Evaluation of Vision After Vivity IOL Implantation With a Target of Slight Myopia in the Non-dominant Eye

Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the AcrySof® Vivity Intraocular Lens With a Target of Slight Myopia in the Non-dominant Eye

The objective is to assess binocular distance-corrected near (40 cm) visual acuity of patients after uneventful cataract surgery with bilateral implantation of the AcrySof® Vivity Intraocular lens (IOL) when the non-dominant eye is targeted for slight myopia.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Vivity Extended Depth of Focus intraocular lens (IOL)

Detailed Description

This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity, when the non-dominant eye is targeted for slight myopia, after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID), patient-reported spectacle independence questionnaire (PRSIQ), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity and manifest refraction.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Sebring, Florida, United States, 33870
      • Newsom Eye and Laser Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • Presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using an EDF IOL

  • Meet the requirements for on-label implantation of the EDF IOL
  • Gender: Males and Females.
  • Age: 40 or older.
  • Willing and able to provide written informed consent for participation in the study.
  • Willing and able to comply with scheduled visits and other study procedures.
  • Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract)
  • Have regular corneal astigmatism with a magnitude that can be treated with a non-toric IOL or toric IOL.
  • Have 20/32 (0.2 logMAR) or better potential acuity in both eyes

Exclusion Criteria:

• • Irregular astigmatism (e.g. keratoconus)

  • Corneal pathology (e.g. scar, dystrophy, pterygium, severe dry eye)
  • Monocular status (e.g. amblyopia)
  • Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, DSAEK, lamellar keratoplasty)
  • Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
  • Diabetic retinopathy
  • Macular pathology (e.g. ARMD, ERM)
  • History of retinal detachment
  • Subjects who have an unstable acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity.
  • Participation in any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vivity mini-monovision; Subjects will have bilateral Vivity IOL implanted, with a target of slight myopia in the non-dominant eye.	Device: Vivity Extended Depth of Focus intraocular lens (IOL); Bilateral implantation of the Vivity lens after cataract surgery, with slight myopia planned in the non-dominant eye.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular Near Visual Acuity	binocular distance-corrected near (40 cm) visual acuity at 3 months postoperative.	3 months postop

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction Accuracy	Percentage of eyes with postoperative refractive accuracy within 0.5D of target	3 months postop
Spectacle Independence	Percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire - "a little of the time" or "none of the time")	3 months postop
Patient Spectacle Independence	Patients reporting rarely or never needing glasses overall	3 months postop
Number of Participants Rating Frequency of Visual Disturbances as "Never" or "Rarely"	This is the frequency of subjects responding, "Never" or "Rarely" to a question about the frequency of glare, halos and starbursts.	3 months postop
Manifest Refraction	Manifest refraction (residual spherical equivalent refraction)	3 months postop
Residual Cylinder	Residual refractive cylinder after surgery	3 months
Uncorrected Distance Visual Acuity	Bilateral uncorrected distance visual acuity	3 months postop
Uncorrected Intermediate Visual Acuity	Bilateral uncorrected visual acuity at 66 cm	3 months postop
Uncorrected Near Visual Acuity	Bilateral uncorrected near visual acuity at 40 cm	3 months postop
Corrected Distance Visual Acuity	Bliateral corrected distance visual acuity	3 months postop
Distance Corrected Intermediate Visual Acuity	Bliateral distance corrected visual acuity at 66 cm	3 months postop

Collaborators and Investigators

• Sponsor: Newsom Eye & Laser Center
• Investigators: Principal Investigator: Thomas Newsom, MD, Newsom Eye & Laser Center

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2020
• Primary Completion (Actual): June 10, 2021
• Study Completion (Actual): June 10, 2021

Study Registration Dates

• First Submitted: July 17, 2020
• First Submitted That Met QC Criteria: July 17, 2020
• First Posted (Actual): July 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: February 9, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: TN-20-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

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.: Yes