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NCT Number: NCT06719882

Vivity Study in Taiwan

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Taiwan Nobel Eye Clinic

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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.

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Taipei Nobel Eye Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 6, 2024
Registry last updated
Dec 6, 2024

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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