NCT06062771

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Fidia Farmaceutici s.p.a. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	FIDIAL PLUS	1.8% solution of sodium hyaluronate that is derived from a bacterial fermentation (not of animal origin).
DEVICE	IAL®-F	Animal derived 1.8% sodium hyaluronate equivalent to FIDIAL PLUS

Timeline

• Start date: 2022-07-23
• Primary completion: 2022-11-01
• Completion: 2023-01-01
• First posted: 2023-10-02
• Last updated: 2023-10-02

Locations

1 site across 1 country: Italy