search
Back to results

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

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vivity Extended Depth of Focus intraocular lens (IOL)
Sponsored by
Newsom Eye & Laser Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Newsom Eye and Laser Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vivity mini-monovision

Arm Description

Subjects will have bilateral Vivity IOL implanted, with a target of slight myopia in the non-dominant eye.

Outcomes

Primary Outcome Measures

Binocular Near Visual Acuity
binocular distance-corrected near (40 cm) visual acuity at 3 months postoperative.

Secondary Outcome Measures

Prediction Accuracy
Percentage of eyes with postoperative refractive accuracy within 0.5D of target
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")
Patient Spectacle Independence
Patients reporting rarely or never needing glasses overall
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.
Manifest Refraction
Manifest refraction (residual spherical equivalent refraction)
Residual Cylinder
Residual refractive cylinder after surgery
Uncorrected Distance Visual Acuity
Bilateral uncorrected distance visual acuity
Uncorrected Intermediate Visual Acuity
Bilateral uncorrected visual acuity at 66 cm
Uncorrected Near Visual Acuity
Bilateral uncorrected near visual acuity at 40 cm
Corrected Distance Visual Acuity
Bliateral corrected distance visual acuity
Distance Corrected Intermediate Visual Acuity
Bliateral distance corrected visual acuity at 66 cm

Full Information

First Posted
July 17, 2020
Last Updated
February 9, 2022
Sponsor
Newsom Eye & Laser Center
search

1. Study Identification

Unique Protocol Identification Number
NCT04482439
Brief Title
Evaluation of Vision After Vivity IOL Implantation With a Target of Slight Myopia in the Non-dominant Eye
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 17, 2020 (Actual)
Primary Completion Date
June 10, 2021 (Actual)
Study Completion Date
June 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Newsom Eye & Laser Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model 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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vivity mini-monovision
Arm Type
Experimental
Arm Description
Subjects will have bilateral Vivity IOL implanted, with a target of slight myopia in the non-dominant eye.
Intervention Type
Device
Intervention Name(s)
Vivity Extended Depth of Focus intraocular lens (IOL)
Intervention Description
Bilateral implantation of the Vivity lens after cataract surgery, with slight myopia planned in the non-dominant eye.
Primary Outcome Measure Information:
Title
Binocular Near Visual Acuity
Description
binocular distance-corrected near (40 cm) visual acuity at 3 months postoperative.
Time Frame
3 months postop
Secondary Outcome Measure Information:
Title
Prediction Accuracy
Description
Percentage of eyes with postoperative refractive accuracy within 0.5D of target
Time Frame
3 months postop
Title
Spectacle Independence
Description
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")
Time Frame
3 months postop
Title
Patient Spectacle Independence
Description
Patients reporting rarely or never needing glasses overall
Time Frame
3 months postop
Title
Number of Participants Rating Frequency of Visual Disturbances as "Never" or "Rarely"
Description
This is the frequency of subjects responding, "Never" or "Rarely" to a question about the frequency of glare, halos and starbursts.
Time Frame
3 months postop
Title
Manifest Refraction
Description
Manifest refraction (residual spherical equivalent refraction)
Time Frame
3 months postop
Title
Residual Cylinder
Description
Residual refractive cylinder after surgery
Time Frame
3 months
Title
Uncorrected Distance Visual Acuity
Description
Bilateral uncorrected distance visual acuity
Time Frame
3 months postop
Title
Uncorrected Intermediate Visual Acuity
Description
Bilateral uncorrected visual acuity at 66 cm
Time Frame
3 months postop
Title
Uncorrected Near Visual Acuity
Description
Bilateral uncorrected near visual acuity at 40 cm
Time Frame
3 months postop
Title
Corrected Distance Visual Acuity
Description
Bliateral corrected distance visual acuity
Time Frame
3 months postop
Title
Distance Corrected Intermediate Visual Acuity
Description
Bliateral distance corrected visual acuity at 66 cm
Time Frame
3 months postop

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Newsom, MD
Organizational Affiliation
Newsom Eye & Laser Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Newsom Eye and Laser Center
City
Sebring
State/Province
Florida
ZIP/Postal Code
33870
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs