The EPICAT study: Effectiveness of Periocular drug Injection in CATaract surgery

Summary: In Europe, over 4 million cataract surgeries are performed each year. A major cause of suboptimal vision following cataract surgery is cystoid macular edema (CME). In patients with CME, fluid accumulates in the central retinal area, due to leakage of blood vessels. Multiple cyst-like (cystoid) areas of fluid appear in the retina and cause retinal swelling or edema. Symptoms of CME are blurred and decreased vision. Anti-inflammatory eye drops are used after cataract surgery to prevent CME. However, noncompliance with eye drops is a major issue and may compromise the effectiveness of treatment.

Noncompliance is often unintentional and related to forgetfulness or incorrect instillation, particularly in the elderly cataract surgery population. Because many patients have difficulty with self-instillation of eye drops, formal or informal care is often required. Administrating anti-inflammatory drugs with an injection in or around the eye during cataract surgery may obviate the need for eye drops after surgery.

To investigate the effectiveness of anti-inflammatory drug delivery in or around the eye during cataract surgery, we propose to conduct a study in which 540 patients scheduled for cataract surgery will participate. Patients will be randomly divided over 3 treatment groups. One group will receive standard anti-inflammatory eye drops after cataract surgery. The other groups will receive a single or a combination of two anti-inflammatory drugs by injection in or around the eye during cataract surgery.

Before and after cataract surgery we will measure the thickness of the central area of the retina, and compare this between groups. In addition, visual acuity and quality of life will be evaluated.

We expect that administration of anti-inflammatory drugs during cataract surgery improves vision and comfort for patients and decreases costs. It may also alleviate the burden on homecare organizations.