatively, the central subfield mean macular thickness was 12.3 μm and 9.7 μm lower, respectively, in patients who received subconjunctival triamcinolone acetonide than patients who did not (P = .007 and P = .014, respectively). No patient who received subconjunctival triamcinolone acetonide developed CME. Intravitreal bevacizumab had no significant effect on macular thickness. CONCLUSIONS:Diabetic patients who received a subconjunctival injection with triamcinolone acetonide at the end of cataract surgery had a lower macular thickness and macular volume at 6 and 12 weeks postoperatively than patients who did not. Intravitreal bevacizumab had no significant effect.
RCT Entities:
PURPOSE: To compare the efficacy of perioperative treatment strategies, in addition to topical bromfenac 0.09% and dexamethasone 0.1%, to reduce the risk for developing cystoid macular edema (CME) after uneventful cataract surgery in diabeticpatients. SETTING: Twelve European study centers. DESIGN: Randomized clinical trial. METHODS:Diabeticpatients having phacoemulsification cataract surgery were randomly allocated to receive no additional treatment, a subconjunctival injection with 40 mg triamcinolone acetonide, an intravitreal injection with 1.25 mg bevacizumab, or a combination of both. The main outcomes were the difference in central subfield mean macular thickness, corrected distance visual acuity, and the incidence of CME and clinically significant macular edema within 6 and 12 weeks postoperatively. RESULTS: The study comprised 213 patients. At 6 and 12 weeks postoperatively, the central subfield mean macular thickness was 12.3 μm and 9.7 μm lower, respectively, in patients who received subconjunctival triamcinolone acetonide than patients who did not (P = .007 and P = .014, respectively). No patient who received subconjunctival triamcinolone acetonide developed CME. Intravitreal bevacizumab had no significant effect on macular thickness. CONCLUSIONS:Diabeticpatients who received a subconjunctival injection with triamcinolone acetonide at the end of cataract surgery had a lower macular thickness and macular volume at 6 and 12 weeks postoperatively than patients who did not. Intravitreal bevacizumab had no significant effect.
Authors: Lorenzo Iuliano; Gloria Cisa di Gresy; Giovanni Fogliato; Eleonora Corbelli; Francesco Bandello; Marco Codenotti Journal: Eye Vis (Lond) Date: 2021-08-04
Authors: Aldo Caporossi; Giovanni Alessio; Francesco Fasce; Giorgio Marchini; Antonio Rapisarda; Vincenzo Papa Journal: Clin Ophthalmol Date: 2021-06-30