Efficacy and Safety of the Use of Ophthalmic Viscosurgical Devices (OVD) FIDIAL PLUS vs IAL®-F During Cataract Surgery

NCT06062771 | Completed

• 1 other identifier: QQ24_20_01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

Ophthalmic Viscosurgical Devices; Corneal endothelium cells; Cataract Surgery; Hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• 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.

  28 days per eye

Secondary Outcomes (10)

• Incidence of a significant (≥30 mmHg) rise in IOP (Intraocular pressure) during study duration

  28 days per eye

• Incidence of ocular Treatment Emergent Adverse Events (TEAEs)

  up to 28 days

• Incidence of serious ocular Treatment Emergent Adverse Events

  up to 28 days

• Change at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6) of Intraocular pressure (IOP)

  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)

  Changes at day 1 (T1/T4), day 7 (T2/T5) and day 28 (T3/T6)

Study Arms (2)

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).

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.

Device: IAL®-F

Interventions

FIDIAL PLUS DEVICE

1.8% solution of sodium hyaluronate that is derived from a bacterial fermentation (not of animal origin).

FIDIAL PLUS

IAL®-F DEVICE

Animal derived 1.8% sodium hyaluronate equivalent to FIDIAL PLUS

IAL®-F

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• The following criteria apply to both eyes:
• Nuclear cataract with visual acuity between 20/200 (logmar 1.0) and 20/32 (logmar 0.2);
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Fidia Farmaceutici s.p.a.: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, 37126, Italy

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: October 2, 2023
• Study Start: July 23, 2022
• Primary Completion: November 1, 2022
• Study Completion: January 1, 2023
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

IT (1)