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

NCT07385014 | Completed FDA Device

• 1 other identifier: 21065
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cataract; Presbyopia

Keywords

intraocular lens; Presbyopia; Cataract surgery

Outcome Measures

Primary Outcomes (1)

• Visual acuity

  Mean logMAR best-distance corrected visual acuity at intermediate (66 cm) tested in binocular photopic conditions at 1 month (binocular DCIVA).

  1 month post cataract surgery

Study Arms (2)

Johnson & Johnson Eyhance

ACTIVE COMPARATOR

This research is being done to investigate how patients see at far, intermediate, and near distances after cataract surgery

Device: Negative Aspheric Monofocal IOL

Bausch & Lomb enVista.

ACTIVE COMPARATOR

This research is being done to investigate how patients see at far, intermediate, and near distances after cataract surgery

Device: Neutral Aspheric Monofocal IOL

Interventions

Neutral Aspheric Monofocal IOL DEVICE

IOL implantation following cataract extraction

Bausch & Lomb enVista.

Negative Aspheric Monofocal IOL DEVICE

IOL implantation following cataract extraction

Johnson & Johnson Eyhance

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age 18 or older at the time of study enrollment.
• Visually significant cataract in the study eye for which phacoemulsification cataract extraction and posterior chamber IOL implantation is indicated.
• Projected postoperative CDVA 0.20 logMAR (Snellen 20/32) or better in the study eye, as determined by an Investigator's medical judgement.
• Calculated spherical power targeted at emmetropia at distance in the study eyes.
• Calculated IOL power between +5.0 - +34.0 D, inclusive, in both eyes.
• Measured keratometric astigmatism less than 1.0 D if against-the-rule or 1.5 D if with-the-rule/oblique.
• If wearing rigid gas permeable (RGP) contact lens in the study eye, willingness to discontinue lens wear for ≥ 21 days prior to preoperative biometry.
• Availability, willingness, and sufficient cognitive awareness to return for study-required visits and comply with examination procedures.
• Willingness to sign the IRB-approved informed consent form (ICF) for study participation.

You may not qualify if:

• Mature cataract in the study eye that is likely to prolong surgical procedure and/or lead to intraoperative complications prior to attempted IOL implantation.
• Any visually significant intraocular media opacity other than cataract in the study eye (as determined by the investigator). Such opacities might include corneal scar or vitreous hemorrhage.
• Abnormal corneal findings in the study eye (e.g. keratoconus, pellucid marginal degeneration, irregular astigmatism).
• Any anterior segment pathology in the study eye that could significantly affect outcomes (e.g. chronic uveitis, iritis, aniridia, clinically significant corneal dystrophies, etc.)
• Any condition in the study eye that could affect IOL stability (e.g. pseudoexfoliation, zonular dialysis, evident zonular weakness or dehiscence, etc.).
• History of severe dry eye in the study eye that, in the judgement of the investigator, would impair the ability to obtain reliable study measurements.
• History of serious corneal disease (e.g. herpes simplex, herpes zoster keratitis, etc.) in the study eye.
• History of any clinically significant retinal pathology or ocular diagnosis in the study eye that could, in the investigator's best judgement, alter or limit final post-operative visual prognosis (e.g. diabetic retinopathy, ischemic disease, macular degeneration, retinal detachment, optic neuropathy, amblyopia, strabismus, aniridia, epiretinal membrane, etc.).
• History of cystoid macular edema in either eye.
• History of uveitis in either eye.
• History of intraocular or corneal surgery in the study eye besides laser peripheral iridotomy (LPI), selective laser trabeculoplasty (SLT), or argon laser trabeculoplasty (ALT).
• Uncontrolled glaucoma in the study eye (per Investigator judgement).
• Current ocular infection in the study eye.
• Presence of uncontrolled systemic disease that could increase operative risk (e.g. diabetes mellitus, mental illness, dementia, clinically significant atopic disease, etc.).
• Planned concomitant ocular procedure during cataract surgery inclusive of glaucoma surgery e.g. MIGS or limbal relaxing incisions.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Cataract; Presbyopia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Ophthalmology

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: July 27, 2023
• Primary Completion: September 22, 2025
• Study Completion: October 24, 2025
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)