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

Part of paid clinical trials in Hershey, Pennsylvania.

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT07385014
Status
Completed

Conditions

  • Cataract
  • Presbyopia

Eligibility Criteria

Sex
ALL
Age
18 Years - 95 Years
Healthy Volunteers
Not accepted

Interventions

  • Neutral Aspheric Monofocal IOL — DEVICE
    IOL implantation following cataract extraction
  • Negative Aspheric Monofocal IOL — DEVICE
    IOL implantation following cataract extraction

Study Details

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.

Key Dates

Start date
Jul 27, 2023
Status verified
Jan 2026
Primary completion
Sep 22, 2025
Completion
Oct 24, 2025

Study Design

Enrollment
80 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Johnson & Johnson Eyhance
    This research is being done to investigate how patients see at far, intermediate, and near distances after cataract surgery
  • Active Comparator: Bausch & Lomb enVista.
    This research is being done to investigate how patients see at far, intermediate, and near distances after cataract surgery

Primary Outcome Measure

Visual acuity [ Time Frame: 1 month post cataract surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
Penn State Hershey Medical CenterHersheyPennsylvania17033-

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