NCT07385014

MULTICENTER, DOUBLE-ARM, PATIENT AND ASSESSOR-MASKED, PROSPECTIVE, RANDOMIZED CLINICAL TRIAL TO COMPARE VISUAL PERFORMANCE OF NEGATIVE AND NEUTRAL ASPHERIC MONOFOCAL INTRAOCULAR LENSES

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the binocular distance, intermediate, and near visual acuity and patient reported outcomes of the Johnson \&Johnson Eyhance and Bausch \& Lomb enVista IOLs. We hypothesize that the Johnson \& Johnson's Eyhance and Bausch \& Lomb enVista IOLs will have similar distance, intermediate, and near visual acuity.

Detailed description

This research is being done to investigate how patients see at far, intermediate, and near distances after cataract surgery with one of two intraocular lenses: Johnson \& Johnson Eyhance or Bausch \& Lomb enVista. Note that neither of these lenses are considered investigational devices; both lenses are FDA approved in the United States for implantation during cataract surgery.

Conditions

• Cataract
• Presbyopia

Interventions

Type	Name	Description
DEVICE	Neutral Aspheric Monofocal IOL	IOL implantation following cataract extraction
DEVICE	Negative Aspheric Monofocal IOL	IOL implantation following cataract extraction

Timeline

• Start date: 2023-07-27
• Primary completion: 2025-09-22
• Completion: 2025-10-24
• First posted: 2026-02-03
• Last updated: 2026-02-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study