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

January 26, 2026 updated by: Seth M Pantanelli, Milton S. Hershey Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Mature cataract in the study eye that is likely to prolong surgical procedure and/or lead to intraoperative complications prior to attempted IOL implantation.
  2. 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.
  3. Abnormal corneal findings in the study eye (e.g. keratoconus, pellucid marginal degeneration, irregular astigmatism).
  4. Any anterior segment pathology in the study eye that could significantly affect outcomes (e.g. chronic uveitis, iritis, aniridia, clinically significant corneal dystrophies, etc.)
  5. Any condition in the study eye that could affect IOL stability (e.g. pseudoexfoliation, zonular dialysis, evident zonular weakness or dehiscence, etc.).
  6. 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.
  7. History of serious corneal disease (e.g. herpes simplex, herpes zoster keratitis, etc.) in the study eye.
  8. 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.).
  9. History of cystoid macular edema in either eye.
  10. History of uveitis in either eye.
  11. History of intraocular or corneal surgery in the study eye besides laser peripheral iridotomy (LPI), selective laser trabeculoplasty (SLT), or argon laser trabeculoplasty (ALT).
  12. Uncontrolled glaucoma in the study eye (per Investigator judgement).
  13. Current ocular infection in the study eye.
  14. Presence of uncontrolled systemic disease that could increase operative risk (e.g. diabetes mellitus, mental illness, dementia, clinically significant atopic disease, etc.).
  15. Planned concomitant ocular procedure during cataract surgery inclusive of glaucoma surgery e.g. MIGS or limbal relaxing incisions.
  16. Unsuitable for study participation for any other reason, as determined by the Investigator's clinical judgement.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Johnson & Johnson Eyhance
This research is being done to investigate how patients see at far, intermediate, and near distances after cataract surgery
Device: Negative Aspheric Monofocal IOL
IOL implantation following cataract extraction
Active Comparator: Bausch & Lomb enVista.
This research is being done to investigate how patients see at far, intermediate, and near distances after cataract surgery
Device: Neutral Aspheric Monofocal IOL
IOL implantation following cataract extraction

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: 1 month post cataract surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Milton S. Hershey Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 27, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 22, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 24, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All study results

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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