The Usefulness of Visuprime in Cataract Surgery (NCT06533995) | Clinical Trial Compass
CompletedNot Applicable
The Usefulness of Visuprime in Cataract Surgery
Italy75 participantsStarted 2021-10-25
Plain-language summary
This is a multicentre, post-market, open label, randomized, placebo-controlled prospective study exploring the performance of Visuprime in improving ocular surface homeostasis and reducing conjunctival bacterial load in patients receiving cataract surgery, as an addon treatment to postoperative standard terapy. The study will consist on 3 visits: Visit 1 (day -3 from surgery), Visit 2 (day 0, surgery), and Visit 3 (day 7 from surgery). Patients will be enrolled after having signed the informed consent form prior to any other study procedure and after inclusion/exclusion criteria check. At each visit all study procedures will be performed according to the clinical investigation plan requirements. Patients will be enrolled at Visit 1 and randomized with a 1:1 ratio to 2 groups:
GROUP A: patients receiving Visuprime eyedrop BID from day -3 to week 1. After surgery, patients will be also given standard postoperative treatment consisting on unitdose desametasone eyedrop + levofloxacin eyedrop, both given four times daily (QID) from day 0 (after surgery) to the end of the study.
GROUP B: patients receiving placebo eyedrop (the vehicle of Visuprime, i.e. isotonic buffered saline solution) BID from day -3 to week 1.
After surgery, patients will be also given standard postoperative treatment consisting on unitdose desametasone eyedrop QID + levofloxacin eyedrop QID from day 0 to the end of the study.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* At least 18 years old patients, male and female
* Previous diagnosis of cataract requiring surgery
* Wishing to participate in the study and able to sign the ICF
* No topic ophthalmic medication, including lubricating eyedrops administration for at least 4 days before screening visit.
Exclusion Criteria:
* Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g.rheumatic disease)
* Previous participation on this study for the fellow eye
* Increased risk of complicated cataract surgery according to the investigator assessment (for example presence of dilation less than 6 mm, pupil decentration, pseudoexfoliation, areas of iris atrophy, sublussation or lussation of the lens, complete cataract, sac instability, iridodonesis, systemic disease limiting intraoperative patient cooperation)
* Coexisting corneal diseases
* Past or active conjunctivitis - any type
* Past ocular surface burns
* Keratinization of the eyelid margin
* Sjogren syndrome
* History of corneal trauma
* Pregnant and lactating women
* Inability to self-administer study medications
* Know allergic sensitivity to any of the devices ingredients, or any other type of allergy
* Participation in a clinical trial during the 3 months prior to the beginning of the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
TBUT (Tear-Break-Up-Time)
Timeframe: V1 (Day -3 from surgery),V2 (Day 0, surgery), V3 (Day 7 after surgery)