ESCRS Research Projects Make a Difference

A dropless strategy with a subconjunctival 10 mg triamcinolone injection is very likely to become a standard procedure for the prevention of cystoid macular oedema (CME) after cataract surgery, with the potential to improve patient outcomes and save millions of euros in healthcare costs, as shown by the preliminary results of a European multicentre randomised trial. 

CME is a major cause of visual acuity loss following uncomplicated cataract surgery, occurring in about 5% of patients even without risk-increasing comorbidities such as diabetes. Anti-inflammatory eye drops are the current postoperative treatment to prevent CME after cataract surgery. However, low adherence to treatment due to a lack of compliance or difficulty in self-administration may seriously reduce the effectiveness of prevention while increasing the risk of developing this complication. Also, because many patients have difficulty with self-instillation of eye drops, formal or informal care is often required.

“We know from previous studies that many patients have difficulties with the self-instillation of eye drops. These patients often need informal home care, like family members or neighbours, to help them administer the eye drops,” said lead investigator Nienke Visser MD, PhD, adding that in countries with formal home care like the Netherlands, 8 to 10% of patients currently rely on this kind of assistance after cataract surgery.

Started in 2021, the Effectiveness of Periocular Drug Injection in CATaract Surgery (EPICAT) study aimed at finding a dropless strategy for CME prevention after cataract surgery, using either intra- or periocular injections, as compared to topical drugs as the control group. 

The EPICAT study evaluates three dropless strategies for CME prevention in routine cataract surgery. Main exclusion criteria were an increased risk of developing CME (e.g., diabetes), an increased risk of perioperative complications, and a history of steroid response or glaucoma. The first intervention group received a 10 mg subconjunctival injection of triamcinolone, the second intervention group received ketorolac (OMIDRIA^®) during surgery, and the third intervention group received a combination of the two during cataract surgery. Patients in the control group were treated with topical dexamethasone and bromfenac, which continued in a tapering scheme for four weeks postoperatively. In the primary results, the 10 mg triamcinolone subconjunctival injection was shown as effective as topical therapy in preventing CME after cataract surgery.

“This dropless strategy is a simple step to add to an already highly optimised cataract procedure: in the EPICAT study, we used a posterior subconjunctival injection 6.0 mm from the limbus in the inferotemporal quadrant of the conjunctiva to administer 0.25 mL of a 40 mg/mL triamcinolone solution,” Dr Visser explained. “We expect this to be a game changer that only takes one minute out of the surgical time, with the added benefit of relieving patients of postoperative eye drops.”

New cataract surgery guidelines

Final EPICAT study results are expected to be taken into serious consideration by ESCRS and will surely be integrated into the upcoming cataract surgery guidelines.

“This study is pivotal for the ESCRS because it addresses one of the most pressing challenges in cataract surgery,” said Joaquin Fernández MD, PhD. “Its results already have several important implications for both patients and the field of ophthalmology.”

ESCRS became involved in the EPICAT study through its Clinical Research Award (CRA), a key Society initiative to support multinational interventional studies with a focus on cataract surgery. ESCRS awarded the EPICAT team €749,707 and started to work closely with the team to oversee the project’s progression. This included monitoring key milestones, approving protocol amendments, and ensuring the study remained on budget and met its objectives, Professor Fernández pointed out.

“It has been a challenge to complete this study during the COVID pandemic with all the issues related to patient inclusion and drug procurement. We were hesitant if this was going to happen,” co-investigator Rudy MMA Nuijts MD, PhD told EuroTimes. “Now, it is important to see how these results will get implemented into daily practice.”

Preliminary results were presented at the 2024 ESCRS Congress in Barcelona. According to Prof Fernández, the trial has the potential to transform cataract surgery, particularly in how postoperative inflammation and complications like CME are managed.

In Europe, its findings provide a strong case for adopting a streamlined, dropless approach to cataract surgery. Since it is a cost-effective, minimally invasive protocol that benefits both high- and low-resource settings, this strategy aligns with the global healthcare goals of improving outcomes while controlling costs. It establishes a new benchmark for postoperative inflammation management, impacting millions of patients worldwide.

Building on this progress, the team hope to deliver the final results to the ESCRS by the end of 2025. Simultaneously, the first article based on these findings is expected to be submitted for publication very soon, Prof Fernández noted.

Moreover, further publications are planned, including a detailed analysis of the health economics associated with the EPICAT study. The next step is to dive into the procedure’s cost-effectiveness and the vision-related quality-of-life gains. This is part of the EPICAT team’s comprehensive approach to ensure the findings are robust, actionable, and beneficial for the broader ophthalmic community.

The results of EPICAT are not only promising for CME prevention. According to both Dr Visser and Prof Fernández, there is a vast potential for applications in complicated cases, even outside cataract surgery. As the PREvention of Macular EDema after cataract surgery (PREMED) study published by Laura Wilders MD, PhD and Prof Nuijts showed, a subconjunctival injection of a higher 40 mg triamcinolone dose was effective in preventing CME in patients with diabetic retinopathy. 

“After the PREMED study, we had a long deliberation process to see which dose we would use to prevent a pressure spike due to steroids, ending up with the 10 mg dose,” Prof Nuijts added.

Dr Visser and Prof Nuijts noted the PREMED and EPICAT findings could hint at a good rationale in considering further studies for the use of triamcinolone in other surgical fields that involve postoperative inflammation and are therefore prone to CME (especially retinal surgery) and in patients with epiretinal membranes, BRVO, uveitis, and diabetes. Proactively addressing inflammation, as demonstrated by the EPICAT study, could inspire similar dropless strategies to avoid complications and enhance patient outcomes.

Research pipeline

ESCRS’s commitment to advancing evidence-based medicine and research through various awards programmes effectively encourages an exciting pipeline of ongoing and upcoming studies.

There are currently two active CRA-funded trials and three nearing completion, including high-profile projects like ETCF, which compares the outcomes of triple-DMEK with cataract surgery in patients with Fuchs’ endothelial corneal dystrophy; METACOR-2, which aims to model the corneal microbiome to better identify pathogenic microorganisms; MYOPRED, which investigates the impact of posterior vitreous detachment on RD after lens surgery in myopic eyes; and finally TORIC, which evaluates the effectiveness and cost-effectiveness of toric IOL implantation in patients with mild astigmatism.

Prof Fernández said the ESCRS is actively working to expand its research initiatives, with plans to announce a new clinical research award in 2025. “It’s a way to look ahead and further strengthen our ability to fund innovative and high-impact studies.”

Nienke Visser MD, PhD is the EPICAT lead investigator and medical specialist at Maastricht UMC+, Netherlands. nienke.visser@mumc.nl

Rudy MMA Nuijts MD, PhD is Full Professor of Ophthalmology and Director of the Cornea Clinic and the Centre for Refractive Surgery at the Department of Ophthalmology, University of Maastricht, Netherlands. rudy.nuijts@mumc.nl

Joaquín Fernández Pérez MD, PhD is the CEO and Medical Director in the Ophthalmology Department at Qvisión in Vithas Virgen del Mar Hospital, Almería, Spain. He is incoming Secretary of the ESCRS and outgoing leader of the ESCRS Research Committee. joaquinfernandezoft@qvision.es