CClinicalTrials.gg
CompletedNCT07385014Updated Feb 3, 2026

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

An interventional study of Neutral Aspheric Monofocal IOL and Negative Aspheric Monofocal IOL in Cataract and Presbyopia, sponsored by Milton S. Hershey Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2026-02-03.

Sponsored by Milton S. Hershey Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Sep 2025, 1 year ago, and no results have been posted to the registry.
  • Registered 2 years 5 months after the study started (first participant enrolled Jul 2023, registered Jan 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 95 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cataract
  • Presbyopia

Keywords

  • intraocular lens
  • Presbyopia
  • Cataract surgery
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 80 is close to the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Milton S. Hershey Medical Center is the lead sponsor of 480 studies on the registry; 61 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 42 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
80 participants (actual)

Study 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

    Device: Negative Aspheric Monofocal IOL

  • 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

Interventions

  • DeviceNeutral Aspheric Monofocal IOL

    IOL implantation following cataract extraction

  • DeviceNegative Aspheric Monofocal IOL

    IOL implantation following cataract extraction

06

What researchers measure

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).

    Time frame: 1 month post cataract surgery

07

Study locations

1 site
  • Penn State Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
08

References and documents

Individual participant data

Plan to share: Yes — All study results

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07385014
Lead sponsor
Milton S. Hershey Medical Center
Responsible party
Seth M Pantanelli (Professor, Department of Ophthalmology, Milton S. Hershey Medical Center) — Principal investigator
First posted
Feb 3, 2026
Start date
Jul 27, 2023
Primary completion
Sep 22, 2025
Completion
Oct 24, 2025
Last update
Feb 3, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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