The Usefulness of Visuprime in Cataract Surgery
NCT Number: NCT06533995
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cataract
Interventions: DEVICE: Visuprime|OTHER: Placebo
Sponsor: VISUfarma SpA
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2021-10-25
Completion Date: 2022-02-22
Locations: Policlinico Casilino, Rome, RM, 00169, Italy|Clinica Fabia Mater, Rome, RM, 00171, Italy

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.

Primary Outcome Measures: 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 Outcome Measures: Ocular Surface Disease Index (OSDI), Ocular Surface Disease Index will be measured at each visit and compared between the two groups.

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., V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)|Ocular Surface Disease Index (OSDI), 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., V3-V1(ten days), V2-V1(three days)|Instantaneous Non-Invasive Break-up time (iNIBUT), Instantaneous Non-Invasive Break-up time will be measured at each visit and compared between the two groups., V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)|Instantaneous Non-Invasive Break-up time (iNIBUT), 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., V3-V1(ten days), V2-V1(three days)|mean Non-Invasive Break-up time (mNIBUT), mean Non-Invasive Break-up time will be measured at each visit and compared between the two groups., V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)|mNIBUT (mean NIBUT), 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., V3-V1(ten days), V2-V1(three days)|Tear meniscus height (TMH), Tear meniscus height will be measured at each visit and compared between the two groups.

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., V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)|Tear meniscus height (TMH), 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., V3-V1 (ten days), V2-V1(three days)|Conjunctival hyperemia, 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., V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)|Corneal staining, 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., V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)|Bacterial Load, 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., V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)|VAS (Visual Analogue Scale), 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., V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)|5-point Likert Scale, 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., V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)