Clinical trial NCT06062771: Efficacy and Safety of the Use of Ophthalmic Viscosurgical Devices (OVD) FIDIAL PLUS vs IAL®-F During Cataract Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Ophthalmic Viscosurgical Devices
Corneal endothelium cells
Cataract Surgery
Hyaluronic acid
Lead sponsor: Fidia Farmaceutici s.p.a.
Sponsor class: INDUSTRY
First posted: 2023-10-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. Subject able to comprehend the full nature and the purpose of the study;
2. Subjects able to cooperate with the Investigator and to comply with the requirements of the entire study;
3. Subject provided written informed consent to participate in the study obtained according to Good Clinical Practice (GCP);
4. 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:

1. Nuclear cataract with visual acuity between 20/200 (logmar 1.0) and 20/32 (logmar 0.2);
2. Intraocular pressure (IOP) between 14 and 21 mmHg (Goldmann tonometer);
3. Previous refraction between -5 and +3 diopters in spherical equivalent;
4. Corneas perfectly transparent without leukoma or other corneal pathology.

Exclusion Criteria:

1. 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;
2. Epilepsy and any other condition that would prevent cooperation during surgery, including head tremor, deafness, neck or back problems, restless legs syndrome, claustrophobia etc.;
3. Have a history of allergic/hypersensitivity reaction to sodium hyaluronate (NaHA);
4. Participation in another clinical trial within the past 30 days;

The following criteria apply both eyes:

1. Corneal endothelium cell density less than 1800 cells/mm square;
2. Pseudoexfoliation syndrome (PEX) or suspected zonular compromise of any origin;
3. Corneal angle narrow or/and glaucoma;
4. 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.);
5. Any corneal irregularity or leukoma (as assessed by slit lamp and specular microscope pachymetry);
6. Complicated cataracts;
7. Subjects requiring implantation of toric lenses;
8. Proliferative retinopathy, macular degeneration or oedema of any origin. Other ocular pathology that may compromise vision despite successful cataract surgery;
9. Signs of ocular or systemic infection and/or inflammation;
10. Previous intraocular surgery, refractive surgery or severe ocular trauma.

Primary outcomes:
measure: Change of corneal endothelium cell density after phacoemulsification cataract surgery with use of two different OVD (Ophthalmic Viscosurgical Devices)
timeFrame: 28 days per eye
Secondary outcomes:
measure: Incidence of a significant (≥30 mmHg) rise in IOP (Intraocular pressure) during study duration
timeFrame: 28 days per eye
measure: Incidence of ocular Treatment Emergent Adverse Events (TEAEs)
timeFrame: up to 28 days
measure: Incidence of serious ocular Treatment Emergent Adverse Events
timeFrame: up to 28 days
measure: Change at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6) of Intraocular pressure (IOP)
timeFrame: Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6)
measure: Central corneal Thickness changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6)
timeFrame: Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6)
measure: Incidence and grade of anterior chamber inflammation (cells and flare measurement)
timeFrame: Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6)
measure: Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6) of corneal edema
timeFrame: Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6)
measure: Change at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6) of corneal endothelial morphology
timeFrame: Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6)
measure: Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6) of UDVA (Uncorrected distance visual acuity)
timeFrame: Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6)
measure: Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6) of BCVA (Best corrected distance visual acuity)
timeFrame: Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6)
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata di Verona
Study officials:
References: