NCT06479148

Clinical Evaluation of the Performance of the enVista® Aspire™ (EA) Lens

A Prospective, Single-Center, Randomized Clinical Investigation to Evaluate the Performance of enVista® Aspire ™ (EA) Intraocular Lens Against a Control and an Active-Comparator in Subjects Undergoing Cataract Extraction and Implantation of an Intraocular Lens

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

A Prospective, Single-Center, Randomized Clinical Investigation to evaluate the safety and performance of the enVista® Aspire ™ (EA) intraocular lens (IOL) when compared to the MX60E monofocal IOL (control lens) and an IOL with a slightly extended depth of focus (active comparator lens) for potentially improved optical properties.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	enVista® Aspire™	Eyes will receive enVista® Aspire™ lenses
DEVICE	An IOL with a slightly extended depth of focus	Eyes will receive lenses with a slightly extended depth of focus
DEVICE	MX60E	Eyes will receive MX60E lenses

Timeline

• Start date: 2024-08-15
• Primary completion: 2024-12-12
• Completion: 2024-12-12
• First posted: 2024-06-28
• Last updated: 2024-12-27

Locations

1 site across 1 country: Honduras

Regulatory

• FDA-regulated device study