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
| NCT ID | NCT04050644 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Age-related Cataract |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2018-10-30 |
| Primary Completion | 2024-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2018-10-30 with a primary completion date of 2024-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Heleen Delbeke, MD
PRINCIPAL INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Frequently Asked Questions
Who can join the NCT04050644 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Age-related Cataract. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04050644 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04050644 currently recruiting?
Yes, NCT04050644 is actively recruiting participants. Contact the research team at heleen.delbeke@uzleuven.be for enrollment information.
Where is the NCT04050644 trial being conducted?
This trial is being conducted at Leuven, Belgium, Roeselare, Belgium.
Who is sponsoring the NCT04050644 clinical trial?
NCT04050644 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Heleen Delbeke, MD at Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 100 participants.