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

NCT ID: NCT04591054

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-20
• Study Completion Date: 2022-08-24

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.

Detailed Description

Presbyopia correcting intraocular lens (PC-IOL) technology has been available for decades. Lens designs have included refractive (e.g. AMO ReZoom), apodized diffractive (e.g. Alcon Acrysof ReSTOR/PanOptix), accommodating (B&L Crystalens), and extended depth-of-focus (e.g. J&J Symfony) technology. Spectacle independence is significantly higher with PC-IOLs when compared with that of monofocal IOLs.1,2 Despite their clear benefits, PC-IOLs are not without drawbacks. Any IOL that splits light to deliver distinct distance and near foci creates the potential for photic phenomenon, which patients may perceive as glare, haloes, and starbursts.3,4

Pseudoaccommodation is defined as an increased depth-of-focus in an emmetropic eye that does not have the ability to change its refractive power. Spherical aberration, which may come from the cornea or IOL, plays an important role in pseudoaccommodation.5,6 There is a small body of literature that IOLs (e.g. Mini WELL, SIFI, Catalina, Italy) with highly-positive spherical aberration can result in significant pseudoaccommodation and lower unwanted optical phenomena than current multifocal IOLs.7

The Alcon Vivity PC-IOL is a hydrophobic acrylic, non-diffractive, extended depth of focus IOL designed for implantation in the capsular bag following cataract extraction. The single-piece IOL has a 6.0 mm diameter and has a hyper-prolate profile that extends the depth of focus to deliver a broader range of sharp vision, with the glare and halo profile approaching that of a monofocal IOL.8

The Bausch & Lomb enVista MX60E is a posterior chamber hydrophobic acrylic IOL. The single-piece IOL has a 6.0 mm diameter and has a neural aspheric optical profile. This neutral aspheric profile, combined with the cornea's natural positive spherical aberration, may extend the depth of focus relative to other negative aspheric hydrophobic acrylic monofocal IOLs on the market.

To date, there is no existing literature comparing the visual performance and patient reported outcomes of the two above mentioned lens technologies; namely, one that relies on a non-diffractive, hyper-prolate profile and another that relies on the cornea's natural positive spherical aberration to provide pseudoaccommodation.

The FDA Summary of Safety and Effectiveness on the Alcon Vivity IOL compares visual and patient reported outcomes of the Alcon Vivity IOL and the Alcon Acrysof SN60WF. While the Alcon Acrysof SN60WF and Bausch & Lomb enVista lenses are not identical, they are considered similar. The document reported improved intermediate vision with the Alcon Vivity over the SN60WF, and rates of reported visual disturbances were similar between the two devices.

Whereas the Alcon Acrysof SN60WF has a negative aspheric optical profile, the Bausch & Lomb enVista has a neutral aspheric optical profile. Theoretically, the Bausch & Lomb enVista IOL may provide increased intermediate vision compared with the SN60WF.

Conditions

Cataract; Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Extended Vision IOL

Vivity

Group Type: ACTIVE_COMPARATOR

Extended Vision IOL

Intervention Type: DEVICE

Vivity IOL implantation following cataract extraction

Neutral Aspheric Monofocal IOL

enVista \[MX60E\]

Group Type: ACTIVE_COMPARATOR

Neutral Aspheric Monofocal IOL

Intervention Type: DEVICE

enVista IOL implantation following cataract extraction

Interventions

Extended Vision IOL

Vivity IOL implantation following cataract extraction

Intervention Type: DEVICE

Neutral Aspheric Monofocal IOL

enVista IOL implantation following cataract extraction

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Symptoms that might be consistent with active COVID-19 including fever, chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches.
• If COVID-19 positive, at least two weeks since last symptoms.
• Unsuitable for study participation for any other reason, as determined by the Investigator's clinical judgement.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Seth M Pantanelli

Associate Professor of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Penn State Hershey Medical Center Eye Center

Hershey, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

15524

Identifier Type: -

Identifier Source: org_study_id