A Phase 4 interventional study of Preservative Free drop treatment and Preserved drop treatment in Age-related Cataract, sponsored by Universitaire Ziekenhuizen KU Leuven. Recruiting at 2 sites in Belgium. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-07-01.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Phase 4, Interventional, and Treatment
Among 13 studies in Cataract with a site in Belgium — 3 open to participants now, 3 under way, none of them phase 3. Cataract · Belgium.
Among the 13 studies in Cataract with a site in Belgium, this one is one of 2 that started in 2018, is the only one in phase 4, and was the 4th registered.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
Browse Cataract studies →3 of the 13 studies in Cataract with a site in Belgium are open now. Recruiting first, the newest first:
Visionair Oogzorg · Sites in Belgium
Universitair Ziekenhuis Brussel · Sites in Belgium
A study can be open while its sites in Belgium have not opened yet or have stopped. Only those recruiting at a site in Belgium →
Of the 141 Cataract studies recruiting now, 88 (62%) set no upper age limit and 8 (6%) stop at 75 or younger; 10 take children under 18; 16 take healthy volunteers.
This study: 60 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 2 started in 2018.
This study's planned enrollment of 100 is above the median of 79 across 1,092 interventional studies indexed under Cataract.
Median enrollment 90 across the 9 interventional studies, 37 across the 4 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.
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5 of 13 have an industry lead sponsor. The 10 most frequent:
Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Universitaire Ziekenhuizen KU Leuven has 3 studies filed under Cataract — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 13 studies in Cataract with a site in Belgium, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One week before surgery, patients will be randomized to either receive the preservative-free dexamethasone 0.1% and diclofenac 0.1% eye drops.
Drug: Preservative Free drop treatment
One week before surgery, patients will be randomized to either receive the preserved dexamethasone 0.1% and diclofenac 0.1% eye drops.
Drug: Preserved 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.
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.
The superiority of treatment arm without conservative (WC) on treatment arm with conservative (C) on the aqueous flare value in the operated eye, measured with a laser flare meter, at week 4 after cataract surgery.
The Laser Flaremeter can measure the protein density in the anterior chamber by counting the photons. Flare Value is expressed in photoncount/ms. 1-9 photoncounts/ms is a normal value. Photoncount/ms from 10-500 is abnormal and indicates an inflamed eye.
Time frame: 4 weeks
Tear Osmolarity
The difference in Tear Osmolarity between the two treatment arms. Tear Osmolarity value will be measured with TearLab.
Time frame: 4 weeks
Conjunctival Hyperemia
The difference in Conjunctival Hyperemia between the two treatment arms. The scale that will be used is the Cornea and Contact Lens Research Unit (CCLRU) scale. Minimum score is 1, maximum score is 4.
Time frame: 4 weeks
Corneal Fluorescein Staining
The difference in Corneal Fluorescein Staining between the two treatment arms. The grading scale that will be used is the Oxford grading scale. Minimum score is grade 0, maximum score is grade 5.
Time frame: 4 weeks
Tear-film break up time
The difference in Tear-film break up time between the two treatment arms. The Tear-film break up time will be expressed in seconds.
Time frame: 4 weeks
Corneal Sensitivity
The difference in Corneal Sensitivity between the two treatment arms. Corneal Sensitivity value will be measured with the Cochet-Bonnet Aesthesiometer, expressed in mm.
Time frame: 4 weeks
Central macular thickness
The difference in Central Macular Thickness between the two treatment arms. Central Macular Thickness will be measured with OCT Cirrus, expressed in µm.
Time frame: 4 weeks
DEQ-5 score
The difference in Five-item Dry Eye Questionnaire (DEQ-5) score between the two treatment arms. Minimum total score is 0, maximum total score is 22.
Time frame: 4 weeks
Inflammatory cytokine activities in tears
The difference in Inflammatory cytokine activities in tears between the two treatment arms. The cytokines that will be measured are IL-1Bèta, TNF-Alpha, IL-6, IL-8, IL-17, INF γ, macrophage migration inhibitory factor,...
Time frame: 4 weeks
Amount of tears
The difference in Amount of Tears between the two treatment arms. The Amount of Tears will be measured with Schirmer tear test strips. The strips will be placed in the lower eyelid pouch for 5 minutes, value is expressed in mm.
Time frame: 4 weeks
Started Oct 2018 (actual). Primary completion is estimated for Jun 2024, 68 months after the start.
Of 39 non-industry phase 4 interventional studies under Cataract, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 39. This study's planned 68 months is above that.
Counting every sponsor, half of 46 studies reached it within 20 months; a quarter within 11 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
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