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

Sponsor
Newsom Eye & Laser Center (Other)
Overall Status
Completed
CT.gov ID
NCT04482439
Collaborator
(none)
35
Enrollment
1
Location
1
Arm
10.8
Actual Duration (Months)
3.2
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Vivity Extended Depth of Focus intraocular lens (IOL)
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 17, 2020
Actual Primary Completion Date :
Jun 10, 2021
Actual Study Completion Date :
Jun 10, 2021

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. Binocular near visual acuity [3 months postop]

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

Secondary Outcome Measures

  1. Prediction accuracy [1 and 3 months postop]

    Percentage of eyes with postoperative refractive accuracy within 0.5D of target

  2. Spectacle independence [3 months postop]

    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. Patient satisfaction [3 months postop]

    Patient satisfaction questionnaire scores (IOLSAT proprietary questionnaire), based on a 0-4 scale, with lower being better.

  4. Visual disturbances [3 months postop]

    Questionnaire for Visual Disturbance scores (QUVID proprietary questionnaire), based on a 0-4 scale with lower being better.

  5. Manifest refraction [1 and 3 months postop]

    Manifest refraction (residual spherical equivalent refraction, residual sphere, and residual astigmatism)

  6. Uncorrected distance visual acuity [1 and 3 months postop]

    Bilateral uncorrected distance visual acuity

  7. Uncorrected intermediate visual acuity [1 and 3 months postop]

    Bilateral uncorrected visual acuity at 66 cm

  8. Uncorrected near visual acuity [1 and 3 months postop]

    Bilateral uncorrected distance visual acuity at 40 cm

  9. Corrected distance visual acuity [1 and 3 months postop]

    Bliateral corrected distance visual acuity

  10. Corrected intermediate visual acuity [1 and 3 months postop]

    Bliateral corrected visual acuity at 66 cm

  11. Corrected near visual acuity [1 and 3 months postop]

    Bliateral corrected visual acuity at 40 cm

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Newsom Eye and Laser CenterSebringFloridaUnited States33870

Sponsors and Collaborators

  • Newsom Eye & Laser Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Newsom Eye & Laser Center
ClinicalTrials.gov Identifier:
NCT04482439
Other Study ID Numbers:
  • TN-20-001
First Posted:
Jul 22, 2020
Last Update Posted:
Aug 26, 2021
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 26, 2021