ESCRS EPICAT Study Updates

Preliminary results of the long-awaited ESCRS EPICAT study suggest subconjunctival 10 mg triamcinolone injection could be the most effective dropless strategy for cataract surgery, with lower impact on IOP, less incidence of postoperative cystoid macular oedema (CME), and clinically significant macular oedema (CSME).

According to lead investigator Nienke Visser MD, the EPICAT study aims to find a valid alternative to periocular anti-inflammatory drug use for pseudophakic cystoid macular oedema prevention. A dropless cataract surgery can effectively cut costs and reduce treatment burden for both patients and caregivers, she said.

The European multicentred randomised clinical trial was conducted on 808 patients who underwent cataract surgery in 10 sites across 4 European countries. Patients in the control group received topical dexamethasone and bromfenac eye drops 2 days preoperatively and in a 4-week tapering scheme postoperatively. Patients in the Intervention 1 group received subconjunctival injections of 10 mg triamcinolone, while the Intervention 2 group received intracameral ketorolac added to the irrigation fluid—both during cataract surgery. Finally, the Intervention 3 group received a combination of triamcinolone and ketorolac intraoperatively.

The main study outcome is the mean change in central subfield macular thickness (CSMT) at 6 weeks compared to preoperative measures, Dr Visser said. Secondary outcomes of the study included the incidence of CME, CSME, mean corrected distance, visual acuity, and IOP. An extensive ophthalmic examination was conducted on patients at baseline, 6 weeks postoperatively, and 12 weeks postoperatively.

The results showed significantly higher mean and mean change in CSMT in the ketorolac group compared to the other groups at 6 weeks. No significant differences between groups were observed at the 12-week follow-up.

Within 12 weeks, the incidence of CME was 12.7% in the ketorolac group—significantly higher than the other three groups, Dr Visser noted. Incidence in the control group was 2.6%, 0.6% in the triamcinolone group, and 0.7% in the combined triamcinolone-ketorolac group. The incidence of CSME was also significantly higher in the ketorolac group, with 5.1% compared to 0.6% in the control and triamcinolone groups and 0% in the combined group. Escape medications due to CSME or severe anterior chamber inflammation were also 12 times more likely in the ketorolac group. Mean IOP was higher in the triamcinolone group compared to the other three groups, but, she added, the mean difference was very small. IOP spikes were irrelevant, with only 3.1% of cases in the triamcinolone group compared to 1.3% in the control group and 0% in the other groups.

The preliminary results of the ESCRS EPICAT study showed that triamcinolone 10 mg is an effective dropless strategy for the prevention of CME or CSME, with the potential to save millions in healthcare costs. Final results are expected next year, she concluded.

Dr Visser presented the findings at the 2024 ESCRS Congress in Barcelona.

Nienke Visser MD is a medical specialist at Maastricht UMC+, Netherlands. nienke.visser@mumc.nl