Single-center, Double-arm, Prospective Clinical Trial to Compare Visual Performance of Non-diffractive Extended Vision and Neutral Aspheric Monofocal Intraocular Lenses

NCT04591054 | Completed Results FDA Device

• 1 other identifier: 15524
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the binocular distance, intermediate, and near visual acuity of the Alcon Vivity and Bausch \& Lomb enVista IOLs. We hypothesize that the Alcon Vivity and Bausch \& Lomb enVista IOLs will have similar distance, intermediate, and near visual acuity. If the null hypothesis is rejected, then the visual performance of the IOLs may be different.

Conditions

Cataract; Presbyopia

Keywords

extended vision; intraocular lens; presbyopia; enVista; Vivity

Outcome Measures

Primary Outcomes (1)

• Binocular Intermediate Vision

  Mean logMAR best-distance corrected visual acuity at intermediate (66 cm) tested in binocular photopic conditions at 3 months.

  3 months

Study Arms (2)

Extended Vision IOL

ACTIVE COMPARATOR

Vivity

Device: Extended Vision IOL

Neutral Aspheric Monofocal IOL

ACTIVE COMPARATOR

enVista \[MX60E\]

Device: Neutral Aspheric Monofocal IOL

Interventions

Extended Vision IOL DEVICE

Vivity IOL implantation following cataract extraction

Extended Vision IOL

Neutral Aspheric Monofocal IOL DEVICE

enVista IOL implantation following cataract extraction

Neutral Aspheric Monofocal IOL

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 eyes for which phacoemulsification cataract extraction and posterior chamber IOL implantation is indicated.
• Anticipated to undergo bilateral sequential cataract surgery
• Projected postoperative CDVA 0.20 logMAR (Snellen 20/32) or better in the study eyes, as determined by an Investigator's medical judgement.
• Calculated spherical power targeted at emmetropia at distance in the study eyes.
• Calculated IOL power between +15.0 - +25.0 D, inclusive, in both eyes.
• Measured against-the-rule astigmatism less than 0.6 D or with-the-rule/oblique astigmatism less than 1.25 D.
• 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, poor pupil dilation, 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 Eye Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Cataract; Presbyopia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Results Point of Contact

• Title: Seth Pantanelli MD
• Organization: Penn State Hershey Medical Center

spantanelli@pennstatehealth.psu.edu

717-531-4696

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Associate Professor of Ophthalmology

Model Details: single-center, double-arm, patient and assessor blinded

Study Record Dates

• First Submitted: October 11, 2020
• First Posted: October 19, 2020
• Study Start: November 20, 2020
• Primary Completion: July 26, 2022
• Study Completion: August 24, 2022
• Last Updated: August 21, 2023
• Results First Posted: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)