ESCRS - PREMED Study ;
ESCRS - PREMED Study ;

PREMED Study

European multicentre trial could transform understanding of CME after macular surgery

PREMED Study
Dermot McGrath
Dermot McGrath
Published: Sunday, October 6, 2013
A schematic view oif an IOL in the capsular bag with CME on OCT. © Rogier Trompert Medical Art, www.medical-art.nl A schematic view of an IOL in the capsular bag with CME on OCT. © Rogier Trompert Medical Art, www.medical-art.nl   After several years of rigorous preparation, the PREvention of Macular EDema after cataract surgery (PREMED) study has now enrolled its first patients. The ESCRS PREMED study is a European multicentre, randomised trial that could help to transform the current clinical management of cystoid macular edema (CME) after cataract surgery. Funded by a substantial grant from the ESCRS, the PREMED study is an initiative of the University Eye Clinic Maastricht, the Netherlands, under the supervision of Rudy Nuijts MD, PhD. “We are pleased that the first patients have now been recruited for this important trial which should prove of immense benefit to all ESCRS members and cataract surgeons,” said Dr Nuijts. “Thanks to the support of the ESCRS, we will hopefully be able to provide more definite evidence- based recommendations for clinical guidelines to prevent the occurrence of CME after cataract surgery in patients with and without diabetes mellitus. Lowering the number of drugs used during postoperative treatment after phacoemulsification may increase cost effectiveness and lower potential side effects,” he added. The PREMED study aims to enrol a total of 1,350 patients, 300 with diabetes mellitus and 1,050 without, who require cataract surgery in at least one eye. The inclusion period is scheduled to last for 18 months with 12 different centres in Europe and Russia taking part. The overall aim of the study is to answer some critical questions relating to the prevention of cystoid macular edema after cataract surgery, explained Laura Wielders MD, a researcher who is part of the PREMED study coordinating investigators group. “In the past few years, several new treatments have been tried to address the problem of CME after cataract surgery in diabetic and non-diabetic patients. However, no well-designed randomised controlled clinical trial has compared all the currently existing preventive strategies. This lack of well-designed trials and the large variety of treatments used in clinical practice was our major reason for starting the PREMED study,” she said. The study protocol has now been finalised, said Laura Wielders, with all patients undergoing phacoemulsification for cataract removal and placement of a posterior chamber intraocular lens. In the non-diabetic population, patients will receive either bromfenac 0.09 per cent eye drops twice daily starting two days before surgery and continuing two weeks postoperatively; dexamethasone disodium phosphate 0.1 per cent eye drops four times daily starting two days before surgery and continuing four times daily during the first postoperative week and one drop less per day every following week, or a combination of both drugs. These strategies will be compared for their efficacy in preventing central subfield mean macular thickening. Four Treatment Groups In the diabetic population, patients will be randomised into four treatment groups: (1) topical bromfenac 0.09 per cent and dexamethasone disodium phosphate 0.1 per cent; (2) topical bromfenac and dexamethasone and a subconjunctival injection of 40mg preservative-free triamcinolone acetonide (TA); (3) topical bromfenac and dexamethasone and an intravitreal injection of 1.25mg bevacizumab; (4) topical bromfenac and dexamethasone, a subconjunctival injection of 40mg preservative-free TA and an intravitreal injection of 1.25mg bevacizumab. The primary endpoint of the study is the change in central subfield mean macular thickness (CSMT) as compared to baseline at six weeks postoperatively. The secondary endpoint is the occurrence of clinically significant macular edema (CSME) within 12 weeks postoperatively. In case of CSME, treatment will be initiated and its effect will be part of the evaluation at 12 weeks. Medical data of all patients who develop CSME during the study will be checked at the end of the study and at least six months after surgery. At the end of the study, the hope is that clinicians will have a much clearer picture as to the optimum postoperative treatment regimen for cataract patients with and without diabetes mellitus. http://player.escrs.org/eurotimes-eye-contact/the-premed-study-rudy-nuijts
Tags: ESCRS
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