Format

Send to

Choose Destination
J Cataract Refract Surg. 2018 Apr;44(4):429-439. doi: 10.1016/j.jcrs.2018.01.029.

European multicenter trial of the prevention of cystoid macular edema after cataract surgery in nondiabetics: ESCRS PREMED study report 1.

Author information

1
From University Eye Clinic Maastricht UMC+ (Wielders, Schouten, van den Biggelaar, Veldhuizen, Nuijts), Maastricht University Medical Center+, and Maastricht University (Winkens), Care and Public Health Research Institute (CAPHRI), Department of Methodology & Statistics, Maastricht, Zuyderland Medical Center (Wielders, Schouten, Nuijts), Department of Ophthalmology, Heerlen, Elisabeth-TweeSteden Hospital (Goslings), Department of Ophthalmology, Tilburg, Haaglanden Medical Center (Joosse); Department of Ophthalmology, The Hague, VU University Medical Center (Henry), Department of Ophthalmology, Amsterdam, and Eye Hospital Zonnestraal (Rulo), Hilversum, the Netherlands; Vienna Institute for Research in Ocular Surgery (Findl), Hanusch Hospital, Vienna, Austria; Centro Hospitalar Universitário Coimbra (Murta), Department of Ophthalmology, and Association for Innovation and Biomedical Research on Light (AIBILI), Coimbra, Portugal; Antwerp University Hospital and University of Antwerp (Tassignon), Department of Ophthalmology, Antwerp, Belgium; Instituto Microcirugia Ocular (Güell), Barcelona, Spain; Hospital of the Brothers of St. John of God (Amon), Department of Ophthalmology, Vienna, Austria; Goethe University (Kohnen), Department of Ophthalmology, Frankfurt am Main, Germany. Electronic address: laura.wielders@mumc.nl.
2
From University Eye Clinic Maastricht UMC+ (Wielders, Schouten, van den Biggelaar, Veldhuizen, Nuijts), Maastricht University Medical Center+, and Maastricht University (Winkens), Care and Public Health Research Institute (CAPHRI), Department of Methodology & Statistics, Maastricht, Zuyderland Medical Center (Wielders, Schouten, Nuijts), Department of Ophthalmology, Heerlen, Elisabeth-TweeSteden Hospital (Goslings), Department of Ophthalmology, Tilburg, Haaglanden Medical Center (Joosse); Department of Ophthalmology, The Hague, VU University Medical Center (Henry), Department of Ophthalmology, Amsterdam, and Eye Hospital Zonnestraal (Rulo), Hilversum, the Netherlands; Vienna Institute for Research in Ocular Surgery (Findl), Hanusch Hospital, Vienna, Austria; Centro Hospitalar Universitário Coimbra (Murta), Department of Ophthalmology, and Association for Innovation and Biomedical Research on Light (AIBILI), Coimbra, Portugal; Antwerp University Hospital and University of Antwerp (Tassignon), Department of Ophthalmology, Antwerp, Belgium; Instituto Microcirugia Ocular (Güell), Barcelona, Spain; Hospital of the Brothers of St. John of God (Amon), Department of Ophthalmology, Vienna, Austria; Goethe University (Kohnen), Department of Ophthalmology, Frankfurt am Main, Germany.

Erratum in

  • Erratum. [J Cataract Refract Surg. 2018]

Abstract

PURPOSE:

To compare the efficacy of a topical nonsteroidal antiinflammatory drug, topical corticosteroid, and a combination of both drugs to prevent the occurrence of cystoid macular edema (CME) after cataract surgery in nondiabetic patients.

SETTING:

Twelve European study centers.

DESIGN:

Randomized clinical trial.

METHODS:

Nondiabetic patients having uneventful cataract surgery were included in this study. Patients were randomized to receive topical bromfenac 0.09% twice daily for 2 weeks or dexamethasone 0.1% 4 times daily with 1 drop less per day every following week, or a combination of both. The primary outcome was the difference in central subfield mean macular thickness 6 weeks postoperatively. Secondary outcome measures included corrected distance visual acuity as well as the incidence of CME and clinically significant macular edema (CSME) within 6 weeks and 12 weeks postoperatively.

RESULTS:

This study comprised 914 patients. Six weeks postoperatively, the central subfield mean macular thickness was 288.3 μm, 296.0 μm, and 284.5 μm in the bromfenac group, dexamethasone group, and combination treatment group, respectively (overall P = .006). The incidence of clinically significant macular edema within 12 weeks postoperatively was 3.6%, 5.1%, and 1.5%, respectively (overall P = .043).

CONCLUSION:

Patients treated with a combination of topical bromfenac 0.09% and dexamethasone 0.1% had a lower risk for developing CSME after cataract surgery than patients treated with a single drug.

PMID:
29778106
DOI:
10.1016/j.jcrs.2018.01.029

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center