Status:
COMPLETED
The Usefulness of Visuprime in Cataract Surgery
Lead Sponsor:
VISUfarma SpA
Conditions:
Cataract
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 conjunctiva...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2022
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06533995
Start Date
October 25 2021
End Date
February 22 2022
Last Update
August 1 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Policlinico Casilino
Rome, RM, Italy, 00169
2
Clinica Fabia Mater
Rome, RM, Italy, 00171