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

Cataract Clinical Trial

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

Clinical 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 cataract surgery.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06062771
Study type Interventional
Source Fidia Farmaceutici s.p.a.
Contact
Status Completed
Phase N/A
Start date July 23, 2022
Completion date January 1, 2023
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