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

Completed · Not applicable

Conditions studied: Cataract, Presbyopia

In brief

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 facts

Study ID

NCT07385014

Run by

Milton S. Hershey Medical Center

People needed

80

Starts

2023-07-27

Expected to finish

2025-10-24

Last updated by the study team

2026-02-03

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

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.
• Unsuitable for study participation for any other reason, as determined by the Investigator's clinical judgement.

Where it is running

• Penn State Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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