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Completed

NCT Number: NCT04495049

Vivity Insight: A Study of Patient Satisfaction and Visual Performance

This will be a single arm, open-label, prospective study of patient-reported outcomes of patients with bilateral implantation of the Vivity or Vivity Toric implant.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Harvard Eye Associates, Laguna Hills, California, United States

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About this study

Existing diffractive extended depth of focus (EDOF) lenses provide two adjacent "zones" of uncorrected vision (distance and intermediate or intermediate and near) but have a track record of frequent patient dissatisfaction because of unwanted visual side effects, "spider webs" or haloes. The Vivity non-diffractive EDOF lens offers this same range ofvision with contrast sensitivity similar to a monofocal lens, which suggests fewer side effects will be encountered in clinical practice.

This study is designed to measure postoperative patient-reported outcomes with this new lens implant. Previous studies we have conducted on the bilateral ReSTOR 3.0, ReSTOR with ActiveFocus 2.5 (mixed with 3.0 and alone with mini-monovision) have shown high satisfaction, spectacle independence, and acceptable glare and halo profiles using a validated questionnaire instrument developed by MDbackline, Inc. The postoperative portions of this study will be designed to mirror those previous studies using the same instrument.

All subjects will receive the Vivity or Vivity Toric implant binocularly with a target of plano sphere.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with cataract and otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence outcome measures.
  • Patients implanted with Vivity or Vivity Toric lenses bilaterally within 6 months of the survey administration.
  • Patients whose postoperative manifest refraction at the time of the survey is within ± 0.5 D sphere and ≤0.75 D of cylindrical refraction.
  • Patients who have given consent to participate in the survey.

Exclusion criteria

  • Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery.
  • Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL, cystoid macular edema, etc.) that would, the judgement of the investigator, influence the outcome measures of the study.
  • Patients with previous refractive surgery within the past 6 months prior to cataract surgery.
  • Patients with > grade 1 posterior capsule opacity at their last visit.
  • Patients who do not meet the refractive endpoints described in the Inclusion Criteria.

Treatment and study plan

Alcon Vivity or Vivity Toric IOL

Device

Patients who previously underwent cataract surgery with the Alcon Vivity or Vivity Toric IOL in both eyes.

Primary outcomes

  1. Percentage of patients reporting "not at all" or "just a little" when asked, "With or without glasses, how much do you notice glare or haloes around lights in dim light situations?"

    Time frame: 8/1/2020 - 7/1/2021

    Percentage of patients reporting "not at all" or "just a little" when asked, "With or without glasses, how much do you notice glare or haloes around lights in dim light situations?"

Secondary outcomes

  1. Percentage of postoperative patients who report "rarely" when asked "How often do you need glasses to see the computer?"

    Time frame: 8/1/2020 - 7/1/2021

    Percentage of postoperative patients who report "rarely" when asked "How often do you need glasses to see the computer?"

  2. Percentage of postoperative patients who report that they do not require reading glasses for various activities

    Time frame: 8/1/2020 - 7/1/2021

    Percentage of postoperative patients who report that they do not require reading glasses for various activities (driving, reading, including fine print, seeing computer monitor, watching TV, sports/hobbies when asked "For what types of activities do you need glasses to see (other than sunglasses)?"

Other outcomes

  1. Percentage of patients reporting "very satisfied" when asked, "Overall, how satisfied are you with your vision after your latest surgery?"

    Time frame: 8/1/2020 - 7/1/2021

    Percentage of patients reporting "very satisfied" when asked, "Overall, how satisfied are you with your vision after your latest surgery?"

  2. Percentage of patients who report "very satisfied" or "satisfied" to the same question.

    Time frame: 8/1/2020 - 7/1/2021

    Percentage of patients who report "very satisfied" or "satisfied" to the same question.

Sponsors and collaborators

Lead sponsor

Research Insight LLC

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 31, 2020
Registry last updated
Jun 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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