The Usefulness of Visuprime in Cataract Surgery
- Conditions
- Cataract
- Interventions
- Device: VisuprimeOther: Placebo
- Registration Number
- NCT06533995
- Lead Sponsor
- VISUfarma SpA
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VISUPRIME Visuprime Patients receiving Visuprime eyedrop BID from Visit 1 (day -3 from surgery) to Visit 3 (day 7 from surgery). Placebo 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).
- Primary Outcome Measures
Name Time Method TBUT (Tear-Break-Up-Time) V3-V1 (ten days) , V2-V1(three days) 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.
- Secondary Outcome Measures
Name Time Method Ocular Surface Disease Index (OSDI) V3-V1(ten days), V2-V1(three days) The difference in the change of Ocular Surface Disease Index will be analyzed between two treatment groups at V3 compared to V1 and V2 compared to V1.
The final score is calculated which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease.mNIBUT (mean NIBUT) V3-V1(ten days), V2-V1(three days) The difference in the change of mean Non-Invasive Break-up time will be analyzed between two treatment groups at V3 compared to V1 and V2 compared to V1.
Bacterial Load V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery) Conjunctival samples collected at visit 1, visit 2 and visit 3 will be analysed to determine bacterial load which will be compared in the two study groups.
Corneal staining V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery) Corneal staining according to Oxford Scale will be measured at each visit and compared between the two groups.
The Oxford grading scale divides corneal staining into six groups according to severity from 0 (absent) to 5 (severe). The examiner compares the overall appearance of the patient's corneal staining with a reference figure, simulating the pattern of staining encountered in dry eye disease.Instantaneous Non-Invasive Break-up time (iNIBUT) V3-V1(ten days), V2-V1(three days) The difference in the change of Instantaneous Non-Invasive Break-up time will be analyzed between two treatment groups at V3 compared to V1 and V2 compared to V1.
VAS (Visual Analogue Scale) V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery) To evaluate the safety and tolerability of the Visuprime a Visual Analogue Scale will be used for overall drop comfort and ease of instillation, with the score ranges from 0 worse to 10 better and for burning and blurred vision with the score ranges from 0 better to 10 worse. These parameters will be compared in the two groups at each visit.
Tear meniscus height (TMH) V3-V1 (ten days), V2-V1(three days) The difference in the change of Tear meniscus height will be analyzed between two treatment groups at V3 compared to V1 and V2 compared to V1.
The Tear Meniscus Height is a measurement used to assess the volume of the tear film on the ocular surface useful in diagnosing dry eye conditions.
Tear Meniscus Height is assessed with Slit-lamp Biomicroscopy. Generally, the normal tear meniscus height is about 0.2-0.4 mm. Values below 0.2 mm often indicate a reduced tear volume, commonly associated with dry eye disease.Conjunctival hyperemia V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery) Conjunctival hyperemia will be measured at each visit and compared between the two groups. This parameter will be automatically graded by Keratograph according to Efron et al.:0, normal; 1, trace; 2, mild; 3, moderate.
mean Non-Invasive Break-up time (mNIBUT) V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery) mean Non-Invasive Break-up time will be measured at each visit and compared between the two groups.
5-point Likert Scale V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery) The patient satisfaction will be evaluated with a 5-point Likert Scale. The score ranges from 0 worse to 10 better.
This parameter will be compared in the two groups at each visit.
Trial Locations
- Locations (2)
Clinica Fabia Mater
🇮🇹Rome, RM, Italy
Policlinico Casilino
🇮🇹Rome, RM, Italy