Large European Study Highlights Benefit of Combination Treatment to Prevent Cystoid Macular Edema

Source: ESCRS

A combination of a topical corticosteroid and a nonsteroidal anti-inflammatory drug (NSAID) is more effective than either agent alone in reducing the risk of developing cystoid macular edema (CME) after cataract surgery in non-diabetic patients, according to the results of a major European study presented at the 35th Congress of the ESCRS in Lisbon, Portugal.

The ESCRS Prevention of Macular Edema after cataract surgery (PREMED) study is the first international multicenter randomised controlled clinical trial specifically designed to answer questions relating to the prevention of CME after cataract surgery in diabetic and non-diabetic patients.

“CME remains one of the most prevalent postoperative complications in cataract surgery and especially in the diabetic population where the incidence can be as high as 31%,” Rudy MMA Nuijts, MD, PhD, Professor of Ophthalmology at the University Eye Clinic Maastricht UMC+, The Netherlands, and lead investigator of the PREMED Study, said in a news release. “This landmark study in over 1,000 patients will give us the foundation to draw up concrete evidence-based recommendations for clinical guidelines to prevent the occurrence of CME after cataract surgery in patients with and without diabetes."

Carried out at 12 surgical centers across the European Union, the PREMED Study was carefully designed to evaluate the effect of different preventive strategies on the occurrence of macular edema in 914 non-diabetic and 213 diabetic patients. All patients in the study received standard phacoemulsification for cataract and placement of an IOL. Intraoperative and postoperative antibiotics were administered according to local protocols.

In the non-diabetic population, the 914 patients received either a topical NSAID (bromfenac 0.09%) or a topical corticosteroid (dexamethasone 0.1%), or a combination of both. The primary outcome was the difference in central subfield mean macular thickness (CSMT) at 6 weeks postoperatively. Important secondary outcome measures included postoperative corrected distance visual acuity (CDVA), as well as the incidence of CME and clinically significant macular edema (CSME) within 6 and 12 weeks postoperatively.

The incidence of CSME within 12 weeks postoperatively was found to be lower in the combination treatment group (1.5%) compared to 3.6% for bromfenac alone and 5.1% for dexamethasone alone.

The 213 diabetic patients in the study were randomly allocated to receive no additional treatment, a subconjunctival injection with 40 mg triamcinolone acetonide (TA), an intravitreal injection with 1.25 mg bevacizumab, or a combination of both after cataract surgery. The main outcomes were the difference in CSMT, CDVA, and the incidence of CME and CSME within 6 and 12 weeks postoperatively.

The macular thickness and volume was found to be significantly lower in patients who received a subconjunctival injection with TA compared to patients who did not. No patient who received subconjunctival TA developed CME, while intravitreal bevacizumab had no significant effect on macular thickness.

Participating Centres

Both studies:

1 University Eye Clinic Maastricht UMC+, Maastricht University Medical Center+, Maastricht, The Netherlands

2 Zuyderland Medical Center, department of ophthalmology, Heerlen, The Netherlands

3 Vienna Institute for Research in Ocular Surgery, Hanusch Hospital, Vienna, Austria

4 Centro Hospitalar Universitário Coimbra (CHUC), department of ophthalmology, and Association for Innovation and Biomedical Research on Light (AIBILI), Coimbra, PortugalUniversity Hospital of Coimbra, Coimbra, Portugal

5 St. Elisabeth Hospital, department of ophthalmology, Tilburg, The Netherlands

6 Antwerp University Hospital and University of Antwerp, department of ophthalmology, EdegemAntwerp, Belgium

7 Medical Centre Haaglanden, department of ophthalmology, The Hague, The Netherlands

8 VU University Medical Center, department of ophthalmology, Amsterdam, The Netherlands

9 Eye Hospital Zonnestraal, Hilversum, The Netherlands

10 Hospital of the Brothers of St. John of God, department of ophthalmology, Vienna, Austria 11 Goethe University, department of ophthalmology, Frankfurt am Main, Germany

Non-diabetics only:

12 Institute of Ocular Microsurgery, Barcelona, Spain

Diabetics only:

13 Semmelweis University, department of ophthalmology, Budapest, Hungary

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