The Usefulness of Visuprime in Cataract Surgery

NCT ID: NCT06533995

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-25
• Study Completion Date: 2022-02-22

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 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.

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

VISUPRIME

Patients receiving Visuprime eyedrop BID from Visit 1 (day -3 from surgery) to Visit 3 (day 7 from surgery).

Group Type: EXPERIMENTAL

Visuprime

Intervention Type: DEVICE

Visuprime is a medical device (class IIa sterile) with ophtalmic indication, consisting on a 10 ml multidose bottle

Placebo

Patients receiving placebo eyedrop (the vehicle of Visuprime, ie isotonic buffered saline solution) BID from Visit 1 (day -3 from surgery) to Visit 3 (day 7 from surgery).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

placebo eyedrop isotonic buffered saline solution

Interventions

Visuprime

Visuprime is a medical device (class IIa sterile) with ophtalmic indication, consisting on a 10 ml multidose bottle

Intervention Type: DEVICE

Placebo

placebo eyedrop isotonic buffered saline solution

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VISUfarma SpA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Rita Bigioni

Role: STUDY_CHAIR

not affiliated

Locations

Policlinico Casilino

Rome, RM, Italy

Clinica Fabia Mater

Rome, RM, Italy

Countries

Italy

References

Martucci A, Zanotto E, Curtoni A, Tiezzi Appolloni A, Corsi A. The performance of an ophthalmic solution containing Poloxamer 407 and Polyquaternium 133 in reducing conjunctival bacterial load in patients receiving cataract surgery, a randomized trial. Eur J Ophthalmol. 2025 Sep 9:11206721251375236. doi: 10.1177/11206721251375236. Online ahead of print.

Reference Type: DERIVED

PMID: 40924815 (View on PubMed)

Other Identifiers

VF-OS-005/2021

Identifier Type: -

Identifier Source: org_study_id