Vivity Study in Taiwan

December 5, 2024 updated by: Chao-Kai Chang, Taipei Nobel Eye Clinic

A Prospective Study of Vivity & Vivity Toric IOL in Taiwan: Results and Analysis

The aim of study is to evaluate the quality of vision after bilateral Vivity or Vivity toric EDOF IOLs implantation in Taiwan.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

This study was a prospective, single arm study. The inclusion criteria for this study were the presence of cataracts in both eyes and corrected distance visual acuity (CDVA) of both eyes under 20/40, who received bilateral Vivity IOL implantation after cataract surgery, targeting emmetropia or mini-monovision of both eyes. Phacoemulsification cataract surgery was performed on all patients. The exclusion criteria were complicated cataract; corneal opacities or irregularities; severe dry eye (Schirmer's test I ≤ 5 mm); amblyopia; anisometropia; surgical complications such as posterior capsular bag rupture, vitreous loss, or IOL tilt/decentration; coexisting ocular pathologies such as glaucoma, nondilating pupil, history of intraocular surgery, refractive surgery, or retinopathy; optic nerve or macular diseases; and refusal or inability to maintain follow-up. When corneal astigmatism was more than 0.75 diopters (D), a toric IOL was implanted.

Study Type

Observational

Enrollment (Estimated)

100

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

  • Taiwan
      • Taipei, Taiwan
        • Taiwan Nobel Eye Clinic

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who intended for sequential bilateral cataract surgery and implanted with Vivity/Vivity IOL would be asked to include in this study.

Description

Inclusion Criteria:

  • Patients with age-related cataract requiring surgery treatment
  • Patient who received bilateral, uneventful implantation of Vivity IOLs
  • Patient's IOL power is between 10-30D, and T2-T6 for toric correction

  • Cataract grade 0~3 based on the Wisconsin cataract grading system

    • Exclusion criteria:

  • Cataract grade 4~5 based on the Wisconsin cataract grading system
  • Patient's IOL power is outside of 10-30D or T2-T6 for toric correction
  • Patient with the following ocular comorbidities:
  • Corneal opacities or irregularities;
  • Severe dry eye;
  • Amblyopia;
  • Glaucoma;
  • Non-dilating pupil;
  • History of intraocular surgery, laser therapy, or retinopathy;
  • Optic nerve or macular diseases;
  • Uncontrolled diabetic mellitus or systemic immune disease;
  • Refusal or unable to maintain follow-up

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

Cohorts and Interventions

Group / Cohort
Vivity/Vivity toric

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity (LogMAR)
Time Frame: From enrollment to the end of treatment at 3 months
Uncorrected binocular far, intermediate and near visual acuity. Corrected binocular far, intermediate and near visual acuity.
From enrollment to the end of treatment at 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intermediate reading speed (seconds)
Time Frame: From enrollment to the end of treatment at 3 months
The intermediate reading speed was measured by IReST - International Reading Speed Texts Chinese Edition
From enrollment to the end of treatment at 3 months

Collaborators and Investigators

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

Sponsor

Taipei Nobel Eye Clinic

Investigators

  • Study Director: ChaoKai Chang, Ph.D., Taiwan Nobel Eye Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 15, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

November 10, 2024

First Submitted That Met QC Criteria

December 5, 2024

First Posted (Estimated)

December 6, 2024

Study Record Updates

Last Update Posted (Estimated)

December 6, 2024

Last Update Submitted That Met QC Criteria

December 5, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 005

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

No

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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