The Usefulness of Visuprime in Cataract Surgery

NCT06533995 | Completed

• 1 other identifier: VF-OS-005/2021
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• TBUT (Tear-Break-Up-Time)

  To evaluate the performance of the Visuprime, used in improving ocular surface homeostasis in patients receiving cataract surgery, fluorescein tear break-up time will be measured and compared in the two groups at each visit.

  V1 (Day -3 from surgery),V2 (Day 0, surgery), V3 (Day 7 after surgery)

• TBUT (Tear-Break-Up-Time)

  To evaluate the performance of the Visuprime, used in improving ocular surface homeostasis in patients receiving cataract surgery, the difference in the change of Tear Break-Up Time test will be analyzed between two treatment groups at V3 compared to V1 and at V2 compared to V1.

  V3-V1 (ten days) , V2-V1(three days)

Secondary Outcomes (13)

• Ocular Surface Disease Index (OSDI)

  V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)

• Ocular Surface Disease Index (OSDI)

  V3-V1(ten days), V2-V1(three days)

• Instantaneous Non-Invasive Break-up time (iNIBUT)

  V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)

• Instantaneous Non-Invasive Break-up time (iNIBUT)

  V3-V1(ten days), V2-V1(three days)

• mean Non-Invasive Break-up time (mNIBUT)

  V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)

Study Arms (2)

VISUPRIME

EXPERIMENTAL

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

Device: Visuprime

Placebo

PLACEBO COMPARATOR

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).

Other: Placebo

Interventions

Visuprime DEVICE

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

VISUPRIME

Placebo OTHER

placebo eyedrop isotonic buffered saline solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VISUfarma SpA: lead

Study Sites (2)

Policlinico Casilino

Rome, RM, 00169, Italy

Location

Clinica Fabia Mater

Rome, RM, 00171, Italy

Location

Related Publications (1)

• 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.

  PMID: 40924815 DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Anna Rita Bigioni

  not affiliated

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: August 1, 2024
• Study Start: October 25, 2021
• Primary Completion: February 22, 2022
• Study Completion: February 22, 2022
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)