CataractNCT06062771
Efficacy and Safety of the Use of Ophthalmic Viscosurgical Devices (OVD) FIDIAL PLUS vs IAL®-F During Cataract Surgery
A study testing FIDIAL PLUS and IAL®-F in people with Cataract, run by Fidia Farmaceutici s.p.a. at 1 site in Italy.
Trial summary
This is a Prospective, single-center, randomized, controlled, paired-eye, single-masked clinical investigation to compare the efficacy and safety of FIDIAL PLUS (bacterial derived 1.8% sodium hyaluronate OVD) and IAL®-F (comparable animal derived 1.8% sodium hyaluronate OVD) while used during phacoemulsification… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cataract
- What is being tested?
- FIDIAL PLUS and IAL®-F
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 23 Jul 2022to 1 Jan 2023
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject able to comprehend the full nature and the purpose of the study;
- Subjects able to cooperate with the Investigator and to comply with the requirements of the entire study;
- Subject provided written informed consent to participate in the study obtained according to Good Clinical Practice (GCP);
- Females of childbearing potential (i.e., not permanently sterilised - post hysterectomy or tubal ligation status - or not postmenopausal) must have a negative urine pregnancy test result at Screening and surgery days and must use an appropriate method of contraception for at least 30 days before inclusion in the study and during the whole study period, according to the definition in ICH M3 Guideline.
- The following criteria apply to both eyes:
- Nuclear cataract with visual acuity between 20/200 (logmar 1.0) and 20/32 (logmar 0.2);
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- Intraocular pressure (IOP) between 14 and 21 mmHg (Goldmann tonometer);
- Previous refraction between -5 and +3 diopters in spherical equivalent;
- Corneas perfectly transparent without leukoma or other corneal pathology.
Who cannot join
- Any acute, chronic or uncontrolled disease as severe heart failure, recent cardiovascular event, respiratory failure, severe hepatic or renal disease, poorly controlled diabetes mellitus, active severe autoimmune disease, active malignancy etc. that in the opinion of the Investigator, would increase the risk of operation or affect the outcome of the study;
- Epilepsy and any other condition that would prevent cooperation during surgery, including head tremor, deafness, neck or back problems, restless legs syndrome, claustrophobia etc.;
- Have a history of allergic/hypersensitivity reaction to sodium hyaluronate (NaHA);
- Participation in another clinical trial within the past 30 days;
- The following criteria apply both eyes:
- Corneal endothelium cell density less than 1800 cells/mm square;
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- Pseudoexfoliation syndrome (PEX) or suspected zonular compromise of any origin;
- Corneal angle narrow or/and glaucoma;
- Anterior segment pathology likely to increase the risk of an adverse outcome for phacoemulsification cataract surgery (e.g., pseudoexfoliation syndrome, synechiae, iris atrophy, inadequate dilation, shallow anterior chamber, traumatic cataract, lens subluxation etc.);
- Any corneal irregularity or leukoma (as assessed by slit lamp and specular microscope pachymetry);
- Complicated cataracts;
- Subjects requiring implantation of toric lenses;
- Proliferative retinopathy, macular degeneration or oedema of any origin. Other ocular pathology that may compromise vision despite successful cataract surgery;
- Signs of ocular or systemic infection and/or inflammation;
- Previous intraocular surgery, refractive surgery or severe ocular trauma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single-center, Within Patient Randomized, Noninferiority, Controlled, Single-masked Clinical Investigation to Evaluate Efficacy and Safety of the Use of Ophthalmic Viscosurgical Devices (OVD) FIDIAL PLUS vs IAL®-F During Cataract Surgery
This is a Prospective, single-center, randomized, controlled, paired-eye, single-masked clinical investigation to compare the efficacy and safety of FIDIAL PLUS (bacterial derived 1.8% sodium hyaluronate OVD) and IAL®-F (comparable animal derived 1.8% sodium hyaluronate OVD) while used during phacoemulsification cataract surgery.
Read the detailed description
Viscoelastics, also referred to as OVDs (ophthalmic viscosurgical devices), are viscous substances that are routinely used in cataract surgery. The most basic benefit of OVD use in ophthalmic surgery is maintaining the anterior chamber during surgical maneuvers. One of the main aspects in OVD use remains the protection of intraocular structures and in particular of corneal endothelium cells (CECs) during cataract surgery.
- Conditions
- Cataract
- Being tested
- FIDIAL PLUS, IAL®-F
- Keywords
- Ophthalmic Viscosurgical Devices, Corneal endothelium cells, Cataract Surgery, Hyaluronic acid
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIDIAL PLUSDevice
1.8% solution of sodium hyaluronate that is derived from a bacterial fermentation (not of animal origin).
IAL®-FDevice
Animal derived 1.8% sodium hyaluronate equivalent to FIDIAL PLUS
| Study group | Role | What they receive |
|---|---|---|
| FIDIAL PLUS | Experimental | Solution of NaHA 20 mg/1.1 ml pre-filled syringe for intraocular use. 1.8% solution of sodium hyaluronate that is derived from a bacterial fermentation (not of animal origin). Receives: Device: FIDIAL PLUS |
| IAL®-F | Active comparator | Solution of NaHA 20 mg/1.1 ml pre-filled syringe for intraocular use. Animal derived 1.8% sodium hyaluronate OVD. Receives: Device: IAL®-F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of corneal endothelium cell density after phacoemulsification cataract surgery with use of two different OVD (Ophthalmic Viscosurgical Devices)
This outcome will be calculated as percentage of corneal endothelial cells loss at day 28 (T3/T6) when compared with baseline (T0). This will be assessed as a paired t-test comparing the mean percentage change of FIDIAL PLUS against the mean percentage change from baseline of IAL®-F at Day 28.
Corneal endothelial cell density will be measured by non-contact specular microscopy.
Measured: 28 days per eye
Secondary outcomes (10)
Incidence of a significant (≥30 mmHg) rise in IOP (Intraocular pressure) during study duration
This will be assessed using McNemar's test to assess the difference in proportion of eyes with a significant rise in IOP during the investigation to the proportion of eyes without a significant rise in IOP during the investigation.
IOP will be measured with Goldmann tonometer and expressed in millimeters of mercury (mmHg).
Measured: 28 days per eye
Incidence of ocular Treatment Emergent Adverse Events (TEAEs)
TEAEs are AE reported from the time of the first application of the medical device (MD).
TEAEs will be recorded and reported on the case report form (CRF). They will be tabulated by System Organ Class (SOC) and Preferred Term (PT) after medical coding using the Medical Dictionary for Regulatory Activities (MedDRA).
Measured: up to 28 days
Incidence of serious ocular Treatment Emergent Adverse Events
Serious TEAEs are AE reported from the time of the first application of the medical device (MD) that led to: death; to a serious deterioration in health that resulted in a life-threatening illness or injury, or resulted in a permanent impairment of a body structure or a body function, or required in-patient hospitalization or prolongation of existing hospitalization, or resulted in medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function; led to foetal distress, foetal death or a congenital abnormality or birth defect.
Measured: up to 28 days
Change at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6) of Intraocular pressure (IOP)
IOP will be measured with Goldmann tonometer at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6) and expressed in millimeters of mercury (mmHg).
Measured: Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6)
Central corneal Thickness changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6)
Central corneal thickness (CCT) will be measured by non-contact specular microscopy at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6)
Measured: Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6)
Incidence and grade of anterior chamber inflammation (cells and flare measurement)
Assessment of anterior chamber inflammation will be performed by slit-lamp biomicroscopy at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6).
Slit-lamp examination (SLE) will be performed before and after the instillation of dilating eye drops.
Anterior chamber (AC) inflammation will be assessed and graded according to the SUN (Standarization of Uveitis Nomenclature) clinical scoring system.
Anterior Chamber Cells grading:
Grade 0, cells in field (field size is a 1 mm by 1 mm slit beam) <1 Grade 0.5+, cells in field 1-5 Grade 1+, cells in field 6-15 Grade 2+, cells in field 16-25 Grade 4+, cells in field >50
Anterior Chamber Flare Grading:
Grade 0, none Grade 1+, Faint Grade 2+, Moderate (iris and lens details clear) Grade 3+, Marked (iris and lens details hazy) Grade 4+, Intense (fibrin or plastic acqueous)
Measured: Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6)
Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6) of corneal edema
Epithelial corneal edema will be assessed with specular microscopy at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6)
Measured: Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6)
Change at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6) of corneal endothelial morphology
It will be assessed by non-contact specular microscopy at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6).
Endothelial cell morphology will be analyzed manually or using automated measurements with the retracing method using the manufacturer's built-in image analysis software.
Measured: Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6)
Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6) of UDVA (Uncorrected distance visual acuity)
It will be measured using the Snellen chart at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6).
Visual acuity values will be expressed in decimal, fraction or logMAR. All assessments will be performed using standard charts and procedures at specified visual angle, illumination and contrast.
Measured: Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6)
Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6) of BCVA (Best corrected distance visual acuity)
It will be measured using the Snellen chart at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6).
Visual acuity values will be expressed in decimal, fraction or logMAR. All assessments will be performed using standard charts and procedures at specified visual angle, illumination and contrast.
Measured: Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start23 Jul 2022
- Primary completion1 Nov 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each eye will be randomly assigned to Test or Reference such as the subject has one eye treated with FIDIAL PLUS solution and the other with IAL-F solution. For all subjects the worst eye will be operated on first.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fidia Farmaceutici s.p.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062771
- Sponsor's protocol ID
- QQ24_20_01
- Status last verified
- Sep 2023
- First submitted
- 13 Jun 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Within Patient Randomized, Noninferiority, Controlled, Single-masked Clinical Investigation to Evaluate Efficacy and Safety of the Use of Ophthalmic Viscosurgical Devices (OVD) FIDIAL PLUS vs IAL®-F During Cataract Surgery
- ClinicalTrials.gov ID
- NCT06062771
- Acronym / sponsor ID
- QQ24_20_01
- Conditions
- Cataract
- Keywords
- Ophthalmic Viscosurgical Devices, Corneal endothelium cells, Cataract Surgery, Hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fidia Farmaceutici s.p.a.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 2 Oct 2023 (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 Prospective, single-center, randomized, controlled, paired-eye, single-masked clinical investigation to compare the efficacy and safety of FIDIAL PLUS (bacterial derived 1.8% sodium hyaluronate OVD) and IAL®-F (comparable animal derived 1.8% sodium hyaluronate OVD) while used during phacoemulsification cataract surgery.
Detailed description
Viscoelastics, also referred to as OVDs (ophthalmic viscosurgical devices), are viscous substances that are routinely used in cataract surgery. The most basic benefit of OVD use in ophthalmic surgery is maintaining the anterior chamber during surgical maneuvers. One of the main aspects in OVD use remains the protection of intraocular structures and in particular of corneal endothelium cells (CECs) during cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Each eye will be randomly assigned to Test or Reference such as the subject has one eye treated with FIDIAL PLUS solution and the other with IAL-F solution. For all subjects the worst eye will be operated on first.
| Arm | Type | Receives |
|---|---|---|
| FIDIAL PLUS | Experimental | Device: FIDIAL PLUSSolution of NaHA 20 mg/1.1 ml pre-filled syringe for intraocular use. 1.8% solution of sodium hyaluronate that is derived from a bacterial fermentation (not of animal origin). |
| IAL®-F | Active comparator | Device: IAL®-FSolution of NaHA 20 mg/1.1 ml pre-filled syringe for intraocular use. Animal derived 1.8% sodium hyaluronate OVD. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject able to comprehend the full nature and the purpose of the study;
- Subjects able to cooperate with the Investigator and to comply with the requirements of the entire study;
- Subject provided written informed consent to participate in the study obtained according to Good Clinical Practice (GCP);
- Females of childbearing potential (i.e., not permanently sterilised - post hysterectomy or tubal ligation status - or not postmenopausal) must have a negative urine pregnancy test result at Screening and surgery days and must use an appropriate method of contraception for at least 30 days before inclusion in the study and during the whole study period, according to the definition in ICH M3 Guideline.
- Nuclear cataract with visual acuity between 20/200 (logmar 1.0) and 20/32 (logmar 0.2);
Key exclusion criteria (15 listed)
- Any acute, chronic or uncontrolled disease as severe heart failure, recent cardiovascular event, respiratory failure, severe hepatic or renal disease, poorly controlled diabetes mellitus, active severe autoimmune disease, active malignancy etc. that in the opinion of the Investigator, would increase the risk of operation or affect the outcome of the study;
- Epilepsy and any other condition that would prevent cooperation during surgery, including head tremor, deafness, neck or back problems, restless legs syndrome, claustrophobia etc.;
- Have a history of allergic/hypersensitivity reaction to sodium hyaluronate (NaHA);
- Participation in another clinical trial within the past 30 days;
- Corneal endothelium cell density less than 1800 cells/mm square;
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 |
|---|---|---|
| FIDIAL PLUS1.8% solution of sodium hyaluronate that is derived from a bacterial fermentation (not of animal origin). | Device | FIDIAL PLUS |
| IAL®-FAnimal derived 1.8% sodium hyaluronate equivalent to FIDIAL PLUS | Device | IAL®-F |
Primary outcome
Change of corneal endothelium cell density after phacoemulsification cataract surgery with use of two different OVD (Ophthalmic Viscosurgical Devices)
Time frame: 28 days per eye
This outcome will be calculated as percentage of corneal endothelial cells loss at day 28 (T3/T6) when compared with baseline (T0). This will be assessed as a paired t-test comparing the mean percentage change of FIDIAL PLUS against the mean percentage change from baseline of IAL®-F at Day 28. Corneal endothelial cell density will be measured by non-contact specular microscopy.
10 secondary outcomes
Incidence of a significant (≥30 mmHg) rise in IOP (Intraocular pressure) during study duration
Time frame: 28 days per eye
Incidence of ocular Treatment Emergent Adverse Events (TEAEs)
Time frame: up to 28 days
Incidence of serious ocular Treatment Emergent Adverse Events
Time frame: up to 28 days
Change at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6) of Intraocular pressure (IOP)
Time frame: Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6)
Central corneal Thickness changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6)
Time frame: Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6)
Incidence and grade of anterior chamber inflammation (cells and flare measurement)
Time frame: Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6)
Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6) of corneal edema
Time frame: Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6)
Change at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6) of corneal endothelial morphology
Time frame: Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6)
Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6) of UDVA (Uncorrected distance visual acuity)
Time frame: Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6)
Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6) of BCVA (Best corrected distance visual acuity)
Time frame: Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6)
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 2 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIDIAL PLUS and IAL®-F in people with Cataract, run by Fidia Farmaceutici s.p.a. at 1 site 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 9 inclusion and 15 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 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Change of corneal endothelium cell density after phacoemulsification cataract surgery with use of two different OVD (Ophthalmic Viscosurgical Devices) (time frame: 28 days per eye). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2023.