Visual Outcomes Following Bilateral Implantation of the Vivity Toric Intraocular Lens

December 24, 2023 updated by: Mun Wai Lee, LEC Eye Centre

Visual Outcomes Following Bilateral Implantation of a Non-diffractive Wavefront-shaping Extended Depth of Focus Toric Intraocular Lens

The objective of this study was to evaluate the clinical and patient reported outcomes after bilateral implantation of the AcrySof™ IQ Vivity™ Toric intraocular lens.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective interventional case series of 30 patients who underwent cataract surgery and bilateral implantation of the AcrySof™ IQ Vivity™ Toric intraocular lens. This study is represented by an Asian cohort of patients and the study evaluations were focused not only on clinical visual outcomes but also on "real-life" patient reported outcomes such as dysphotopsias, spectacle independence and daily visual tasks all of which were measured at 1 month and up to 3 months postoperatively. The objective would be to provide insight into the performance of this intraocular lens in Asian patients.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Perak
      • Ipoh, Perak, Malaysia, 30450
        • LEC Eye Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients aged 18 years or older
  • bilateral significant cataracts
  • bilateral significant corneal astigmatism

Exclusion Criteria:

  • previous refractive surgery
  • amblyopia
  • strabismus
  • any ocular co-morbidity which could impact on final visual acuity
  • pre-existing zonular weakness
  • capsular instability or compromise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All eyes
All eyes implanted with AcrySof™ IQ Vivity™ Toric intraocular lens
Device: AcrySof™ IQ Vivity™ Toric intraocular lens
Uneventful phacoemulsification and implantation of IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Binocular UDVA
Time Frame: 3 months
Binocular Uncorrected Distance Visual Acuity
3 months
Binocular UIVA
Time Frame: 3 months
Binocular Uncorrected Intermediate Visual Acuity
3 months
Binocular UNVA
Time Frame: 3 months
Binocular Uncorrected Near Visual Acuity
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CDVA
Time Frame: 3 months
Corrected Distance Visual Acuity
3 months
DCIVA
Time Frame: 3 months
Distance Corrected Intermediate Visual Acuity
3 months
DCNVA
Time Frame: 3 months
Distance Corrected Near Visual Acuity
3 months
MRSE
Time Frame: 3 months
Mean Refractive Spherical Equivalent
3 months
Rotational Stability
Time Frame: 1 month
Degree of rotation of intraocular lens
1 month
Binocular Defocus Curve
Time Frame: 3 months
Measurement of the performance of the Intraocular lens at different distances
3 months
Contrast Sensitivity
Time Frame: 3 months
Measurement of the contrast sensitivity after implantation with this intraocular lens
3 months
QUVID
Time Frame: 3 months
Questionnaire on Visual Disturbances
3 months
VF-14
Time Frame: 3 months
Visual function 14 index of questions designed to assess difficulty performing daily visual tasks
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEC Eye Centre

Collaborators

Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

December 24, 2023

First Submitted That Met QC Criteria

December 24, 2023

First Posted (Actual)

January 9, 2024

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

December 24, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VTLEC

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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