CataractNCT06533995
The Usefulness of Visuprime in Cataract Surgery
A study testing Visuprime in people with Cataract, run by VISUfarma SpA at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Visuprime
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 2 sitesItaly
- Study dates
- 25 Oct 2021to 22 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Policlinico Casilino
Rome, RM, 00169
Clinica Fabia Mater
Rome, RM, 00171
About this study
Official title: The Performance of Visuprime in Improving Ocular Surface Homeostasis and Reducing Conjunctival Bacterial Load in Patients Receiving Cataract Surgery
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.
Read more
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
- Being tested
- Visuprime, Placebo
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisuprimeDevice
Visuprime is a medical device (class IIa sterile) with ophtalmic indication, consisting on a 10 ml multidose bottle
PlaceboOther
placebo eyedrop isotonic buffered saline solution
| Study group | Role | What they receive |
|---|---|---|
| VISUPRIME | Experimental | Patients receiving Visuprime eyedrop BID from Visit 1 (day -3 from surgery) to Visit 3 (day 7 from surgery). Receives: 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). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: V3-V1 (ten days) , V2-V1(three days)
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start25 Oct 2021
- Primary completion22 Feb 2022
- Study completion22 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- VISUfarma SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna Rita Bigioni, Study chair, not affiliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533995
- Sponsor's protocol ID
- VF-OS-005/2021
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40924815
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Performance of Visuprime in Improving Ocular Surface Homeostasis and Reducing Conjunctival Bacterial Load in Patients Receiving Cataract Surgery
- ClinicalTrials.gov ID
- NCT06533995
- Acronym / sponsor ID
- VF-OS-005/2021
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- VISUfarma SpAIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 22 Feb 2022 (actual)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VISUPRIME | Experimental | Device: VisuprimePatients receiving Visuprime eyedrop BID from Visit 1 (day -3 from surgery) to Visit 3 (day 7 from surgery). |
| Placebo | Placebo comparator | Other: PlaceboPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VisuprimeVisuprime is a medical device (class IIa sterile) with ophtalmic indication, consisting on a 10 ml multidose bottle | Device | VISUPRIME |
| Placeboplacebo eyedrop isotonic buffered saline solution | Other | Placebo |
Primary outcome
TBUT (Tear-Break-Up-Time)
Time frame: V1 (Day -3 from surgery),V2 (Day 0, surgery), V3 (Day 7 after surgery)
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.
TBUT (Tear-Break-Up-Time)
Time frame: 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.
13 secondary outcomes
Ocular Surface Disease Index (OSDI)
Time frame: V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)
Ocular Surface Disease Index (OSDI)
Time frame: V3-V1(ten days), V2-V1(three days)
Instantaneous Non-Invasive Break-up time (iNIBUT)
Time frame: V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)
Instantaneous Non-Invasive Break-up time (iNIBUT)
Time frame: V3-V1(ten days), V2-V1(three days)
mean Non-Invasive Break-up time (mNIBUT)
Time frame: V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)
mNIBUT (mean NIBUT)
Time frame: V3-V1(ten days), V2-V1(three days)
Tear meniscus height (TMH)
Time frame: V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)
Tear meniscus height (TMH)
Time frame: V3-V1 (ten days), V2-V1(three days)
Conjunctival hyperemia
Time frame: V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)
Corneal staining
Time frame: V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)
Bacterial Load
Time frame: V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)
VAS (Visual Analogue Scale)
Time frame: V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)
5-point Likert Scale
Time frame: V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Derived from this study: PubMed 40924815Martucci 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Rita Bigioni study chair
not affiliated
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visuprime in people with Cataract, run by VISUfarma SpA at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TBUT (Tear-Break-Up-Time) (time frame: V1 (Day -3 from surgery),V2 (Day 0, surgery), V3 (Day 7 after surgery)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06533995, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.