NCT04050644

Comparison of Treatment With Preservative-free Dexamethasone 0.1% (Monofree Dexamethason) and Diclofenac 0.1% (Dicloabak) Eye Drops Versus Preserved Dexamethasone 0.1% (Maxidex) and Diclofenac 0.1% (Voltaren Ophtha) Eye Drops After Cataract Surgery

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

To compare treatment with preservative-free dexamethasone 0.1% (Monofree Dexamethason) and diclofenac 0.1% (Dicloabak) eye drops versus preserved dexamethasone 0.1% (Maxidex) and diclofenac 0.1% (Voltaren Ophtha) eye drops after cataract surgery in terms of postoperative inflammation, iatrogenic dry eye disease and cystoid macular edema.

Detailed description

Cataract surgery is a standardized procedure yielding excellent visual outcomes in most patients. According to Daien et al., the incidence of cataract surgery in 2012 in France was 11/1000 person-years. Although there are few complications related to the surgery, patients often experience ocular discomfort in the postoperative period. Postoperative treatment usually includes topical non-steroidal anti-inflammatory drugs and topical steroids for four weeks to control anterior chamber inflammation, to relieve ocular pain after surgery and to reduce the incidence of cystoid macular edema. Benzalkonium chloride (BAK) is the most common eye drop preservative and is associated with several ocular adverse effects, including dry eye and ocular surface inflammation. Moreover, in two clinical trials comparing the effects of BAK-containing and preservative-free eye drops, anterior chamber inflammation was reported in response to BAK after 1 month of exposure. Finally, besides the fact that intra-ocular inflammation increases the risk of macular edema, there is some evidence in the literature suggesting that BAK may also contribute to the development of macular edema. Because of these well-established detrimental effects of preservatives, pharmaceutical industry has invested in the development of preservative-free eye drops in the past decade, which has led to preservative-free alternatives for almost all the eye medications. The aim of this project is to investigate whether omitting preservatives from the postoperative topical treatment after cataract surgery can reduce symptoms and signs of ocular surface disease, intra-ocular inflammation and the incidence of cystoid macular edema. Additionally ocular microbiome research is added to our study because of its known correlation with the ocular immunity. Although the ocular surface is continuously colonized by a commensal microbial community, the healthy ocular surface is not in an inflammatory state. This phenomenon suggests that there is an interplay between the ocular surface microbiome and innate immune mechanisms, which prevents inflammatory responses against commensal microbiota. St Leger et al. used a murine model to reveal the presence of a commensal, Corynebacterium mastitidis, on the ocular surface. Corynebacterium mastitidis elicited an IL-17 response from ƔΔT-cells, facilitating recruitment of neutrophils to the ocular surface and secretion of antimicrobial peptides in the tears. These findings suggest the presence of a functional resident microbiome on the ocular surface which contribute to immune homeostasis and protects the ocular surface from pathogens. Our expert in the area of ocular microbiome research is affiliated with the department of biochemistry and microbiology of the University of Ghent.

Conditions

• Age-related Cataract

Interventions

Type	Name	Description
DRUG	Preservative Free drop treatment	Patients will use the preservative-free dexamethasone 0.1% 4 times a day in the first week after cataract surgery, 3 times a day in the second week, twice daily in the third week and once daily in the fourth week and diclofenac 0.1% eye drops 3 times daily for 1 day preoperatively and every 15 minutes in the hour before surgery and then 3 times a day for four weeks.
DRUG	Preserved drop treatment	Patients will use the preserved dexamethasone 0.1% 4 times a day in the first week after cataract surgery, 3 times a day in the second week, twice daily in the third week and once daily in the fourth week and diclofenac 0.1% eye drops 3 times daily for 1 day preoperatively and every 15 minutes in the hour before surgery and then 3 times a day for four weeks.

Timeline

• Start date: 2018-10-30
• Primary completion: 2024-06-01
• Completion: 2024-12-01
• First posted: 2019-08-08
• Last updated: 2024-07-01

Locations

2 sites across 1 country: Belgium