Comparison of preservative-free and preserved eye drops after cataract surgery
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
This study is testing if using preservative-free eye drops after cataract surgery helps older patients recover better than using regular eye drops with preservatives.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 2 sites (Leuven, Vlaams-Brabant and 1 other locations) |
| Trial ID | NCT04050644 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of preservative-free dexamethasone and diclofenac eye drops against their preserved counterparts following cataract surgery. The focus is on evaluating postoperative inflammation, dry eye disease, and cystoid macular edema. Patients aged 60 and older diagnosed with age-related cataract will be enrolled, and their recovery will be monitored to assess the impact of preservative-free treatments. The study aims to determine if avoiding preservatives can lead to better postoperative outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients aged 60 years or older diagnosed with age-related cataract.
Not a fit: Patients with pre-existing dry eye disease or other ocular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery and reduced ocular discomfort for patients undergoing cataract surgery.
How similar studies have performed: Previous studies have indicated that preservative-free eye drops can reduce ocular surface inflammation, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed with age-related cataract * Age 60 years or above Exclusion Criteria: * Unwilling to sign informed consent * Pseudoexfoliation syndrome * Functionally monocular patient * Any use of eye drops during at least 3 months before surgery with the exception of artificial tears * Pre-existing dry eye disease according to the criteria's of the TFOS DEXS II report * Previous ocular surgery, laser treatment or uveitis, with the exception of retinal laser treatment (more than 6 months ago) and iridotomy (more than 6 months ago) * Active conjunctivitis * Wearing of contact lens * Presence of any macular diseases possibly impacting visual acuity * Presence of any ocular diseases leading to difficulty to have a correct eye examination * Known or suspected allergy to any of the ingredients on the study medications * Presence of uncontrolled systemic disease
Where this trial is running
Leuven, Vlaams-Brabant and 1 other locations
- Universitaire Ziekenhuizen Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
- AZ Delta — Roeselare, West-Vlaanderen, Belgium (Recruiting)
Study contacts
- Principal investigator: Heleen Delbeke, MD — Universitaire Ziekenhuizen KU Leuven
- Study coordinator: Heleen Delbeke, MD
- Email: heleen.delbeke@uzleuven.be
- Phone: +32 16 332687
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.