NCT05158699

Effectiveness of Periocular Drug Injection in CATaract Surgery

The ESCRS EPICAT Study: Effectiveness of Periocular Drug Injection in CATaract Surgery

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 628 (actual)
• Sponsor: Luigi Rondas · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Cystoid macular edema (CME) is a major cause of suboptimal postoperative visual acuity after cataract surgery. Topical steroidal and nonsteroidal anti-inflammatory drugs (NSAIDs) are used to prevent CME. However, noncompliance with eye drops may compromise the effectiveness of treatment. Dropless periocular drug delivery during cataract surgery may improve the outcomes and cost-effectiveness of cataract surgery, and may alleviate the burden on homecare organizations.

Detailed description

In a recent European multicentre study (PREvention of Macular EDema after cataract surgery; PREMED), it was demonstrated that the combination of topical corticosteroids and NSAIDs results in the lowest risk of developing CME after cataract surgery. However, noncompliance with eye drops may compromise the effectiveness of treatment. Noncompliance is often unintentional and related to forgetfulness or incorrect instillation, particularly in the elderly cataract surgery population. The objective of this study is to evaluate the effectiveness of different treatments to prevent CME after cataract surgery, using either topical drugs (control group) or intra-/periocular injections (intervention groups). The hypothesis of this study is that intra-/periocular anti-inflammatory drug delivery during cataract surgery is effective in preventing CME, with better health-related quality of life and improved cost-effectiveness compared to standard topical drug delivery. The primary outcome measure is the change in central subfield mean macular thickness (CSMT) at 6 weeks postoperatively as compared to baseline. Secondary outcome measures are the incidence of CME; the incidence of clinically significant macular edema (CSME); mean corrected distance visual acuity (CDVA); para- and perifoveal thickness and total macular volume (TMV); intraocular pressure (IOP); anterior chamber inflammation; vision-related quality of life; and cost-effectiveness. The design of this study is a European randomised controlled multicenter trial. The study population will consist of 808 patients aged 21 years or older who require cataract surgery in at least one eye. Patients with a foreseen increased risk of developing CME or ophthalmic disorders other than cataract will be excluded. Follow-up duration is 12 weeks. The study will be conducted over a period of 36 months.

Conditions

• Macular Edema
• Cystoid Macular Edema
• Retinal Disease
• Cataract
• Lens Diseases
• Eye Diseases

Interventions

Type	Name	Description
DRUG	Bromfenac	Bromfenac topical eye drops (Yellox)
DRUG	Dexamethasone	Dexamethasone topical eye drops
DRUG	Triamcinolone Acetonide	0.25ml of 40mg/ml (10mg) triamcinolone acetonide (Triesence/Vistrec) will be injected subconjunctivally
DRUG	Ketorolac-Phenylephrine Ophthalmic 0.3%-1% Intraocular Solution	Omidria is added to the irrigation fluid used during cataract surgery. At the end of surgery, the anterior chamber will be filled with the ketorolac solution.

Timeline

• Start date: 2021-10-13
• Primary completion: 2024-08-13
• Completion: 2024-08-13
• First posted: 2021-12-15
• Last updated: 2024-11-04

Locations

10 sites across 4 countries: Austria, Germany, Netherlands, Portugal